Breast Cancer
Conditions
Brief summary
This randomized, open-label, parallel-group study will assess the efficacy and s afety of Avastin (bevacizumab) in combination with chemotherapy versus chemother apy alone as second- and third-line therapy in patients with locally recurrent o r metastatic breast cancer progressing after first-line therapy with Avastin and chemotherapy. Patients will be randomized to receive either Avastin (15 mg/kg e very 3 weeks or 10 mg/kg every 2 weeks intravenously) plus standard chemotherapy or chemotherapy alone. Anticipated time on study treatment is until third-line disease progression or unacceptable toxicity occurs.
Interventions
DRUGbevacizumab [Avastin]
10 mg/ kg iv every 2 weeks or 15 mg/kg iv every 3 weeks
DRUGChemotherapy
Standard chemotherapy (doublets not allowed)
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female patients, \>/= 18 years of age * Histologically confirmed HER2-negative breast cancer * Disease progression during or following first-line treatment with Avastin and chemotherapy for locally recurrent or metastatic breast cancer * Avastin treatment in first-line setting must have been a minimum of 4 cycles (15 mg/kg) or 6 cycles (10 mg/kg) in combination with chemotherapy * ECOG performance status 0-2 * At least 28 days since prior radiation therapy or surgery and recovery from treatment
Exclusion criteria
* Anti-angiogenic therapy or anti-vascular endothelial growth factors other than Avastin for first-line treatment * Active malignancy other than superficial basal cell and superficial squamous cell carcinoma of the skin, or in situ carcinoma of the cervix or breast within the last 5 years * Inadequate renal function * Clinically relevant cardio-vascular disease * Known CNS disease except for treated brain metastases * Chronic daily treatment with high-dose aspirin (\>325 mg/day) or clopidogrel (\>75 mg/day) * Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Second-Line Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) | Baseline (less than or equal to [≤] 28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years | Second-line PFS was defined as the time from randomization to progressive disease (PD) or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. |
| Second-Line PFS | Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years | The median time, in months, from randomization to second-line PFS event. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. |
| Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 6 | Month 6 | Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. |
| Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 12 | Month 12 | Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without secondline PD or death were censored at the date of last tumor assessment where non-progression was documented. |
| Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 18 | Month 18 | Second-line PFS was defined as the time from randomization to PD or death due to any cause during their secondline of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. |
| Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 24 | Month 24 | Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Third-Line PFS | First dose of third-line treatment until PD or death due to any cause (over a period of approximately 14 months) | The median time, in months, from the first dose of third-line bevacizumab and/or chemotherapy to third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented. |
| Percentage of Participants With Second- and Third-Line PFS According to RECIST v1.1 | Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years | Second- and third-line PFS was defined as the time from the date randomization to the date of third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented. |
| Second- and Third-Line PFS | Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years | The median time, in months, from randomization to second-line and third-line PFS event. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented. |
| Percentage of Participants With Second- and Third-Line Tumor Progression | Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years | Second- and third-line tumor progression was defined as occurrence of third-line PD according to RECIST v1.1 or death due to progression of disease. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death due to progression of disease were censored at the date of last tumor assessment where non-progression was documented. |
| Time to Second- and Third-Line Tumor Progression | Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years | The median time, in months, from randomization to second- and third-line tumor progression. Second- and third-line tumor progression was defined as third-line PD according to RECIST v1.1 or death due to progression of disease. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented. |
| Percentage of Participants Who Died | Baseline until death (up to approximately 4 years) | Percentage of participants who died due to any reason were reported. |
| Overall Survival (OS) | Baseline until death (up to approximately 4 years) | OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Participants who had not died were censored at the date the patient was last known to be alive. |
| Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years | The median time, in months, from randomization to second-line PFS event according to the following baseline risk factors: hormone receptor negative, HER2 negative (triple negative), hormone receptor positive/HER-2 negative (HR-pos/HER-neg), first-line PFS less than (\<) 6 months, first-line PFS greater than or equal to (≥) 6 months, taxane chemotherapy (chemo), non-taxane chemo, vinorelbine chemo, LDH ≤ 1.5 upper limit of normal (ULN), LDH greater than (\>) 1.5 ULN, \< 65 years of age, ≥ 65 years of age, \< 70 years of age, ≥ 70 years of age, \< 3 metastatic organ sites, ≥ 3 metastatic organ sites, bevacizumab-free (B-free) interval ≤ 6 weeks, B-free \> 6 weeks, disease-free (D-free) interval ≤ 24 months, D-free \> 24 months, D-free ≤ 12 months, and D-free \> 12 months. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. PD: defined in Outcome measure 1. The 95% CI was estimated using Kaplan-Meier methodology. |
| Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years) | The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either no problems, some problems, or extreme problems in the following categories: mobility (M) (no problems=I have no problems in walking about to extreme problems=I am confined to bed), self-care (SC) (no problems=I have no problems with self-care to extreme problems=I am unable to wash or dress myself), usual activities (UA) (no problems=I have no problems performing my usual activities to extreme problems=I am unable to perform my usual activities), pain/discomfort (P/D) (no problems=I have no pain or discomfort to extreme problems=I have extreme pain or discomfort), and anxiety/depression (A/D) (no problems=I am not anxious or depressed to extreme problems='I am extremely anxious or depressed). |
| Quality of Life Assessed As an Index Score Using the EQ-5D (Data Cutoff 20 December 2013) | Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years) | The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either no problems, some problems, or extreme problems in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on large population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems). |
| Change From Baseline in EQ-5D Index Scores (Data Cutoff 20 December 2013) | Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years) | The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either no problems, some problems, or extreme problems in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on large population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems) where a negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life. |
| Quality of Life Assessed Using the EQ-5D Visual Analogue Scale (VAS) Scores (Data Cutoff 20 December 2013) | Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years) | The participant was asked to rate their overall health on a 0-100 millimeter (mm) vertical scale, where the lowest endpoint=0 (labeled as worst imaginable health state) and the highest endpoint =100 (labeled as the best imaginable health state). The participant marked the line corresponding to their assessment and the distance from the bottom was measured in millimeters. A higher value indicated a better health state. |
| Change From Baseline in VAS Scores (Data Cutoff 20 December 2013) | Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years) | The participant was asked to rate their overall health on a 0-100 mm vertical scale, where the lowest endpoint = 0 (labeled as worst imaginable health state) and the highest endpoint =100 (labeled as the best imaginable health state). The participant marked the line corresponding to their assessment and the distance from the bottom was measured in millimeters. A negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life. |
| Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Baseline (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD (up to approximately 3 years) | The Functional Assessment of Cancer Therapy-Breast (FACT-B) is composed of 5 multi-item sections where participants responded to questions assessing symptoms (scale: 0-4; 0=not at all and 4=very much), as follows: physical well-being (PWB) (7 items, total score 0-28), social/family well-being (SWB) (7 items, total score 0-28), emotional well-being (EWB) (6 items, total score 0-24), functional well-being (FWB) (7 items, total score 0-28); and breast cancer score based on the additional concerns section of FACT-B (10 items, total score 0-40). The FACT-B Trial Outcomes Index (TOI) score=sum of PWB, FWB, and breast cancer score subscale scores (total score 0-96). The Functional Assessment of Cancer Therapy-General (FACT-G) total score=sum of PWB, SWB, EWB, and FWB subscales scores (total score 0-108). The FACT-B total score=sum of PWB, SWB, EWB, FWB, and breast cancer score subscales scores (total score 0-148). In all cases a higher value indicated a better perceived quality of life. |
| Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Baseline (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD (up to approximately 3 years) | The FACT-B is composed of 5 multi-item sections where participants responded to questions assessing symptoms (scale: 0-4; 0=not at all and 4=very much), as follows: PWB (7 items, total score 0-28), SWB (7 items, total score 0-28), EWB (6 items, total score 0-24), FWB (7 items, total score 0-28); and breast cancer score based on the additional concerns section of FACT-B (10 items, total score 0-40). The FACT-B TOI score=sum of PWB, FWB, and breast cancer score subscale scores (total score 0-96). The FACT-G total score=sum of PWB, SWB, EWB, and FWB subscales scores (total score 0-108). The FACT-B total score=sum of PWB, SWB, EWB, FWB, and breast cancer score subscale scores (total score 0-148). In all cases a higher value indicated a better perceived quality of life. |
| Percentage of Participants Estimated to be Surviving at Months 6, 12, 18, and 24 | Months 6, 12, 18, and 24 | OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. |
| Percentage of Participants With a Second-Line Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 (Data Cutoff 20 December 2013) | Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years | BOR was defined as a confirmed CR or PR during second-line treatment. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% Cl was determined using the Pearson-Clopper method. |
| Percentage of Participants With a Second-Line CR, PR, Stable Disease, and PD According to RECIST v1.1 (Data Cutoff 20 December 2013) | Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years | For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; stable disease was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI was determined using the Pearson-Clopper method. |
| Duration of Second-Line Objective Response (Data Cutoff 20 December 2013) | Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years | The median time, in months, from the date of the first second-line documentation of CR or PR according to RECIST v1.1 to the date of the first second-line documentation of PD or death due to any cause. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants with CR or PR who had experienced neither disease progression nor died were censored at the date of the last available tumor assessment when the participant was known to be progression free. |
| Percentage of Participants With a Second-Line Documented CR or PR According to RECIST v1.1 Estimated to be Alive and Free of Disease Progression at Months 3, 6, and 9 (Data Cutoff 20 December 2013) | Months 3, 6, and 9 | Duration of objective response was defined as the median time, in months, from the date of the first second-line documentation of CR or PR to the date of the first second-line documentation of PD or death due to any cause. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants with CR or PR who had experienced neither disease progression nor died were censored at the date of the last available tumor assessment when the participant was known to be progression free. |
| Percentage of Participants With Third-Line PFS According to RECIST v1.1 | First dose of third-line treatment until PD or death due to any cause (assessed every 8-9 weeks, over a period of approximately 14 months) | Third-line PFS was defined as the time from the date of first dose of third-line bevacizumab and/or chemotherapy to the date of third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented. |
Countries
Argentina, Austria, Brazil, Croatia, France, Germany, Greece, Hungary, Israel, Italy, Slovakia, Spain, Switzerland
Participant flow
Recruitment details
A total of 556 participants were screened and of these, 494 were randomized.
Participants by arm
| Arm | Count |
|---|---|
| CT Arm Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. | 247 |
| CT+BV Arm Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator's site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study. | 247 |
| Total | 494 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 4 |
| Overall Study | Death | 141 | 148 |
| Overall Study | Lost to Follow-up | 9 | 6 |
| Overall Study | Other | 0 | 4 |
| Overall Study | Participant noncompliance | 2 | 0 |
| Overall Study | Physician Decision | 11 | 3 |
| Overall Study | Protocol Violation | 2 | 8 |
| Overall Study | Withdrawal by Subject | 32 | 20 |
Baseline characteristics
| Characteristic | CT Arm | CT+BV Arm | Total |
|---|---|---|---|
| Age, Continuous | 54.7 years STANDARD_DEVIATION 10.83 | 55.8 years STANDARD_DEVIATION 11.17 | 55.2 years STANDARD_DEVIATION 11.01 |
| Sex: Female, Male Female | 247 Participants | 247 Participants | 494 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 181 / 238 | 218 / 245 |
| serious Total, serious adverse events | 55 / 238 | 89 / 245 |
Outcome results
Primary
Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 12
Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without secondline PD or death were censored at the date of last tumor assessment where non-progression was documented.
Time frame: Month 12
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CT Arm | Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 12 | 16.9 percentage of participants |
| CT+BV Arm | Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 12 | 24.2 percentage of participants |
Primary
Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 18
Second-line PFS was defined as the time from randomization to PD or death due to any cause during their secondline of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Time frame: Month 18
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CT Arm | Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 18 | 9.9 percentage of participants |
| CT+BV Arm | Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 18 | 11.0 percentage of participants |
Primary
Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 24
Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Time frame: Month 24
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CT Arm | Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 24 | 6.4 percentage of participants |
| CT+BV Arm | Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 24 | 6.5 percentage of participants |
Primary
Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 6
Second-line PFS was defined as the time from randomization to PD or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Time frame: Month 6
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CT Arm | Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 6 | 40.7 percentage of participants |
| CT+BV Arm | Percentage of Participants Estimated to be Alive and Free of Second-Line Disease Progression at Month 6 | 54.2 percentage of participants |
Primary
Percentage of Participants With Second-Line Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1)
Second-line PFS was defined as the time from randomization to progressive disease (PD) or death due to any cause during their second-line of treatment with bevacizumab and/or chemotherapy, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Time frame: Baseline (less than or equal to [≤] 28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
Population: Intent-to-Treat (ITT) population - all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CT Arm | Percentage of Participants With Second-Line Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) | 88.7 percentage of participants |
| CT+BV Arm | Percentage of Participants With Second-Line Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) | 93.9 percentage of participants |
Primary
Second-Line PFS
The median time, in months, from randomization to second-line PFS event. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Time frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CT Arm | Second-Line PFS | 4.2 months |
| CT+BV Arm | Second-Line PFS | 6.3 months |
p-value: 0.020495% CI: [0.65, 0.97]Log Rank
p-value: 0.024595% CI: [0.67, 0.97]Log Rank
Secondary
Change From Baseline in EQ-5D Index Scores (Data Cutoff 20 December 2013)
The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either no problems, some problems, or extreme problems in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on large population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems) where a negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life.
Time frame: Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)
Population: ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| CT Arm | Change From Baseline in EQ-5D Index Scores (Data Cutoff 20 December 2013) | Week 8/9 (n=107,122) | -0.0103 score on a scale |
| CT Arm | Change From Baseline in EQ-5D Index Scores (Data Cutoff 20 December 2013) | Week 16/18 (n=68,110) | 0.0387 score on a scale |
| CT Arm | Change From Baseline in EQ-5D Index Scores (Data Cutoff 20 December 2013) | Second-line PD (n=69,71) | -0.0884 score on a scale |
| CT+BV Arm | Change From Baseline in EQ-5D Index Scores (Data Cutoff 20 December 2013) | Week 8/9 (n=107,122) | -0.0370 score on a scale |
| CT+BV Arm | Change From Baseline in EQ-5D Index Scores (Data Cutoff 20 December 2013) | Week 16/18 (n=68,110) | -0.0508 score on a scale |
| CT+BV Arm | Change From Baseline in EQ-5D Index Scores (Data Cutoff 20 December 2013) | Second-line PD (n=69,71) | -0.0878 score on a scale |
Secondary
Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013)
The FACT-B is composed of 5 multi-item sections where participants responded to questions assessing symptoms (scale: 0-4; 0=not at all and 4=very much), as follows: PWB (7 items, total score 0-28), SWB (7 items, total score 0-28), EWB (6 items, total score 0-24), FWB (7 items, total score 0-28); and breast cancer score based on the additional concerns section of FACT-B (10 items, total score 0-40). The FACT-B TOI score=sum of PWB, FWB, and breast cancer score subscale scores (total score 0-96). The FACT-G total score=sum of PWB, SWB, EWB, and FWB subscales scores (total score 0-108). The FACT-B total score=sum of PWB, SWB, EWB, FWB, and breast cancer score subscale scores (total score 0-148). In all cases a higher value indicated a better perceived quality of life.
Time frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD (up to approximately 3 years)
Population: ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 24/27: FACT-B TOI (n=38,70) | 0.221 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 8/9: FWB (n=117,128) | -0.226 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 8/9: EWB (n=116,128) | 0.408 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 8/9: PWB (n=118,125) | -1.281 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 8/9: SWB (n=116,125) | 0.356 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 8/9: Breast Cancer Score (n=113,128) | 0.228 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 8/9: FACT-B TOI (n=110,122) | -1.361 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 8/9: Total FACT-G Score (n=110,122) | -0.760 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 8/9: Total FACT-B Score (n=108,120) | -0.728 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 16/18: PWB (n=77,97) | 0.294 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 16/18: SWB (n=74,97) | -0.443 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 16/18: EWB (n=73,98) | 1.197 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 16/18: FWB (n=75,98) | -0.548 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 16/18: Breast Cancer (n=72,97) | 0.578 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 16/18: FACT-TOI (n=68,95) | -0.483 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 16/18: Total FACT-G (n=71,93) | -0.019 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 16/18: Total Fact-B (n=66,93) | -0.007 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 24/27: PWB (n=44,73) | 0.181 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 24/27: SWB (n=44,72) | -0.193 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 24/27: EWB (n=42,72) | 0.867 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 24/27: FWB (n=42,72) | 0.119 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 24/27: Breast Cancer (n=40,72) | -0.038 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 24/27: Total FACT-G (n=40,70) | 0.764 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 24/27: Total FACT-B (n=37,70) | 0.793 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 32/36: PWB (n=25,39) | 0.880 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 32/36: SWB (n=24,40) | -0.388 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 32/36: EWB (n=25,40) | 1.064 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 32/36: FWB (n=25,40) | 1.380 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 32/36: Breast Cancer (n=23,40) | 0.928 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 32/36: FACT-B TOI (n=23,38) | 3.123 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 32/36: Total FACT-G (n=24,39) | 2.617 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 32/36: Total FACT-B (n=22,38) | 3.529 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 40/45: PWB (n=18,25) | 0.137 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 40/45: SWB (n=19,24) | -0.589 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 40/45: EWB (n=18,25) | 0.200 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 40/45: FWB (n=18,25) | 1.417 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 40/45: Breast Cancer (n=18,25) | 1.395 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 40/45: FACT-B TOI (n=16,25) | 2.432 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 40/45: Total FACT-G (n=17,24) | 1.444 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 40/45: Total FACT-B (n=16,24) | 1.916 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 48/54: SWB (n=13,20) | 1.529 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 48/54: FACT-B TOI (n=12,20) | 4.044 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 48/54: PWB (n=13,20) | 1.295 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 48/54: EWB (n=13,20) | 1.492 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 48/54: FWB (n=13,20) | 2.269 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 48/54: Breast Cancer (n=12,20) | 0.599 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 48/54: Total FACT-G (n=13,20) | 6.586 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 48/54: Total FACT-B (n=12,20) | 7.067 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 56/63: PWB (n=8,13) | -2.063 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 56/63: SWB (n=8,13) | -1.500 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 56/63: EWB (n=7,13) | 0.857 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 56/63: FWB (n=7,13) | 0.000 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 56/63: Breast Cancer (n=8,13) | -0.830 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 56/63: FACT-B TOI (n=7,13) | -3.591 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 56/63: Total FACT-G (n=6,13) | -4.083 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 56/63: Total FACT-B (n=6,13) | -5.301 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 64/72: PWB (n=7,9) | 0.000 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 64/72: SWB (n=7,9) | -2.014 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 64/72: EWB (n=7,9) | -0.057 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 64/72: FWB (n=7,9) | 0.214 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 64/72: Breast Cancer (n=7,9) | -2.298 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 64/72: FACT-B TOI (n=7,9) | -2.083 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 64/72: Total FACT-G (n=7,9) | -1.857 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 64/72: Total FACT-B (n=7,9) | -4.155 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 72/81: PWB (n=5,7) | 2.133 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 72/81: SWB (n=4,7) | -1.208 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 72/81: EWB (n=5,7) | -0.600 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 72/81: FWB (n=5,7) | 0.000 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 72/81: Breast Cancer (n=5,6) | -0.461 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 72/81: FACT-B TOI (n=5,6) | 1.672 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 72/81: Total FACT-G (n=4,7) | -0.167 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 72/81: Total FACT-B (n=4,6) | 1.174 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 80/90: PWB (n=2,3) | -3.750 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 80/90: SWB (n=2,3) | -0.875 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 80/90: EWB (n=2,3) | -4.000 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 80/90: FWB (n=2,3) | -1.000 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 80/90: Breast Cancer (n=2,3) | -5.833 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 80/90: FACT-B TOI (n=2,3) | -10.583 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 80/90: Total FACT-G (n=2,3) | -9.625 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 80/90: Total FACT-B (n=2,3) | -15.458 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 88/99: PWB (n=0,1) | NA score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 88/99: SWB (n=0,1) | NA score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 88/99: EWB (n=0,1) | NA score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 88/99: FWB (n=0,1) | NA score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 88/99: Breast Cancer (n=0,1) | NA score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 88/99: FACT TOI (n=0,1) | NA score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 88/99: Total FACT-G (n=0,1) | NA score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 88/99: Total FACT-B (n=0,1) | NA score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 96/108: PWB (n=2,1) | 7.333 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 96/108: SWB (n=2,1) | 2.183 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 96/108: EWB (n=2,1) | 0.000 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 96/108: FWB (n=2,1) | 6.583 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 96/108: Breast Cancer (n=2,1) | 3.167 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 96/108: FACT-B TOI (n=2,1) | 17.083 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 96/108: Total FACT-G (n=2,1) | 16.100 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 96/108: Total FACT-B (n=2,1) | 19.267 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 104/117: PWB (n=1,2) | 3.667 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 104/117: SWB (n=1,1) | 4.200 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 104/117: EWB (n=1,2) | 0.000 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 104/117: FWB (n=1,2) | 8.000 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 104/117: Breast Cancer (n=1,2) | 6.032 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 104/117: FACT-B TOI (n=1,2) | 17.698 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 104/117: Total FACT-G (n=1,1) | 15.867 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 104/117: Total GACT-B (n=1,1) | 21.898 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 112/126: PWB (n=0,1) | NA score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 112/126: SWB (n=0,1) | NA score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 112/126: EWB (n=0,1) | NA score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 112/126: FWB (n=0,1) | NA score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 112/126: Breast Cancer (n=0,1) | NA score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 112/126: FACT-B TOI (n=0,1) | NA score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 112/126: Total FACT-G (n=0,1) | NA score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 112/126: Total FACT-B (n=0,1) | NA score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Second-Line PD: PWB (n=81,77) | -0.871 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Second-Line PD: SWB (n=80,75) | -0.106 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Second-Line PD: EWB (n=80,76) | -0.440 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Second-Line PD: FWB (n=80,76) | -1.415 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Second-Line PD: Breast Cancer (n=77,77) | 0.120 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Second-Line PD: FACT-B TOI (n=74,76) | -2.311 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Second-Line PD: Total FACT-G (n=76,74) | -2.771 score on a scale |
| CT Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Second-Line PD: Total FACT-B (n=72,74) | -2.719 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Second-Line PD: PWB (n=81,77) | -2.507 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 8/9: EWB (n=116,128) | 1.024 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 64/72: Breast Cancer (n=7,9) | 3.086 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 8/9: FWB (n=117,128) | -0.240 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 8/9: SWB (n=116,125) | 0.707 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 96/108: EWB (n=2,1) | 6.000 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 64/72: FACT-B TOI (n=7,9) | 7.235 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 8/9: PWB (n=118,125) | -1.289 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 112/126: SWB (n=0,1) | -4.200 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 64/72: Total FACT-G (n=7,9) | 11.385 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 8/9: Breast Cancer Score (n=113,128) | 0.950 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 96/108: FWB (n=2,1) | -1.333 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 8/9: FACT-B TOI (n=110,122) | -0.357 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 64/72: Total FACT-B (n=7,9) | 14.472 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 8/9: Total FACT-G Score (n=110,122) | 0.369 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Second-Line PD: Breast Cancer (n=77,77) | 0.241 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 8/9: Total FACT-B Score (n=108,120) | 1.342 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 72/81: PWB (n=5,7) | -0.429 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 16/18: PWB (n=77,97) | -1.823 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 96/108: Breast Cancer (n=2,1) | -3.000 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 16/18: SWB (n=74,97) | 0.359 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 72/81: SWB (n=4,7) | 6.829 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 16/18: EWB (n=73,98) | 0.921 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 112/126: EWB (n=0,1) | 5.000 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 16/18: FWB (n=75,98) | -0.517 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 72/81: EWB (n=5,7) | 4.686 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 16/18: Breast Cancer (n=72,97) | 0.546 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 96/108: FACT-B TOI (n=2,1) | -7.333 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 16/18: FACT-TOI (n=68,95) | -1.732 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 72/81: FWB (n=5,7) | 7.381 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 16/18: Total FACT-G (n=71,93) | -0.836 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Second-Line PD: SWB (n=80,75) | -0.766 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 16/18: Total Fact-B (n=66,93) | -0.127 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 72/81: Breast Cancer (n=5,6) | 3.667 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 24/27: PWB (n=44,73) | -1.996 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 96/108: Total FACT-G (n=2,1) | 3.067 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 24/27: SWB (n=44,72) | 1.375 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 72/81: FACT-B TOI (n=5,6) | 8.278 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 24/27: EWB (n=42,72) | 1.217 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 112/126: FWB (n=0,1) | -5.333 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 24/27: FWB (n=42,72) | 0.056 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 72/81: Total FACT-G (n=4,7) | 18.467 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 24/27: Breast Cancer (n=40,72) | 0.078 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 24/27: FACT-B TOI (n=38,70) | -1.573 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 96/108: Total FACT-B (n=2,1) | 0.067 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 24/27: Total FACT-G (n=40,70) | 0.817 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 72/81: Total FACT-B (n=4,6) | 16.906 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 24/27: Total FACT-B (n=37,70) | 1.157 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Second-Line PD: Total FACT-G (n=76,74) | -4.702 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 32/36: PWB (n=25,39) | -1.235 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 80/90: PWB (n=2,3) | -3.000 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 32/36: SWB (n=24,40) | 1.036 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 104/117: PWB (n=1,2) | -2.000 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 32/36: EWB (n=25,40) | 1.555 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 80/90: SWB (n=2,3) | 7.344 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 32/36: FWB (n=25,40) | 1.635 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 112/126: Breast Cancer (n=0,1) | -5.000 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 32/36: Breast Cancer (n=23,40) | 1.278 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 80/90: EWB (n=2,3) | 4.733 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 32/36: FACT-B TOI (n=23,38) | 1.471 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 104/117: SWB (n=1,1) | 8.800 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 32/36: Total FACT-G (n=24,39) | 3.197 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 80/90: FWB (n=2,3) | 2.556 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 32/36: Total FACT-B (n=22,38) | 3.896 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Second-Line PD: EWB (n=80,76) | -0.508 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 40/45: PWB (n=18,25) | -0.680 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 80/90: Breast Cancer (n=2,3) | 3.667 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 40/45: SWB (n=19,24) | 0.951 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 104/117: EWB (n=1,2) | 10.000 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 40/45: EWB (n=18,25) | 1.048 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 80/90: FACT-B TOI (n=2,3) | 3.222 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 40/45: FWB (n=18,25) | 0.857 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 112/126: FACT-B TOI (n=0,1) | -21.333 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 40/45: Breast Cancer (n=18,25) | 0.444 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 80/90: Total FACT-G (n=2,3) | 11.633 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 40/45: FACT-B TOI (n=16,25) | 0.622 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 104/117: FWB (n=1,2) | 2.333 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 40/45: Total FACT-G (n=17,24) | 2.432 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 80/90: Total FACT-B (n=2,3) | 15.300 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 40/45: Total FACT-B (n=16,24) | 2.673 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Second-Line PD: FACT-B TOI (n=74,76) | -3.003 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 88/99: PWB (n=0,1) | -6.000 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 104/117: Breast Cancer (n=1,2) | 4.000 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 48/54: PWB (n=13,20) | -1.833 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 48/54: SWB (n=13,20) | 2.008 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 88/99: SWB (n=0,1) | 23.333 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 48/54: EWB (n=13,20) | 1.710 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 112/126: Total FACT-G (n=0,1) | -15.533 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 48/54: FWB (n=13,20) | 1.592 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 88/99: EWB (n=0,1) | 0.000 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 48/54: Breast Cancer (n=12,20) | 1.897 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 48/54: FACT-B TOI (n=12,20) | 1.656 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 104/117: FACT-B TOI (n=1,2) | 4.333 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 48/54: Total FACT-G (n=13,20) | 3.477 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 88/99: FWB (n=0,1) | 21.000 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 48/54: Total FACT-B (n=12,20) | 5.374 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Second-Line PD: FWB (n=80,76) | -0.773 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 56/63: PWB (n=8,13) | -0.526 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 88/99: Breast Cancer (n=0,1) | 3.000 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 56/63: SWB (n=8,13) | 3.033 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 104/117: Total FACT-G (n=1,1) | 29.800 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 56/63: EWB (n=7,13) | 0.954 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 88/99: FACT TOI (n=0,1) | 18.000 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 56/63: FWB (n=7,13) | 5.654 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 112/126: Total FACT-B (n=0,1) | -20.533 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 56/63: Breast Cancer (n=8,13) | 1.675 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 88/99: Total FACT-G (n=0,1) | 38.333 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 56/63: FACT-B TOI (n=7,13) | 6.803 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 104/117: Total GACT-B (n=1,1) | 38.800 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 56/63: Total FACT-G (n=6,13) | 9.115 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 88/99: Total FACT-B (n=0,1) | 41.333 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 56/63: Total FACT-B (n=6,13) | 10.791 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Second-Line PD: Total FACT-B (n=72,74) | -4.440 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 64/72: PWB (n=7,9) | 0.926 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 96/108: PWB (n=2,1) | -3.000 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 64/72: SWB (n=7,9) | 3.570 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 112/126: PWB (n=0,1) | -11.000 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 64/72: EWB (n=7,9) | 3.667 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 96/108: SWB (n=2,1) | 1.400 score on a scale |
| CT+BV Arm | Change From Baseline in FACT-B Scores (Data Cutoff 20 December 2013) | Week 64/72: FWB (n=7,9) | 3.222 score on a scale |
Secondary
Change From Baseline in VAS Scores (Data Cutoff 20 December 2013)
The participant was asked to rate their overall health on a 0-100 mm vertical scale, where the lowest endpoint = 0 (labeled as worst imaginable health state) and the highest endpoint =100 (labeled as the best imaginable health state). The participant marked the line corresponding to their assessment and the distance from the bottom was measured in millimeters. A negative value indicated a worsening of perceived quality of life and a positive value indicated an improvement of perceived quality of life.
Time frame: Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)
Population: ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| CT Arm | Change From Baseline in VAS Scores (Data Cutoff 20 December 2013) | Week 8/9 (n=106,118) | -2.0 mm |
| CT Arm | Change From Baseline in VAS Scores (Data Cutoff 20 December 2013) | Week 16/18 (n=66,107) | -0.2 mm |
| CT Arm | Change From Baseline in VAS Scores (Data Cutoff 20 December 2013) | Second-line PD (n=70,69) | -5.1 mm |
| CT+BV Arm | Change From Baseline in VAS Scores (Data Cutoff 20 December 2013) | Week 8/9 (n=106,118) | 2.0 mm |
| CT+BV Arm | Change From Baseline in VAS Scores (Data Cutoff 20 December 2013) | Second-line PD (n=70,69) | -1.3 mm |
| CT+BV Arm | Change From Baseline in VAS Scores (Data Cutoff 20 December 2013) | Week 16/18 (n=66,107) | 2.0 mm |
Secondary
Duration of Second-Line Objective Response (Data Cutoff 20 December 2013)
The median time, in months, from the date of the first second-line documentation of CR or PR according to RECIST v1.1 to the date of the first second-line documentation of PD or death due to any cause. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants with CR or PR who had experienced neither disease progression nor died were censored at the date of the last available tumor assessment when the participant was known to be progression free.
Time frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
Population: ITT population; only randomized participants with a CR or PR were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CT Arm | Duration of Second-Line Objective Response (Data Cutoff 20 December 2013) | 10.6 months |
| CT+BV Arm | Duration of Second-Line Objective Response (Data Cutoff 20 December 2013) | 8.3 months |
p-value: 0.982595% CI: [0.51, 1.99]Log Rank
p-value: 0.360195% CI: [0.73, 2.34]Log Rank
Secondary
Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013)
The Functional Assessment of Cancer Therapy-Breast (FACT-B) is composed of 5 multi-item sections where participants responded to questions assessing symptoms (scale: 0-4; 0=not at all and 4=very much), as follows: physical well-being (PWB) (7 items, total score 0-28), social/family well-being (SWB) (7 items, total score 0-28), emotional well-being (EWB) (6 items, total score 0-24), functional well-being (FWB) (7 items, total score 0-28); and breast cancer score based on the additional concerns section of FACT-B (10 items, total score 0-40). The FACT-B Trial Outcomes Index (TOI) score=sum of PWB, FWB, and breast cancer score subscale scores (total score 0-96). The Functional Assessment of Cancer Therapy-General (FACT-G) total score=sum of PWB, SWB, EWB, and FWB subscales scores (total score 0-108). The FACT-B total score=sum of PWB, SWB, EWB, FWB, and breast cancer score subscales scores (total score 0-148). In all cases a higher value indicated a better perceived quality of life.
Time frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter until second-line PD (up to approximately 3 years)
Population: ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the questionnaire at the specified timepoints.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 32/36: PWB (n=26,44) | 22.949 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | BL: SWB (n=214,223) | 20.722 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | BL: EWB (n=215,224) | 14.847 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | BL: FWB (n=215,224) | 16.091 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | BL: Breast Cancer Score (n=210,224) | 24.986 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | BL: FACT-B TOI (n=204,219) | 61.677 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | BL: Total FACT-G Score (n=207,218) | 72.169 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | BL: Total FACT-B Score (n=201,218) | 96.908 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 8/9: PWB (n=129,138) | 20.413 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 8/9: SWB (n=127,135) | 20.833 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 8/9: EWB (n=129,139) | 15.943 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 8/9: FWB (n=129,139) | 16.662 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 8/9: Breast Cancer Score (n=128,139) | 26.276 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 8/9: FACT-B TOI (n=126,136) | 63.547 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 8/9: Total FACT-G Score (n=122,134) | 74.255 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 8/9: Total FACT-B Score (n=123,134) | 100.375 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 16/18: PWB (n=83,107) | 21.733 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 16/18: SWB (n=80,105) | 20.930 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 16/18: EWB (n=80,107) | 17.330 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 16/18: FWB (n=81,106) | 17.055 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 16/18: Breast Cancer (n=81,106) | 26.923 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 16/18: FACT-B TOI (n=78,105) | 65.628 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 16/18: Total FACT-G (n=78,102) | 76.794 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 16/18: Total FACT-B (n=76,103) | 103.503 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 24/27: PWB (n=48,80) | 21.940 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 24/27: SWB (n=47,78) | 20.840 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 24/27: EWB (n=45,78) | 17.098 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 24/27: FWB (n=45,79) | 18.244 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 24/27: Breast Cancer (n=46,79) | 26.067 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 24/27: FACT-B TOI (n=44,77) | 65.882 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 24/27: Total FACT-G (n=44,77) | 78.305 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 24/27: Total FACT-B (n=43,77) | 104.011 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | BL: PWB (n=215,222) | 20.621 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 32/36: SWB (n=25,43) | 22.140 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 32/36: EWB (n=26,44) | 18.385 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 32/36: FWB (n=26,44) | 19.615 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 32/36: Breast Cancer (n=26,43) | 29.568 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 32/36: FACT-B TOI (n=26,42) | 72.132 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 32/36: Total FACT-G (n=25,42) | 83.087 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 32/36: Total FACT-B (n=25,42) | 112.904 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 40/45: PWB (n=20,27) | 22.215 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 40/45: SWB (n=21,26) | 19.658 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 48/54: Total FACT-B (n=13,23) | 110.806 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 48/54: FWB (n=13,23) | 18.538 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 48/54: Breast Cancer (n=13,23) | 28.912 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 48/54: Fact-B TOI (n=13,23) | 70.758 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 48/54: Total FACT-G (n=13,23) | 81.894 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 56/63: PWB (n=8,14) | 21.792 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 56/63: SWB (n=8,14) | 19.583 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 56/63: EWB (n=7,14) | 17.143 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 56/63: FWB (n=7,14) | 17.143 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 56/63: Breast Cancer (n=8,14) | 28.240 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 56/63: FACT-B TOI (n=7,14) | 66.179 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 56/63: Total FACT-G (n=6,14) | 73.667 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 56/63: Total FACT-B (n=6,14) | 101.042 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 64/72: PWB (n=7,9) | 21.857 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 64/72: SWB (n=7,9) | 18.976 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 64/72: EWB (n=7,9) | 18.143 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 64/72: FWB (n=7,9) | 18.429 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 64/72: Breast Cancer (n=7,9) | 27.464 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 64/72: FACT-B TOI (n=7,9) | 67.750 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 64/72: Total FACT-G (n=7,9) | 77.405 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 64/72: Total FACT-B (n=7,9) | 104.869 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 72/81: PWB (n=6,7) | 23.083 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 72/81: SWB (n=5,7) | 19.667 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 72/81: EWB (n=6,7) | 17.500 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 72/81: FWB (n=6,7) | 17.333 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 72/81: Breast Cancer (n=6,6) | 28.597 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 72/81: FACT-B TOI (n=6,6) | 69.014 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 72/81: Total FACT-G (n=5,7) | 76.467 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 72/81: Total FACT-B (n=5,6) | 106.117 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 80/90: PWB (n=2,3) | 19.250 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 80/90: SWB (n=2,3) | 18.375 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 80/90: EWB (n=2,3) | 14.000 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 80/90: FWB (n=2,3) | 15.000 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 80/90: Breast Cancer (n=2,3) | 21.667 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 80/90: FACT-B TOI (n=2,3) | 55.917 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 80/90: Total FACT-G (n=2,3) | 66.625 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 80/90: Total FACT-B (n=2,3) | 88.292 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 88/99: PWB (n=0,1) | NA score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 88/99: SWB (n=0,1) | NA score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 88/99: EWB (n=0,1) | NA score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 88/99: FWB (n=0,1) | NA score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 88/99: Breast Cancer (n=0,1) | NA score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 88/99: FACT-B TOI (n=0,1) | NA score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 88/99: Total FACT-G (n=0,1) | NA score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 88/99: Total FACT-B (n=0,1) | NA score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 96/108: PWB (n=2,1) | 26.000 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 96/108: SWB (n=2,1) | 24.383 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 96/108: EWB (n=2,2) | 22.000 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 96/108: FWB (n=2,2) | 21.083 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 96/108: Breast Cancer (n=2,2) | 30.389 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 96/108: FACT-B TOI (n=2,1) | 77.472 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 96/108: Total FACT-G (n=2,1) | 93.467 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 96/108: Total FACT-B (n=2,1) | 123.856 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 104/117: PWB (n=1,3) | 27.000 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 104/117: SWB (n=1,2) | 26.600 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 104/117: EWB (n=1,3) | 22.000 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 104/117: FWB (n=1,3) | 22.000 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 104/117: Breast Cancer (n=1,3) | 27.143 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 104/117: FACT-B TOI (n=1,3) | 76.143 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 104/117: Total FACT-G (n=1,2) | 97.600 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 104/117: Total FACT-B (n=1,2) | 124.743 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 112/126: PWB (n=0,1) | NA score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 112/126: SWB (n=0,1) | NA score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 112/126: EWB (n=0,1) | NA score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 112/126: FWB (n=0,1) | NA score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 112/126: Breast Cancer (n=0,1) | NA score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 112/126: FACT-B TOI (n=0,1) | NA score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 112/126: Total FACT-G (n=0,1) | NA score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 112/126: Total FACT-B (n=0,1) | NA score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Second-Line PD: PWB (n=89,81) | 19.086 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Second-Line PD: SWB (n=88,79) | 20.623 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Second-Line PD: EWB (n=88,80) | 15.111 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Second-Line PD: FWB (n=88,80) | 15.447 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Second-Line PD: Breast Cancer (n=85,81) | 24.978 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Second-Line PD: FACT-B TOI (n=84,80) | 59.230 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Second-Line PD: Total FACT-G (n=86,78) | 69.829 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Second-Line PD: Total FACT-B (n=82,78) | 94.930 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 40/45: EWB (n=20,27) | 17.560 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 40/45: FWB (n=20,27) | 18.450 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 40/45: Breast Cancer (n=21,27) | 29.386 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 40/45: FACT-B TOI (n=19,27) | 68.750 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 40/45: Total FACT-G (n=19,26) | 76.955 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 40/45: Total FACT-B (n=19,26) | 105.540 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 48/54: PWB (n=13,24) | 23.308 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 48/54: SWB (n=13,23) | 20.740 score on a scale |
| CT Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 48/54: EWB (n=13,23) | 19.308 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 72/81: PWB (n=6,7) | 21.000 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | BL: PWB (n=215,222) | 20.253 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 104/117: PWB (n=1,3) | 21.333 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | BL: SWB (n=214,223) | 20.674 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 72/81: SWB (n=5,7) | 20.043 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | BL: EWB (n=215,224) | 15.062 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Second-Line PD: PWB (n=89,81) | 17.412 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | BL: FWB (n=215,224) | 15.726 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 72/81: EWB (n=6,7) | 18.114 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | BL: Breast Cancer Score (n=210,224) | 24.388 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 104/117: SWB (n=1,2) | 20.5000 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | BL: FACT-B TOI (n=204,219) | 60.277 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 72/81: FWB (n=6,7) | 16.429 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | BL: Total FACT-G Score (n=207,218) | 71.864 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 40/45: EWB (n=20,27) | 16.067 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | BL: Total FACT-B Score (n=201,218) | 96.115 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 72/81: Breast Cancer (n=6,6) | 25.333 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 8/9: PWB (n=129,138) | 19.156 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 104/117: EWB (n=1,3) | 18.000 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 8/9: SWB (n=127,135) | 21.116 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 72/81: FACT-B TOI (n=6,6) | 60.833 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 8/9: EWB (n=129,139) | 16.671 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Second-Line PD: SWB (n=88,79) | 21.487 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 8/9: FWB (n=129,139) | 16.169 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 72/81: Total FACT-G (n=5,7) | 75.586 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 8/9: Breast Cancer Score (n=128,139) | 25.884 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 104/117: FWB (n=1,3) | 11.000 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 8/9: FACT-B TOI (n=126,136) | 61.279 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 72/81: Total FACT-B (n=5,6) | 97.211 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 8/9: Total FACT-G Score (n=122,134) | 73.393 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 40/45: Total FACT-G (n=19,26) | 75.235 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 8/9: Total FACT-B Score (n=123,134) | 99.213 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 80/90: PWB (n=2,3) | 18.000 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 16/18: PWB (n=83,107) | 19.629 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 104/117: Breast Cancer (n=1,3) | 28.000 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 16/18: SWB (n=80,105) | 20.843 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 80/90: SWB (n=2,3) | 19.944 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 16/18: EWB (n=80,107) | 16.806 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Second-Line PD: EWB (n=88,80) | 14.175 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 16/18: FWB (n=81,106) | 15.920 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 80/90: EWB (n=2,3) | 15.733 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 16/18: Breast Cancer (n=81,106) | 25.755 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 104/117: FACT-B TOI (n=1,3) | 60.333 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 16/18: FACT-B TOI (n=78,105) | 61.107 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 80/90: FWB (n=2,3) | 12.333 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 16/18: Total FACT-G (n=78,102) | 73.269 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 40/45: FWB (n=20,27) | 16.519 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 16/18: Total FACT-B (n=76,103) | 98.906 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 80/90: Breast Cancer (n=2,3) | 25.000 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 24/27: PWB (n=48,80) | 18.965 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 104/117: Total FACT-G (n=1,2) | 70.500 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 24/27: SWB (n=47,78) | 21.399 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 80/90: FACT-B TOI (n=2,3) | 55.333 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 24/27: EWB (n=45,78) | 16.438 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Second-Line PD: FWB (n=88,80) | 15.235 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 24/27: FWB (n=45,79) | 16.051 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 80/90: Total FACT-G (n=2,3) | 66.011 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 24/27: Breast Cancer (n=46,79) | 24.632 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 104/117: Total FACT-B (n=1,2) | 100.500 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 24/27: FACT-B TOI (n=44,77) | 60.014 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 80/90: Total FACT-B (n=2,3) | 91.011 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 24/27: Total FACT-G (n=44,77) | 73.083 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 48/54: PWB (n=13,24) | 20.033 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 24/27: Total FACT-B (n=43,77) | 97.795 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 88/99: PWB (n=0,1) | 22.000 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 32/36: PWB (n=26,44) | 19.686 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 112/126: PWB (n=0,1) | 14.000 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 32/36: SWB (n=25,43) | 21.222 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 88/99: SWB (n=0,1) | 23.333 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 32/36: EWB (n=26,44) | 16.755 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Second-Line PD: Breast Cancer (n=85,81) | 24.445 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 32/36: FWB (n=26,44) | 17.195 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 88/99: EWB (n=0,1) | 20.000 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 32/36: Breast Cancer (n=26,43) | 26.163 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 112/126: SWB (n=0,1) | 15.400 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 32/36: FACT-B TOI (n=26,42) | 63.017 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 88/99: FWB (n=0,1) | 21.000 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 32/36: Total FACT-G (n=25,42) | 74.879 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 40/45: Breast Cancer (n=21,27) | 23.819 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 32/36: Total FACT-B (n=25,42) | 100.904 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 88/99: Breast Cancer (n=0,1) | 35.000 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 40/45: PWB (n=20,27) | 20.630 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 112/126: EWB (n=0,1) | 15.000 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 40/45: SWB (n=21,26) | 20.915 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 88/99: FACT-B TOI (n=0,1) | 78.000 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 48/54: EWB (n=13,23) | 17.270 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Second-Line PD: FACT-B TOI (n=84,80) | 57.002 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 48/54: FWB (n=13,23) | 16.268 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 88/99: Total FACT-G (n=0,1) | 86.333 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 48/54: Breast Cancer (n=13,23) | 26.237 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 112/126: FWB (n=0,1) | 11.000 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 48/54: Fact-B TOI (n=13,23) | 62.679 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 88/99: Total FACT-B (n=0,1) | 121.333 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 48/54: Total FACT-G (n=13,23) | 74.162 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 48/54: Total FACT-B (n=13,23) | 100.399 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 40/45: Total FACT-B (n=19,26) | 99.072 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 56/63: PWB (n=8,14) | 20.298 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 96/108: PWB (n=2,1) | 22.000 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 56/63: SWB (n=8,14) | 20.817 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 112/126: Breast Cancer (n=0,1) | 20.000 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 56/63: EWB (n=7,14) | 15.714 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 96/108: SWB (n=2,1) | 21.000 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 56/63: FWB (n=7,14) | 16.476 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Second-Line PD: Total FACT-G (n=86,78) | 68.485 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 56/63: Breast Cancer (n=8,14) | 25.459 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 96/108: EWB (n=2,2) | 18.000 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 56/63: FACT-B TOI (n=7,14) | 62.233 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 112/126: FACT-B TOI (n=0,1) | 45.000 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 56/63: Total FACT-G (n=6,14) | 73.305 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 96/108: FWB (n=2,2) | 10.500 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 56/63: Total FACT-B (n=6,14) | 98.764 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 40/45: FACT-B TOI (n=19,27) | 60.967 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 64/72: PWB (n=7,9) | 21.889 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 96/108: Breast Cancer (n=2,2) | 24.500 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 64/72: SWB (n=7,9) | 22.685 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 112/126: Total FACT-G (n=0,1) | 55.400 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 64/72: EWB (n=7,9) | 17.889 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 96/108: FACT-B TOI (n=2,1) | 59.000 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 64/72: FWB (n=7,9) | 16.037 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Second-Line PD: Total FACT-B (n=82,78) | 92.983 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 64/72: Breast Cancer (n=7,9) | 26.889 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 96/108: Total FACT-G (n=2,1) | 74.000 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 64/72: FACT-B TOI (n=7,9) | 64.815 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 112/126: Total FACT-B (n=0,1) | 75.400 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 64/72: Total FACT-G (n=7,9) | 78.500 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 96/108: Total FACT-B (n=2,1) | 96.000 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 64/72: Total FACT-B (n=7,9) | 105.389 score on a scale |
| CT+BV Arm | Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores (Data Cutoff 20 December 2013) | Week 48/54: SWB (n=13,23) | 20.450 score on a scale |
Secondary
Overall Survival (OS)
OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Participants who had not died were censored at the date the patient was last known to be alive.
Time frame: Baseline until death (up to approximately 4 years)
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CT Arm | Overall Survival (OS) | 18.7 months |
| CT+BV Arm | Overall Survival (OS) | 19.7 months |
p-value: 0.725395% CI: [0.76, 1.21]Log Rank
p-value: 0.533295% CI: [0.75, 1.16]Log Rank
Secondary
Percentage of Participants Estimated to be Surviving at Months 6, 12, 18, and 24
OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause.
Time frame: Months 6, 12, 18, and 24
Population: ITT population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CT Arm | Percentage of Participants Estimated to be Surviving at Months 6, 12, 18, and 24 | Month 6 | 85.2 percentage of participants |
| CT Arm | Percentage of Participants Estimated to be Surviving at Months 6, 12, 18, and 24 | Month 12 | 68.6 percentage of participants |
| CT Arm | Percentage of Participants Estimated to be Surviving at Months 6, 12, 18, and 24 | Month 18 | 52.8 percentage of participants |
| CT Arm | Percentage of Participants Estimated to be Surviving at Months 6, 12, 18, and 24 | Month 24 | 38.4 percentage of participants |
| CT+BV Arm | Percentage of Participants Estimated to be Surviving at Months 6, 12, 18, and 24 | Month 24 | 37.6 percentage of participants |
| CT+BV Arm | Percentage of Participants Estimated to be Surviving at Months 6, 12, 18, and 24 | Month 6 | 90.4 percentage of participants |
| CT+BV Arm | Percentage of Participants Estimated to be Surviving at Months 6, 12, 18, and 24 | Month 18 | 54.9 percentage of participants |
| CT+BV Arm | Percentage of Participants Estimated to be Surviving at Months 6, 12, 18, and 24 | Month 12 | 72.4 percentage of participants |
Secondary
Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013)
The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either no problems, some problems, or extreme problems in the following categories: mobility (M) (no problems=I have no problems in walking about to extreme problems=I am confined to bed), self-care (SC) (no problems=I have no problems with self-care to extreme problems=I am unable to wash or dress myself), usual activities (UA) (no problems=I have no problems performing my usual activities to extreme problems=I am unable to perform my usual activities), pain/discomfort (P/D) (no problems=I have no pain or discomfort to extreme problems=I have extreme pain or discomfort), and anxiety/depression (A/D) (no problems=I am not anxious or depressed to extreme problems='I am extremely anxious or depressed).
Time frame: Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)
Population: ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants completing the questionnaires at the corresponding timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 8/9: M, no problems (n=133,141) | 61.7 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Second-line PD: UA, extreme problems (n=82,76) | 6.1 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 8/9: M, some problems (n=133,141) | 34.6 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | BL: M, some problems (n=214,224) | 36.4 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 8/9: M, extreme problems (n=133,141) | 1.5 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Second-line PD: M, some problems (n=82,76) | 34.1 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 8/9: SC, no problems (n=133,141) | 82.0 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | BL: M, extreme problems (n=214,224) | 0.5 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 8/9: SC, some problems (n=133,141) | 13.5 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Second-line PD: P/D, no problems (n=82,76) | 19.5 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 8/9: SC, extreme problems (n=133,141) | 1.5 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | BL: SC, no problems (n=214,224) | 82.7 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 8/9: UA, no problems (n=133,141) | 53.4 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Second-line PD: SC, extreme problems (n=82,76) | 1.2 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 8/9: UA, some problems (n=133,141) | 40.6 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | BL: SC, some problems (n=214,224) | 12.6 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 8/9: UA, extreme problems (n=133,141) | 3.0 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Second-line PD: P/D, some problems (n=82,76) | 67.1 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 8/9: P/D, no problems (n=133,141) | 29.3 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | BL: SC, extreme problems (n=214,224) | 0.5 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 8/9: P/D, some problems (n=133,141) | 61.7 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Second-line PD: SC, no problems (n=82,76) | 76.8 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 8/9: P/D, extreme problems (n=133,141) | 5.3 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | BL: UA, no problems (n=214,224) | 53.7 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 8/9: A/D, no problems (n=133,141) | 49.6 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Second-line PD: P/D, extreme problems (n=82,76) | 8.5 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 8/9: A/D, some problems (n=133,141) | 40.6 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | BL: UA, some problems (n=214,224) | 40.2 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 8/9: A/D, extreme problems (n=133,141) | 6.8 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Second-line PD: UA, no problems (n=82,76) | 39.0 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 16/18: M, no problems (n=84,123) | 66.7 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | BL: UA, extreme problems (n=214,224) | 2.8 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 16/18: M, some problems (n=84,123) | 29.8 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Second-line PD: A/D, no problems (n=82,76) | 36.6 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 16/18: M, extreme problems (n=84,123) | 0.0 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | BL: P/D, no problems (n=214,224) | 24.3 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 16/18: SC, no problems (n=84,123) | 81.0 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Second-line PD: M, extreme problems (n=82,76) | 2.4 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 16/18: SC, some problems (n=84,123) | 14.3 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | BL: P/D, some problems (n=214,224) | 68.7 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 16/18: SC, extreme problems (n=84,123) | 0.0 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Second-line PD: A/D, some problems (n=82,76) | 50.0 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 16/18: UA, no problems (n=84,123) | 50.0 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | BL: P/D, extreme problems (n=214,224) | 4.2 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 16/18: UA, some problems (n=84,123) | 42.9 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Second-line PD: UA, some problems (n=82,76) | 50.0 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 16/18: UA, extreme problems (n=84,123) | 3.6 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | BL: A/D, no problems (n=214,224) | 33.6 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 16/18: P/D, no problems (n=84,123) | 34.5 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Second-line PD: A/D, extreme problems (n=82,76) | 7.3 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 16/18: P/D, some problems (n=84,123) | 59.5 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | BL: A/D, some problems (n=214,224) | 56.5 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 16/18: P/D, extreme problems (n=84,123) | 1.2 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Second-line PD: SC, some problems (n=82,76) | 15.9 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 16/18: A/D, no problems (n=84,123) | 51.2 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | BL: A/D, extreme problems (n=214,224) | 5.6 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 16/18: A/D, some problems (n=84,123) | 44.0 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | BL: M, no problems (n=214,224) | 60.3 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 16/18: A/D, extreme problems (n=84,123) | 0.0 percentage of participants |
| CT Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Second-line PD: M, no problems (n=82,76) | 59.8 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 16/18: A/D, extreme problems (n=84,123) | 5.7 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Second-line PD: M, no problems (n=82,76) | 47.4 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Second-line PD: M, some problems (n=82,76) | 48.7 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Second-line PD: M, extreme problems (n=82,76) | 3.9 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Second-line PD: SC, no problems (n=82,76) | 75.0 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Second-line PD: SC, some problems (n=82,76) | 18.4 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Second-line PD: SC, extreme problems (n=82,76) | 6.6 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Second-line PD: UA, no problems (n=82,76) | 30.3 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Second-line PD: UA, some problems (n=82,76) | 59.2 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Second-line PD: UA, extreme problems (n=82,76) | 10.5 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Second-line PD: P/D, no problems (n=82,76) | 18.4 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Second-line PD: P/D, some problems (n=82,76) | 69.7 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Second-line PD: P/D, extreme problems (n=82,76) | 11.8 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Second-line PD: A/D, no problems (n=82,76) | 26.3 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Second-line PD: A/D, some problems (n=82,76) | 61.8 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Second-line PD: A/D, extreme problems (n=82,76) | 11.8 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | BL: M, no problems (n=214,224) | 64.3 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | BL: M, some problems (n=214,224) | 34.8 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | BL: M, extreme problems (n=214,224) | 0.4 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | BL: SC, no problems (n=214,224) | 85.7 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | BL: SC, some problems (n=214,224) | 11.2 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | BL: SC, extreme problems (n=214,224) | 1.8 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | BL: UA, no problems (n=214,224) | 46.4 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | BL: UA, some problems (n=214,224) | 48.7 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | BL: UA, extreme problems (n=214,224) | 4.0 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | BL: P/D, no problems (n=214,224) | 27.7 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | BL: P/D, some problems (n=214,224) | 66.1 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | BL: P/D, extreme problems (n=214,224) | 5.4 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | BL: A/D, no problems (n=214,224) | 34.8 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | BL: A/D, some problems (n=214,224) | 58.5 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | BL: A/D, extreme problems (n=214,224) | 5.8 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 8/9: M, no problems (n=133,141) | 51.8 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 8/9: M, some problems (n=133,141) | 43.3 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 8/9: M, extreme problems (n=133,141) | 2.1 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 8/9: SC, no problems (n=133,141) | 75.9 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 8/9: SC, some problems (n=133,141) | 17.0 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 8/9: SC, extreme problems (n=133,141) | 3.5 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 8/9: UA, no problems (n=133,141) | 40.4 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 8/9: UA, some problems (n=133,141) | 51.8 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 8/9: UA, extreme problems (n=133,141) | 5.0 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 8/9: P/D, no problems (n=133,141) | 23.4 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 8/9: P/D, some problems (n=133,141) | 68.1 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 8/9: P/D, extreme problems (n=133,141) | 6.4 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 8/9: A/D, no problems (n=133,141) | 46.8 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 8/9: A/D, some problems (n=133,141) | 48.2 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 8/9: A/D, extreme problems (n=133,141) | 2.8 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 16/18: M, no problems (n=84,123) | 49.6 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 16/18: M, some problems (n=84,123) | 47.2 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 16/18: M, extreme problems (n=84,123) | 2.4 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 16/18: SC, no problems (n=84,123) | 78.9 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 16/18: SC, some problems (n=84,123) | 17.1 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 16/18: SC, extreme problems (n=84,123) | 3.3 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 16/18: UA, no problems (n=84,123) | 36.6 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 16/18: UA, some problems (n=84,123) | 56.1 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 16/18: UA, extreme problems (n=84,123) | 4.1 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 16/18: P/D, no problems (n=84,123) | 19.5 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 16/18: P/D, some problems (n=84,123) | 76.4 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 16/18: P/D, extreme problems (n=84,123) | 3.3 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 16/18: A/D, no problems (n=84,123) | 49.6 percentage of participants |
| CT+BV Arm | Percentage of Participants Experiencing Problems by European Quality of Life Instrument (EQ-5D) Category (Data Cutoff 20 December 2013) | Week 16/18: A/D, some problems (n=84,123) | 43.1 percentage of participants |
Secondary
Percentage of Participants Who Died
Percentage of participants who died due to any reason were reported.
Time frame: Baseline until death (up to approximately 4 years)
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CT Arm | Percentage of Participants Who Died | 63.2 percentage of participants |
| CT+BV Arm | Percentage of Participants Who Died | 66.0 percentage of participants |
Secondary
Percentage of Participants With a Second-Line Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 (Data Cutoff 20 December 2013)
BOR was defined as a confirmed CR or PR during second-line treatment. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% Cl was determined using the Pearson-Clopper method.
Time frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
Population: ITT population; only randomized participants with measurable disease at baseline were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CT Arm | Percentage of Participants With a Second-Line Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 (Data Cutoff 20 December 2013) | 16.8 percentage of participants |
| CT+BV Arm | Percentage of Participants With a Second-Line Best Overall Response (BOR) of Complete Response (CR) or Partial Response (PR) According to RECIST v1.1 (Data Cutoff 20 December 2013) | 20.9 percentage of participants |
p-value: 0.345795% CI: [-4.2, 12.4]Chi-squared
Secondary
Percentage of Participants With a Second-Line CR, PR, Stable Disease, and PD According to RECIST v1.1 (Data Cutoff 20 December 2013)
For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; stable disease was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI was determined using the Pearson-Clopper method.
Time frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
Population: ITT population; only randomized participants with measurable disease at baseline were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CT Arm | Percentage of Participants With a Second-Line CR, PR, Stable Disease, and PD According to RECIST v1.1 (Data Cutoff 20 December 2013) | PR | 15.7 percentage of participants |
| CT Arm | Percentage of Participants With a Second-Line CR, PR, Stable Disease, and PD According to RECIST v1.1 (Data Cutoff 20 December 2013) | PD | 41.1 percentage of participants |
| CT Arm | Percentage of Participants With a Second-Line CR, PR, Stable Disease, and PD According to RECIST v1.1 (Data Cutoff 20 December 2013) | Stable disease | 33.5 percentage of participants |
| CT Arm | Percentage of Participants With a Second-Line CR, PR, Stable Disease, and PD According to RECIST v1.1 (Data Cutoff 20 December 2013) | Unable to assess | 8.6 percentage of participants |
| CT Arm | Percentage of Participants With a Second-Line CR, PR, Stable Disease, and PD According to RECIST v1.1 (Data Cutoff 20 December 2013) | CR | 1.1 percentage of participants |
| CT+BV Arm | Percentage of Participants With a Second-Line CR, PR, Stable Disease, and PD According to RECIST v1.1 (Data Cutoff 20 December 2013) | Unable to assess | 6.0 percentage of participants |
| CT+BV Arm | Percentage of Participants With a Second-Line CR, PR, Stable Disease, and PD According to RECIST v1.1 (Data Cutoff 20 December 2013) | CR | 0.5 percentage of participants |
| CT+BV Arm | Percentage of Participants With a Second-Line CR, PR, Stable Disease, and PD According to RECIST v1.1 (Data Cutoff 20 December 2013) | PR | 20.3 percentage of participants |
| CT+BV Arm | Percentage of Participants With a Second-Line CR, PR, Stable Disease, and PD According to RECIST v1.1 (Data Cutoff 20 December 2013) | Stable disease | 48.9 percentage of participants |
| CT+BV Arm | Percentage of Participants With a Second-Line CR, PR, Stable Disease, and PD According to RECIST v1.1 (Data Cutoff 20 December 2013) | PD | 24.2 percentage of participants |
Secondary
Percentage of Participants With a Second-Line Documented CR or PR According to RECIST v1.1 Estimated to be Alive and Free of Disease Progression at Months 3, 6, and 9 (Data Cutoff 20 December 2013)
Duration of objective response was defined as the median time, in months, from the date of the first second-line documentation of CR or PR to the date of the first second-line documentation of PD or death due to any cause. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline SLD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels, and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants with CR or PR who had experienced neither disease progression nor died were censored at the date of the last available tumor assessment when the participant was known to be progression free.
Time frame: Months 3, 6, and 9
Population: ITT population; only randomized participants with a CR or PR were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CT Arm | Percentage of Participants With a Second-Line Documented CR or PR According to RECIST v1.1 Estimated to be Alive and Free of Disease Progression at Months 3, 6, and 9 (Data Cutoff 20 December 2013) | Month 3 | 96.7 percentage of participants |
| CT Arm | Percentage of Participants With a Second-Line Documented CR or PR According to RECIST v1.1 Estimated to be Alive and Free of Disease Progression at Months 3, 6, and 9 (Data Cutoff 20 December 2013) | Month 6 | 69.0 percentage of participants |
| CT Arm | Percentage of Participants With a Second-Line Documented CR or PR According to RECIST v1.1 Estimated to be Alive and Free of Disease Progression at Months 3, 6, and 9 (Data Cutoff 20 December 2013) | Month 9 | 60.9 percentage of participants |
| CT+BV Arm | Percentage of Participants With a Second-Line Documented CR or PR According to RECIST v1.1 Estimated to be Alive and Free of Disease Progression at Months 3, 6, and 9 (Data Cutoff 20 December 2013) | Month 3 | 100.0 percentage of participants |
| CT+BV Arm | Percentage of Participants With a Second-Line Documented CR or PR According to RECIST v1.1 Estimated to be Alive and Free of Disease Progression at Months 3, 6, and 9 (Data Cutoff 20 December 2013) | Month 6 | 72.8 percentage of participants |
| CT+BV Arm | Percentage of Participants With a Second-Line Documented CR or PR According to RECIST v1.1 Estimated to be Alive and Free of Disease Progression at Months 3, 6, and 9 (Data Cutoff 20 December 2013) | Month 9 | 40.8 percentage of participants |
Secondary
Percentage of Participants With Second- and Third-Line PFS According to RECIST v1.1
Second- and third-line PFS was defined as the time from the date randomization to the date of third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Time frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CT Arm | Percentage of Participants With Second- and Third-Line PFS According to RECIST v1.1 | 71.7 percentage of participants |
| CT+BV Arm | Percentage of Participants With Second- and Third-Line PFS According to RECIST v1.1 | 83.4 percentage of participants |
Secondary
Percentage of Participants With Second- and Third-Line Tumor Progression
Second- and third-line tumor progression was defined as occurrence of third-line PD according to RECIST v1.1 or death due to progression of disease. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death due to progression of disease were censored at the date of last tumor assessment where non-progression was documented.
Time frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CT Arm | Percentage of Participants With Second- and Third-Line Tumor Progression | 67.2 percentage of participants |
| CT+BV Arm | Percentage of Participants With Second- and Third-Line Tumor Progression | 75.3 percentage of participants |
Secondary
Percentage of Participants With Third-Line PFS According to RECIST v1.1
Third-line PFS was defined as the time from the date of first dose of third-line bevacizumab and/or chemotherapy to the date of third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Time frame: First dose of third-line treatment until PD or death due to any cause (assessed every 8-9 weeks, over a period of approximately 14 months)
Population: Third line ITT population: all randomized participants who received third-line treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CT Arm | Percentage of Participants With Third-Line PFS According to RECIST v1.1 | 94.3 percentage of participants |
| CT+BV Arm | Percentage of Participants With Third-Line PFS According to RECIST v1.1 | 96.1 percentage of participants |
Secondary
Quality of Life Assessed As an Index Score Using the EQ-5D (Data Cutoff 20 December 2013)
The EQ-5D is composed of 5 single-item measures where participants responded to questions assessing health status by responding with either no problems, some problems, or extreme problems in the following categories: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Based on large population surveys, an algorithm was used to combine the responses to each of these 5 measures into 1 single EQ-5D index score ranging from -0.59 (extreme problems) to +1 (no problems).
Time frame: Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)
Population: ITT population. Here, Number of participants analyzed = participants evaluable for this outcome measure and n=number of participants who completed the assessment at the specified timepoint
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| CT Arm | Quality of Life Assessed As an Index Score Using the EQ-5D (Data Cutoff 20 December 2013) | BL (n=202,219) | 0.6806 score on a scale |
| CT Arm | Quality of Life Assessed As an Index Score Using the EQ-5D (Data Cutoff 20 December 2013) | Week 8/9 (n=127,135) | 0.6953 score on a scale |
| CT Arm | Quality of Life Assessed As an Index Score Using the EQ-5D (Data Cutoff 20 December 2013) | Week 16/18 (n=80,118) | 0.7496 score on a scale |
| CT Arm | Quality of Life Assessed As an Index Score Using the EQ-5D (Data Cutoff 20 December 2013) | Second-line PD (n=77,76) | 0.6290 score on a scale |
| CT+BV Arm | Quality of Life Assessed As an Index Score Using the EQ-5D (Data Cutoff 20 December 2013) | Second-line PD (n=77,76) | 0.5553 score on a scale |
| CT+BV Arm | Quality of Life Assessed As an Index Score Using the EQ-5D (Data Cutoff 20 December 2013) | BL (n=202,219) | 0.6725 score on a scale |
| CT+BV Arm | Quality of Life Assessed As an Index Score Using the EQ-5D (Data Cutoff 20 December 2013) | Week 16/18 (n=80,118) | 0.6534 score on a scale |
| CT+BV Arm | Quality of Life Assessed As an Index Score Using the EQ-5D (Data Cutoff 20 December 2013) | Week 8/9 (n=127,135) | 0.6515 score on a scale |
Secondary
Quality of Life Assessed Using the EQ-5D Visual Analogue Scale (VAS) Scores (Data Cutoff 20 December 2013)
The participant was asked to rate their overall health on a 0-100 millimeter (mm) vertical scale, where the lowest endpoint=0 (labeled as worst imaginable health state) and the highest endpoint =100 (labeled as the best imaginable health state). The participant marked the line corresponding to their assessment and the distance from the bottom was measured in millimeters. A higher value indicated a better health state.
Time frame: Baseline, during second-line treatment at Weeks 8 and 16 (4-week cycles) or Weeks 9 and 18 (3-week cycles) and at second-line PD (up to approximately 3 years)
Population: ITT population; n=number of participants who completed the assessment at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| CT Arm | Quality of Life Assessed Using the EQ-5D Visual Analogue Scale (VAS) Scores (Data Cutoff 20 December 2013) | BL (n=200,212) | 66.5 mm |
| CT Arm | Quality of Life Assessed Using the EQ-5D Visual Analogue Scale (VAS) Scores (Data Cutoff 20 December 2013) | Week 8/9 (n=123,135) | 69.3 mm |
| CT Arm | Quality of Life Assessed Using the EQ-5D Visual Analogue Scale (VAS) Scores (Data Cutoff 20 December 2013) | Second-line PD (n=78,75) | 63.7 mm |
| CT Arm | Quality of Life Assessed Using the EQ-5D Visual Analogue Scale (VAS) Scores (Data Cutoff 20 December 2013) | Week 16/18 (n=75,119) | 67.3 mm |
| CT+BV Arm | Quality of Life Assessed Using the EQ-5D Visual Analogue Scale (VAS) Scores (Data Cutoff 20 December 2013) | Second-line PD (n=78,75) | 61.7 mm |
| CT+BV Arm | Quality of Life Assessed Using the EQ-5D Visual Analogue Scale (VAS) Scores (Data Cutoff 20 December 2013) | BL (n=200,212) | 63.4 mm |
| CT+BV Arm | Quality of Life Assessed Using the EQ-5D Visual Analogue Scale (VAS) Scores (Data Cutoff 20 December 2013) | Week 8/9 (n=123,135) | 66.5 mm |
| CT+BV Arm | Quality of Life Assessed Using the EQ-5D Visual Analogue Scale (VAS) Scores (Data Cutoff 20 December 2013) | Week 16/18 (n=75,119) | 66.4 mm |
Secondary
Second- and Third-Line PFS
The median time, in months, from randomization to second-line and third-line PFS event. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Time frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CT Arm | Second- and Third-Line PFS | 10.7 months |
| CT+BV Arm | Second- and Third-Line PFS | 12.8 months |
p-value: 0.134995% CI: [0.68, 1.05]Log Rank
p-value: 0.086395% CI: [0.68, 1.03]Log Rank
Secondary
Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013)
The median time, in months, from randomization to second-line PFS event according to the following baseline risk factors: hormone receptor negative, HER2 negative (triple negative), hormone receptor positive/HER-2 negative (HR-pos/HER-neg), first-line PFS less than (\<) 6 months, first-line PFS greater than or equal to (≥) 6 months, taxane chemotherapy (chemo), non-taxane chemo, vinorelbine chemo, LDH ≤ 1.5 upper limit of normal (ULN), LDH greater than (\>) 1.5 ULN, \< 65 years of age, ≥ 65 years of age, \< 70 years of age, ≥ 70 years of age, \< 3 metastatic organ sites, ≥ 3 metastatic organ sites, bevacizumab-free (B-free) interval ≤ 6 weeks, B-free \> 6 weeks, disease-free (D-free) interval ≤ 24 months, D-free \> 24 months, D-free ≤ 12 months, and D-free \> 12 months. Participants without second-line PD or death were censored at the date of last tumor assessment where non-progression was documented. PD: defined in Outcome measure 1. The 95% CI was estimated using Kaplan-Meier methodology.
Time frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 3 years
Population: ITT population. Here, Number of participants analyzed equals (=) participants evaluable for this outcome measure and number (n) = number of participants included in the analysis for the specified risk factor.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| CT Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | HR-neg (n=60,56) | 2.1 months |
| CT Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | HR-pos/HER-neg (n=187,191) | 4.7 months |
| CT Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | PFS <6 months (n=69,68) | 3.9 months |
| CT Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | PFS ≥6 months (n=178,179) | 4.6 months |
| CT Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | Taxane chemo (n=32,32) | 3.2 months |
| CT Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | Non-taxane chemo (n=191,188) | 4.4 months |
| CT Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | Vinorelbine chemo (n=24,27) | 2.4 months |
| CT Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | LDH ≤ 1.5 ULN (n=207,210) | 4.4 months |
| CT Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | LDH > 1.5 ULN (n=40,37) | 2.1 months |
| CT Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | < 65 years of age (n=196,183) | 4.2 months |
| CT Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | ≥ 65 years of age (n=51,64) | 4.2 months |
| CT Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | < 70 years of age (n=226,219) | 4.2 months |
| CT Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | ≥ 70 years of age (n=21,28) | 7.8 months |
| CT Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | < 3 metastatic organ sites (n=158,167) | 4.2 months |
| CT Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | ≥ 3 metastatic organ sites (n=88,80) | 4.0 months |
| CT Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | B-free ≤ 6 weeks (n=165,149) | 4.2 months |
| CT Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | B-free > 6 weeks (n=81,98) | 4.4 months |
| CT Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | D-free ≤ 24 months (n=58,53) | 2.8 months |
| CT Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | D-free > 24 months (n=138,156) | 4.9 months |
| CT Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | D-free ≤ 12 months (n=24,18) | 2.1 months |
| CT Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | D-free > 12 months (n=172,191) | 4.3 months |
| CT+BV Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | ≥ 65 years of age (n=51,64) | 6.7 months |
| CT+BV Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | HR-neg (n=60,56) | 4.9 months |
| CT+BV Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | D-free > 24 months (n=138,156) | 6.5 months |
| CT+BV Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | HR-pos/HER-neg (n=187,191) | 6.7 months |
| CT+BV Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | < 70 years of age (n=226,219) | 6.2 months |
| CT+BV Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | PFS <6 months (n=69,68) | 5.1 months |
| CT+BV Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | B-free > 6 weeks (n=81,98) | 7.6 months |
| CT+BV Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | PFS ≥6 months (n=178,179) | 6.4 months |
| CT+BV Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | ≥ 70 years of age (n=21,28) | 6.7 months |
| CT+BV Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | Taxane chemo (n=32,32) | 6.9 months |
| CT+BV Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | D-free > 12 months (n=172,191) | 6.3 months |
| CT+BV Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | Non-taxane chemo (n=191,188) | 6.0 months |
| CT+BV Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | < 3 metastatic organ sites (n=158,167) | 6.9 months |
| CT+BV Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | Vinorelbine chemo (n=24,27) | 6.5 months |
| CT+BV Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | D-free ≤ 24 months (n=58,53) | 5.8 months |
| CT+BV Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | LDH ≤ 1.5 ULN (n=207,210) | 6.3 months |
| CT+BV Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | ≥ 3 metastatic organ sites (n=88,80) | 4.7 months |
| CT+BV Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | LDH > 1.5 ULN (n=40,37) | 5.8 months |
| CT+BV Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | D-free ≤ 12 months (n=24,18) | 5.8 months |
| CT+BV Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | < 65 years of age (n=196,183) | 6.1 months |
| CT+BV Arm | Second-Line PFS by Baseline Risk Factor (Data Cutoff 20 December 2013) | B-free ≤ 6 weeks (n=165,149) | 5.8 months |
Comparison: Subgroup analysis: LDH ≤ 1.5 ULNp-value: 0.017195% CI: [0.62, 0.96]Log Rank
Comparison: Subgroup analysis: HR-negp-value: 0.008895% CI: [0.4, 0.88]Log Rank
Comparison: Subgroup analysis: HR-pos/HER-negp-value: 0.119695% CI: [0.67, 1.05]Log Rank
Comparison: Subgroup analysis: PFS \<6 monthsp-value: 0.01195% CI: [0.43, 0.9]Log Rank
Comparison: Subgroup analysis: PFS ≥6 monthsp-value: 0.081695% CI: [0.65, 1.03]Log Rank
Comparison: Subgroup analysis: taxane chemop-value: 0.039595% CI: [0.31, 0.98]Log Rank
Comparison: Subgroup analysis: non-taxane chemop-value: 0.138595% CI: [0.68, 1.06]Log Rank
Comparison: Subgroup analysis: vinorelbine chemop-value: 0.002995% CI: [0.22, 0.75]Log Rank
Comparison: Subgroup analysis: LDH \> 1.5 ULNp-value: 0.179795% CI: [0.46, 1.16]Log Rank
Comparison: Subgroup analysis: \< 65 years of agep-value: 0.022995% CI: [0.62, 0.97]Log Rank
Comparison: Subgroup analysis: ≥ 65 years of agep-value: 0.213995% CI: [0.51, 1.16]Log Rank
Comparison: Subgroup analysis: \< 70 years of agep-value: 0.002195% CI: [0.59, 0.89]Log Rank
Comparison: Subgroup analysis: ≥ 70 years of agep-value: 0.521695% CI: [0.64, 2.39]Log Rank
Comparison: Subgroup analysis: \< 3 metastatic organ sitesp-value: 0.014895% CI: [0.58, 0.94]Log Rank
Comparison: Subgroup analysis: ≥ 3 metastatic organ sitesp-value: 0.310295% CI: [0.61, 1.17]Log Rank
Comparison: Subgroup analysis: B-free ≤ 6 weeksp-value: 0.096795% CI: [0.64, 1.04]Log Rank
Comparison: Subgroup analysis: B-free \> 6 weeksp-value: 0.048995% CI: [0.51, 1]Log Rank
Comparison: Subgroup analysis: D-free ≤ 24 monthsp-value: 0.017695% CI: [0.41, 0.92]Log Rank
Comparison: Subgroup analysis: D-free \> 24 monthsp-value: 0.231895% CI: [0.66, 1.11]Log Rank
Comparison: Subgroup analysis: D-free ≤ 12 monthsp-value: 0.056895% CI: [0.26, 1.03]Log Rank
Comparison: Subgroup analysis: D-free \> 12 monthsp-value: 0.114395% CI: [0.66, 1.05]Log Rank
Secondary
Third-Line PFS
The median time, in months, from the first dose of third-line bevacizumab and/or chemotherapy to third-line PD or death due to any cause. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Time frame: First dose of third-line treatment until PD or death due to any cause (over a period of approximately 14 months)
Population: Third line ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CT Arm | Third-Line PFS | 2.9 months |
| CT+BV Arm | Third-Line PFS | 3.8 months |
p-value: 0.10895% CI: [0.59, 1.06]Log Rank
p-value: 0.062595% CI: [0.59, 1.02]Log Rank
Secondary
Time to Second- and Third-Line Tumor Progression
The median time, in months, from randomization to second- and third-line tumor progression. Second- and third-line tumor progression was defined as third-line PD according to RECIST v1.1 or death due to progression of disease. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without third-line PD or death were censored at the date of last tumor assessment where non-progression was documented.
Time frame: Baseline (≤28 days after randomization), every 8-9 weeks thereafter according to the standard of care of the treatment site until approximately 4 years
Population: ITT population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CT Arm | Time to Second- and Third-Line Tumor Progression | 11.2 months |
| CT+BV Arm | Time to Second- and Third-Line Tumor Progression | 13.3 months |
p-value: 0.074495% CI: [0.65, 1.02]Log Rank
p-value: 0.050395% CI: [0.66, 1]Log Rank