Breast Cancer
Conditions
Brief summary
This 2 arm study will compare the efficacy and safety of Avastin plus Herceptin/docetaxel, versus Herceptin/docetaxel alone, in patients with HER2 positive locally recurrent or metastatic breast cancer who have not received prior chemotherapy for their metastatic disease. Patients will be randomized 1:1 to receive either Avastin (15mg/kg iv q3weeks) + Herceptin (8mg/kg iv loading dose and 6mg/kg iv q3weeks maintenance) + docetaxel (100mg/m2 iv q3weeks) or Herceptin + docetaxel alone. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.
Interventions
DRUGbevacizumab [Avastin]
15mg/kg iv every 3 weeks
DRUGDocetaxel
100mg/m2 iv every 3 weeks
DRUGHerceptin
8mg/kg iv loading dose, followed by 6mg/kg iv every 3 weeks
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adult patients, \>=18 years of age; * HER2 positive breast cancer with locally recurrent or metastatic lesions; * eligible for chemotherapy; * baseline LVEF \>=50%.
Exclusion criteria
* previous chemotherapy for metastatic or locally recurrent breast cancer; * previous radiotherapy for metastatic breast cancer (except for metastatic bone pain relief); * other primary tumor within last 5 years, with the exception of basal or squamous skin cancer, or in situ cancer of the cervix; * clinically significant cardiovascular disease; * chronic daily treatment with aspirin (\>325mg/day) or clopidogrel (\>75mg/day).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression Free Survival (PFS) | Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years) | PFS was defined as the time from randomization to time of first documented disease progression (unequivocal progression of existing non-target lesions) or death, whichever occurred first as assessed by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0). Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started. Primary PFS variable was defined based on the investigators' assessments and the statistical conclusions on the primary efficacy endpoint were based on investigator assessed PFS. PFS was estimated using Kaplan-Meier methods. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR) in Participants With Measurable Disease at Baseline | Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years) | Best OR was assessed using RECIST v1.0 criteria. Participants were classified as responders if their best OR was either confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of the longest diameter \[LD\] of target lesions, taking as reference the baseline sum LD). Participants without any post-baseline assessments were regarded as non-responders. The 95% CI for the one sample binomial using Pearson-Clopper method. |
| Duration of Response (DR) | Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years) | DR was defined as the time when response (CR or PR per RECIST v1.0) was first documented to the date of disease progression per RECIST v1.0 (unequivocal progression of existing non-target lesions) or death. Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started. |
| Overall Survival (OS) | Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years) | OS was defined as the time from randomization to the date of death, regardless of the cause of death. OS was estimated using Kaplan-Meier methods. |
| Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Baseline, Cycles 3, 5, 11, and post progressive disease (PD; 14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years]) | FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB); each ranged from 0 (not at all) to 4 (very much). FACT-G ranged between 0-108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. FACT -B is used for assessment of HRQoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: 7 items for each physical, functional, social/family; all 3 ranged from 0-28, emotional (6 items) ranged from 0-24, and breast cancer subscale (9 items) ranged from 0-36. All single-item measures ranges from 0-144. High scale score represents a better QoL. |
| Change From Baseline for FACT-G and FACT-B | Baseline, Cycles 3, 5, 11, and post PD (14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years]) | FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB); each ranged from 0 (not at all) to 4 (very much). FACT-G ranged between 0-108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. FACT -B is used for assessment of HRQoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: 7 items for each physical, functional, social/family; all 3 ranged from 0-28, emotional (6 items) ranged from 0-24, and breast cancer subscale (9 items) ranged from 0-36. All single-item measures ranges from 0-144. High scale score represents a better QoL. |
| Time to Treatment Failure (TTF) | Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years) | TTF was defined as the time between randomization and date of disease progression (per RECIST v1.0; unequivocal progression of existing non-target lesions), death, or withdrawal of treatment due to adverse events, withdrawal of informed consent, insufficient therapeutic response, refusal of treatment/failure to co-operate, or failure to return, whichever occurred first. Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started. |
Countries
Argentina, Australia, Austria, Bosnia and Herzegovina, Brazil, Canada, Czechia, France, Italy, Mexico, Romania, Russia, Spain, Turkey (Türkiye), United Kingdom, Uruguay
Participant flow
Pre-assignment details
The participants were randomized 1:1 using a block design randomization procedure with stratification (for prior adjuvant/neo-adjuvant taxane, trastuzumab as part of adjuvant treatment versus no trastuzumab, estrogen/progesterone receptor hormone receptor status and measurable disease) to avoid an imbalance of important prognostic factors.
Participants by arm
| Arm | Count |
|---|---|
| Trastuzumab + Docetaxel Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent, and for a minimum of 6 cycles, respectively. | 208 |
| Trastuzumab + Bevacizumab + Docetaxel Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m\^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m\^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant's consent. | 216 |
| Total | 424 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Alive in follow-up | 88 | 84 |
| Overall Study | Alive on treatment | 29 | 33 |
| Overall Study | Death | 78 | 81 |
| Overall Study | Lost to Follow-up | 13 | 18 |
Baseline characteristics
| Characteristic | Trastuzumab + Docetaxel | Trastuzumab + Bevacizumab + Docetaxel | Total |
|---|---|---|---|
| Age, Continuous | 54.0 years STANDARD_DEVIATION 11.71 | 53.5 years STANDARD_DEVIATION 10.9 | 53.7 years STANDARD_DEVIATION 11.29 |
| Sex: Female, Male Female | 208 Participants | 216 Participants | 424 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 | 198 / 206 | 202 / 215 |
| serious Total, serious adverse events | 63 / 206 | 72 / 215 |
Outcome results
Primary
Progression Free Survival (PFS)
PFS was defined as the time from randomization to time of first documented disease progression (unequivocal progression of existing non-target lesions) or death, whichever occurred first as assessed by Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0). Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started. Primary PFS variable was defined based on the investigators' assessments and the statistical conclusions on the primary efficacy endpoint were based on investigator assessed PFS. PFS was estimated using Kaplan-Meier methods.
Time frame: Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
Population: ITT Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Trastuzumab + Docetaxel | Progression Free Survival (PFS) | 13.7 months |
| Trastuzumab + Bevacizumab + Docetaxel | Progression Free Survival (PFS) | 16.5 months |
p-value: 0.077595% CI: [0.65, 1.02]Log Rank (unstratified)
Secondary
Change From Baseline for FACT-G and FACT-B
FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB); each ranged from 0 (not at all) to 4 (very much). FACT-G ranged between 0-108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. FACT -B is used for assessment of HRQoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: 7 items for each physical, functional, social/family; all 3 ranged from 0-28, emotional (6 items) ranged from 0-24, and breast cancer subscale (9 items) ranged from 0-36. All single-item measures ranges from 0-144. High scale score represents a better QoL.
Time frame: Baseline, Cycles 3, 5, 11, and post PD (14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years])
Population: ITT Population; n (number) = number of participants assessed for the given parameter at the specified visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Physical Well-Being: Post PD (n=33, 39) | -1.25 units on a scale | Standard Deviation 7.61 |
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Physical Well-Being: Cycle 3 (n=145,173) | -1.01 units on a scale | Standard Deviation 7.54 |
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Social Well-Being: Cycle 3 (n=145,173) | 0.05 units on a scale | Standard Deviation 7.83 |
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Emotional Well-Being: Cycle 3 (n=145,173) | 1.52 units on a scale | Standard Deviation 6.49 |
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Functional Well-Being: Cycle 3 (n=145, 173) | -0.91 units on a scale | Standard Deviation 7.9 |
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Total FACT-G Score: Cycle 3 (n=145,173) | -0.36 units on a scale | Standard Deviation 22.25 |
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Breast Specific: Cycle 3 (n=145,173) | 0.61 units on a scale | Standard Deviation 8.65 |
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Total FACT-B Score: Cycle 3 (n=145,173) | 0.29 units on a scale | Standard Deviation 27.63 |
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Trial Outcome Index: Cycle 3 (n=145,173) | -1.50 units on a scale | Standard Deviation 18.99 |
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Physical Well-Being: Cycle 5 (n=139, 166) | -1.69 units on a scale | Standard Deviation 7.5 |
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Social Well-Being: Cycle 5 (n=139, 166) | -1.23 units on a scale | Standard Deviation 7.79 |
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Emotional Well-Being: Cycle 5 (n=139, 166) | 1.09 units on a scale | Standard Deviation 6.65 |
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Functional Well-Being: Cycle 5 (n=139, 166) | -1.53 units on a scale | Standard Deviation 7.98 |
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Total FACT-G Score: Cycle 5 (n=139, 166) | -3.53 units on a scale | Standard Deviation 22.4 |
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Breast Specific: Cycle 5 (n=139, 166) | -0.03 units on a scale | Standard Deviation 8.68 |
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Total FACT-B Score: Cycle 5 (n=139, 166) | -3.55 units on a scale | Standard Deviation 27.82 |
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Trial Outcome Index: Cycle 5 (n=139, 166) | -3.55 units on a scale | Standard Deviation 19.19 |
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Physical Well-Being: Cycle 11 (n=100, 133) | 0.51 units on a scale | Standard Deviation 7.32 |
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Social Well-Being: Cycle 11 (n=100, 133) | -0.89 units on a scale | Standard Deviation 8.13 |
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Emotional Well-Being: Cycle 11 (n=100, 133) | 1.00 units on a scale | Standard Deviation 6.69 |
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Functional Well-Being: Cycle 11 (n=100, 133) | -0.09 units on a scale | Standard Deviation 7.79 |
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Total FACT-G Score: Cycle 11 (n=100, 133) | -0.05 units on a scale | Standard Deviation 22.54 |
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Breast Specific: Cycle 11 (n=100, 133) | -0.38 units on a scale | Standard Deviation 8.49 |
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Trial Outcome Index: Cycle 11 (n=100, 133) | -0.35 units on a scale | Standard Deviation 18.46 |
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Total FACT-B Score: Cycle 11 (n=100, 133) | -0.41 units on a scale | Standard Deviation 27.67 |
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Social Well-Being: Post PD (n=33, 39) | -1.58 units on a scale | Standard Deviation 8.03 |
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Emotional Well-Being: Post PD (n=33, 39) | -0.20 units on a scale | Standard Deviation 6.92 |
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Functional Well-Being: Post PD (n=33, 39) | -2.22 units on a scale | Standard Deviation 8.06 |
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Total FACT-G Score: Post PD (n=33, 39) | -5.46 units on a scale | Standard Deviation 21.85 |
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Breast Specific: Post PD (n=33, 39) | 1.22 units on a scale | Standard Deviation 7.84 |
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Total FACT-B Score: Post PD (n=33, 39) | -4.23 units on a scale | Standard Deviation 26.37 |
| Trastuzumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Trial Outcome Index: Post PD (n=33, 39) | -2.57 units on a scale | Standard Deviation 17.92 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Physical Well-Being: Cycle 5 (n=139, 166) | -1.80 units on a scale | Standard Deviation 6.82 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Physical Well-Being: Cycle 11 (n=100, 133) | 0.09 units on a scale | Standard Deviation 6.8 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Physical Well-Being: Cycle 3 (n=145,173) | -1.51 units on a scale | Standard Deviation 7.16 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Social Well-Being: Post PD (n=33, 39) | -1.19 units on a scale | Standard Deviation 7.48 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Social Well-Being: Cycle 3 (n=145,173) | 0.32 units on a scale | Standard Deviation 7.93 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Social Well-Being: Cycle 11 (n=100, 133) | -0.10 units on a scale | Standard Deviation 7.58 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Emotional Well-Being: Cycle 3 (n=145,173) | 1.16 units on a scale | Standard Deviation 6.22 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Breast Specific: Post PD (n=33, 39) | 0.03 units on a scale | Standard Deviation 7.79 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Functional Well-Being: Cycle 3 (n=145, 173) | -0.16 units on a scale | Standard Deviation 7.63 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Emotional Well-Being: Cycle 11 (n=100, 133) | 1.92 units on a scale | Standard Deviation 5.78 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Total FACT-G Score: Cycle 3 (n=145,173) | -0.44 units on a scale | Standard Deviation 20.4 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Emotional Well-Being: Post PD (n=33, 39) | -0.78 units on a scale | Standard Deviation 6.42 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Breast Specific: Cycle 3 (n=145,173) | 0.34 units on a scale | Standard Deviation 7.92 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Functional Well-Being: Cycle 11 (n=100, 133) | 0.62 units on a scale | Standard Deviation 7.43 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Total FACT-B Score: Cycle 3 (n=145,173) | -0.24 units on a scale | Standard Deviation 25.12 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Trial Outcome Index: Post PD (n=33, 39) | -2.38 units on a scale | Standard Deviation 17.7 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Trial Outcome Index: Cycle 3 (n=145,173) | -1.52 units on a scale | Standard Deviation 17.75 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Total FACT-G Score: Cycle 11 (n=100, 133) | 2.06 units on a scale | Standard Deviation 19.85 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Functional Well-Being: Post PD (n=33, 39) | -1.28 units on a scale | Standard Deviation 7.59 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Social Well-Being: Cycle 5 (n=139, 166) | -0.20 units on a scale | Standard Deviation 7.58 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Breast Specific: Cycle 11 (n=100, 133) | 0.96 units on a scale | Standard Deviation 7.64 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Emotional Well-Being: Cycle 5 (n=139, 166) | 1.53 units on a scale | Standard Deviation 6.18 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Total FACT-B Score: Cycle 11 (n=100, 133) | 2.97 units on a scale | Standard Deviation 24.53 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Functional Well-Being: Cycle 5 (n=139, 166) | -0.58 units on a scale | Standard Deviation 7.33 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Total FACT-B Score: Post PD (n=33, 39) | -4.55 units on a scale | Standard Deviation 25.59 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Total FACT-G Score: Cycle 5 (n=139, 166) | -1.28 units on a scale | Standard Deviation 19.14 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Trial Outcome Index: Cycle 11 (n=100, 133) | 1.49 units on a scale | Standard Deviation 17.26 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Breast Specific: Cycle 5 (n=139, 166) | 0.31 units on a scale | Standard Deviation 7.63 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Total FACT-G Score: Post PD (n=33, 39) | -4.44 units on a scale | Standard Deviation 20.92 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Total FACT-B Score: Cycle 5 (n=139, 166) | -1.10 units on a scale | Standard Deviation 23.62 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Physical Well-Being: Post PD (n=33, 39) | -1.12 units on a scale | Standard Deviation 7.39 |
| Trastuzumab + Bevacizumab + Docetaxel | Change From Baseline for FACT-G and FACT-B | Trial Outcome Index: Cycle 5 (n=139, 166) | -2.26 units on a scale | Standard Deviation 16.74 |
Secondary
Duration of Response (DR)
DR was defined as the time when response (CR or PR per RECIST v1.0) was first documented to the date of disease progression per RECIST v1.0 (unequivocal progression of existing non-target lesions) or death. Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started.
Time frame: Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
Population: ITT Population: only participants with a best OR of CR or PR were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Trastuzumab + Docetaxel | Duration of Response (DR) | 11.4 months |
| Trastuzumab + Bevacizumab + Docetaxel | Duration of Response (DR) | 14.6 months |
95% CI: [0.56, 0.98]
Secondary
Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores
FACT-G is core questionnaire of Functional Assessment of Chronic Illness Therapy (FACIT) measurement system to evaluate quality of life (QoL) in cancer population. FACT-G consisted of 27 questions grouped in 4 domains of general Health-Related QoL (HRQoL): Physical Well-being (PWB), Social/Family Well-Being (SWB), Emotional Well-Being (EWB) and Functional Well-Being (FWB); each ranged from 0 (not at all) to 4 (very much). FACT-G ranged between 0-108. Since questions could be reversed coded, as appropriate, before calculating FACT-G, 0 and 108 could be considered worst and best health states. FACT -B is used for assessment of HRQoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: 7 items for each physical, functional, social/family; all 3 ranged from 0-28, emotional (6 items) ranged from 0-24, and breast cancer subscale (9 items) ranged from 0-36. All single-item measures ranges from 0-144. High scale score represents a better QoL.
Time frame: Baseline, Cycles 3, 5, 11, and post progressive disease (PD; 14 to 28 days after disease progression [up to the clinical cutoff of 30 June 2011, up to 4.75 years])
Population: ITT Population; n (number) = number of participants assessed for the given parameter at the specified visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Total FACT-G Score: Baseline (n=173,189) | 73.30 units on a scale | Standard Deviation 16.6 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Physical Well-Being: Cycle 3 (n=145,173) | 20.19 units on a scale | Standard Deviation 4.89 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Social Well-Being: Cycle 3 (n=145,173) | 20.64 units on a scale | Standard Deviation 5.32 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Emotional Well-Being: Cycle 5 (n=139, 166) | 16.05 units on a scale | Standard Deviation 4.44 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Functional Well-Being: Cycle 5 (n=139, 166) | 14.81 units on a scale | Standard Deviation 5.45 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Breast Specific: Cycle 5 (n=139, 166) | 21.65 units on a scale | Standard Deviation 5.83 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Total FACT-B Score: Cycle 5 (n=139, 166) | 91.43 units on a scale | Standard Deviation 18.81 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Trial Outcome Index: Cycle 5 (n=139, 166) | 55.99 units on a scale | Standard Deviation 13.09 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Functional Well-Being: Post PD (n=33, 39) | 14.13 units on a scale | Standard Deviation 5.57 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Total FACT-G Score: Post PD (n=33, 39) | 67.84 units on a scale | Standard Deviation 14.21 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Breast Specific: Post PD (n=33, 39) | 22.90 units on a scale | Standard Deviation 4.48 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Total FACT-B Score: Post PD (n=33, 39) | 90.74 units on a scale | Standard Deviation 16.59 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Trial Outcome Index: Post PD (n=33, 39) | 56.97 units on a scale | Standard Deviation 11.16 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Physical Well-Being: Baseline (n=173,189) | 21.20 units on a scale | Standard Deviation 5.74 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Social Well-Being: Baseline (n=173,189) | 20.59 units on a scale | Standard Deviation 5.75 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Emotional Well-Being: Baseline (n=173,189) | 14.95 units on a scale | Standard Deviation 4.95 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Functional Well-Being: Baseline (n=173,189) | 16.34 units on a scale | Standard Deviation 5.83 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Breast Specific: Baseline (n=173,189) | 21.67 units on a scale | Standard Deviation 6.43 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Total FACT-B Score: Baseline (n=173,189) | 94.97 units on a scale | Standard Deviation 20.5 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Trial Outcome Index: Baseline (n=173,189) | 59.54 units on a scale | Standard Deviation 14.03 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Emotional Well-Being: Cycle 3 (n=145,173) | 16.47 units on a scale | Standard Deviation 4.19 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Functional Well-Being: Cycle 3 (n=145, 173) | 15.43 units on a scale | Standard Deviation 5.33 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Total FACT-G Score: Cycle 3 (n=145,173) | 72.94 units on a scale | Standard Deviation 14.81 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Breast Specific: Cycle 3 (n=145,173) | 22.29 units on a scale | Standard Deviation 5.78 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Total FACT-B Score: Cycle 3 (n=145,173) | 95.26 units on a scale | Standard Deviation 18.52 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Trial Outcome Index: Cycle 3 (n=145,173) | 58.04 units on a scale | Standard Deviation 12.8 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Physical Well-Being: Cycle 5 (n=139, 166) | 19.51 units on a scale | Standard Deviation 4.83 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Social Well-Being: Cycle 5 (n=139, 166) | 19.36 units on a scale | Standard Deviation 5.26 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Total FACT-G Score: Cycle 5 (n=139, 166) | 69.78 units on a scale | Standard Deviation 15.04 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Social Well-Being: Cycle 11 (n=100, 133) | 19.71 units on a scale | Standard Deviation 5.74 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Physical Well-Being: Cycle 11 (n=100, 133) | 21.71 units on a scale | Standard Deviation 4.54 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Emotional Well-Being: Cycle 11 (n=100, 133) | 15.96 units on a scale | Standard Deviation 4.5 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Functional Well-Being: Cycle 11 (n=100, 133) | 16.25 units on a scale | Standard Deviation 5.16 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Total FACT-G Score: Cycle 11 (n=100, 133) | 73.26 units on a scale | Standard Deviation 15.24 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Breast Specific: Cycle 11 (n=100, 133) | 21.29 units on a scale | Standard Deviation 5.55 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Total FACT-B Score: Cycle 11 (n=100, 133) | 94.57 units on a scale | Standard Deviation 18.58 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Trial Outcome Index: Cycle 11 (n=100, 133) | 59.19 units on a scale | Standard Deviation 12 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Physical Well-Being: Post PD (n=33, 39) | 19.94 units on a scale | Standard Deviation 4.99 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Social Well-Being: Post PD (n=33, 39) | 19.02 units on a scale | Standard Deviation 5.61 |
| Trastuzumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Emotional Well-Being: Post PD (n=33, 39) | 14.76 units on a scale | Standard Deviation 4.83 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Social Well-Being: Cycle 3 (n=145,173) | 21.19 units on a scale | Standard Deviation 5.44 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Total FACT-B Score: Cycle 5 (n=139, 166) | 96.36 units on a scale | Standard Deviation 15.63 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Emotional Well-Being: Cycle 3 (n=145,173) | 16.70 units on a scale | Standard Deviation 4.36 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Trial Outcome Index: Cycle 11 (n=100, 133) | 62.34 units on a scale | Standard Deviation 11.79 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Emotional Well-Being: Cycle 5 (n=139, 166) | 17.07 units on a scale | Standard Deviation 4.3 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Functional Well-Being: Cycle 3 (n=145, 173) | 16.20 units on a scale | Standard Deviation 5.22 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Total FACT-G Score: Cycle 5 (n=139, 166) | 73.21 units on a scale | Standard Deviation 12.49 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Breast Specific: Cycle 11 (n=100, 133) | 23.80 units on a scale | Standard Deviation 4.92 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Total FACT-G Score: Cycle 3 (n=145,173) | 74.05 units on a scale | Standard Deviation 14.35 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Social Well-Being: Cycle 11 (n=100, 133) | 20.78 units on a scale | Standard Deviation 4.92 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Trial Outcome Index: Cycle 5 (n=139, 166) | 58.59 units on a scale | Standard Deviation 11.01 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Physical Well-Being: Cycle 11 (n=100, 133) | 21.56 units on a scale | Standard Deviation 4.53 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Total FACT-G Score: Cycle 11 (n=100, 133) | 76.55 units on a scale | Standard Deviation 13.56 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Emotional Well-Being: Post PD (n=33, 39) | 14.77 units on a scale | Standard Deviation 4.64 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Breast Specific: Cycle 3 (n=145,173) | 23.17 units on a scale | Standard Deviation 5.34 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Functional Well-Being: Post PD (n=33, 39) | 15.08 units on a scale | Standard Deviation 5.16 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Social Well-Being: Post PD (n=33, 39) | 19.68 units on a scale | Standard Deviation 4.77 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Total FACT-G Score: Post PD (n=33, 39) | 70.04 units on a scale | Standard Deviation 15.08 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Total FACT-B Score: Cycle 3 (n=145,173) | 97.23 units on a scale | Standard Deviation 17.81 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Breast Specific: Post PD (n=33, 39) | 22.87 units on a scale | Standard Deviation 5.14 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Emotional Well-Being: Cycle 11 (n=100, 133) | 17.46 units on a scale | Standard Deviation 3.7 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Total FACT-B Score: Post PD (n=33, 39) | 92.92 units on a scale | Standard Deviation 18.47 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Trial Outcome Index: Cycle 3 (n=145,173) | 59.33 units on a scale | Standard Deviation 12.49 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Trial Outcome Index: Post PD (n=33, 39) | 58.47 units on a scale | Standard Deviation 12.43 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Total FACT-B Score: Cycle 11 (n=100, 133) | 100.43 units on a scale | Standard Deviation 16.97 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Physical Well-Being: Baseline (n=173,189) | 21.47 units on a scale | Standard Deviation 5.07 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Physical Well-Being: Cycle 5 (n=139, 166) | 19.67 units on a scale | Standard Deviation 4.56 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Social Well-Being: Baseline (n=173,189) | 20.88 units on a scale | Standard Deviation 5.77 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Functional Well-Being: Cycle 11 (n=100, 133) | 16.98 units on a scale | Standard Deviation 4.92 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Emotional Well-Being: Baseline (n=173,189) | 15.54 units on a scale | Standard Deviation 4.44 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Social Well-Being: Cycle 5 (n=139, 166) | 20.68 units on a scale | Standard Deviation 4.92 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Functional Well-Being: Baseline (n=173,189) | 16.36 units on a scale | Standard Deviation 5.57 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Total FACT-G Score: Baseline (n=173,189) | 74.49 units on a scale | Standard Deviation 14.5 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Functional Well-Being: Cycle 5 (n=139, 166) | 15.78 units on a scale | Standard Deviation 4.77 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Breast Specific: Baseline (n=173,189) | 22.84 units on a scale | Standard Deviation 5.85 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Physical Well-Being: Post PD (n=33, 39) | 20.35 units on a scale | Standard Deviation 5.37 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Total FACT-B Score: Baseline (n=173,189) | 97.46 units on a scale | Standard Deviation 17.71 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Breast Specific: Cycle 5 (n=139, 166) | 23.15 units on a scale | Standard Deviation 4.9 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Trial Outcome Index: Baseline (n=173,189) | 60.85 units on a scale | Standard Deviation 12.61 |
| Trastuzumab + Bevacizumab + Docetaxel | Functional Assessment of Cancer Therapy - Generic (FACT-G) and Functional Assessment of Cancer Therapy - Breast (FACT-B) Subscale Scores | Physical Well-Being: Cycle 3 (n=145,173) | 19.96 units on a scale | Standard Deviation 5.05 |
Secondary
Overall Survival (OS)
OS was defined as the time from randomization to the date of death, regardless of the cause of death. OS was estimated using Kaplan-Meier methods.
Time frame: Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
Population: ITT Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Trastuzumab + Docetaxel | Overall Survival (OS) | 38.3 months |
| Trastuzumab + Bevacizumab + Docetaxel | Overall Survival (OS) | 38.5 months |
p-value: 0.954395% CI: [0.74, 1.38]Log Rank
Secondary
Percentage of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR) in Participants With Measurable Disease at Baseline
Best OR was assessed using RECIST v1.0 criteria. Participants were classified as responders if their best OR was either confirmed CR (disappearance of all target lesions) or confirmed PR (at least a 30% decrease in the sum of the longest diameter \[LD\] of target lesions, taking as reference the baseline sum LD). Participants without any post-baseline assessments were regarded as non-responders. The 95% CI for the one sample binomial using Pearson-Clopper method.
Time frame: Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
Population: ITT Population; only participants with measurable disease at baseline were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Trastuzumab + Docetaxel | Percentage of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR) in Participants With Measurable Disease at Baseline | 69.9 percentage of participants |
| Trastuzumab + Bevacizumab + Docetaxel | Percentage of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Partial Response (PR) in Participants With Measurable Disease at Baseline | 74.3 percentage of participants |
p-value: 0.349295% CI: [-5.2, 14]Chi-squared
Secondary
Time to Treatment Failure (TTF)
TTF was defined as the time between randomization and date of disease progression (per RECIST v1.0; unequivocal progression of existing non-target lesions), death, or withdrawal of treatment due to adverse events, withdrawal of informed consent, insufficient therapeutic response, refusal of treatment/failure to co-operate, or failure to return, whichever occurred first. Progressive disease is defined using RECIST v1.0 as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started.
Time frame: Every 9 weeks up to Week 36, thereafter every 12 weeks until disease progression (up to the clinical cutoff of 30 June 2011, up to 4.75 years)
Population: ITT Population
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Trastuzumab + Docetaxel | Time to Treatment Failure (TTF) | 7.7 months |
| Trastuzumab + Bevacizumab + Docetaxel | Time to Treatment Failure (TTF) | 9.8 months |
p-value: 0.539295% CI: [0.76, 1.15]Log Rank