Breast Cancer
Conditions
Brief summary
This 3 arm study will assess the tolerability, safety and efficacy of 3 neoadjuvant treatment regimens in participants with locally advanced, inflammatory or early stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Before surgery, participants will be randomized to receive either A) 6 cycles of pertuzumab plus trastuzumab (Herceptin), with 5-fluorouracil/epirubicin/cyclophosphamide (FEC) for cycles 1-3 and docetaxel for cycles 4-6, or B) FEC for cycles 1-3 followed by pertuzumab plus trastuzumab with docetaxel for cycles 4-6, or C) 6 cycles of pertuzumab plus trastuzumab with docetaxel and carboplatin. Pertuzumab will be administered at a loading dose of 840 mg intravenously (iv), then 420 mg iv 3-weekly, trastuzumab at a loading dose of 8 mg/kg iv, then 6 mg/kg iv 3-weekly, docetaxel at 75 mg/m\^2 iv, increased to 100 mg/m\^2 iv 3-weekly, and FEC and carboplatin iv 3-weekly at standard doses. Following surgery participants will receive trastuzumab 6 mg/kg iv 3-weekly for a total of 1 year, as well as adequate chemo-, radio- and hormone therapy. Anticipated time on study treatment is 4-12 months, and target sample size is 200-300.
Interventions
DRUGPertuzumab
840 mg loading dose intravenously (IV), then 420 mg IV 3-weekly.
DRUGTrastuzumab
8 mg/kg loading dose IV, then 6 mg/kg every 3 weeks.
DRUGFEC
5-fluorouracil 500 mg/m\^2, epirubicin 100 mg/m\^2 and cyclophosphamide 600 mg/m\^2.
DRUGDocetaxel
75 mg/m\^2 for the first dose; 100 mg/m\^2 if no dose limiting toxicity occurs.
DRUGTCH
Trastuzumab followed by carboplatin at target area under the plasma concentration-time curve (AUC) 6 and docetaxel at a starting dose of 75 mg/m\^2. All treatments were given every three weeks by the IV route.
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 participants, age \>/=18 years * advanced, inflammatory or early stage unilateral invasive breast cancer * HER2-positive breast cancer * baseline left ventricular ejection fraction (LVEF) \>/=55%
Exclusion criteria
* metastatic disease (Stage IV) or bilateral breast cancer * previous anticancer therapy or radiotherapy for any malignancy * other malignancy, except for carcinoma in situ of the cervix, or basal cell carcinoma * clinically relevant cardiovascular disease * current chronic treatment with corticosteroids of \>10mg methylprednisolone or equivalent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety: Percentage of Participants With Symptomatic Cardiac Events as Assessed by the Investigator | From baseline up to approximately 3.5 years | Left ventricular systolic dysfunction (LVSD) as assessed by the Investigator, including Grade 3, 4 or 5 symptomatic LVSD with symptomatic cardiac events. |
| Safety: Percentage of Participants With Left Ventricular Ejection Fraction (LVEF) Decline During Pre-operative (Neoadjuvant) Period | From baseline up to approximately 18 weeks | Percentage of participants with LVEF measures decline of ≥ 10% from baseline and to a value of \<50% during the pre-operative (neoadjuvant) period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy: Time to Clinical Response | Up to 18 weeks | Time to clinical response is defined as the time from the date of first dose received to the first date of assessment of clinical response. Clinical response is defined as a response of CR or PR at any time pre-surgery. Per RECIST v1.0 for target lesions and assessed by mammogram or MRI and CBE, CR is disappearance of all target lesions; PR is \>=30% decrease in the sum of the longest diameter of target lesions. |
| Efficacy: Percentage of Participants Achieving Breast Conserving Surgery | At approximately 18 weeks | This is the percentage of participants who achieved breast conserving surgery out of the intent-to-treat population without inflammatory breast cancer, as these participants received mastectomy irrespective of their response to neoadjuvant (pre-operative) treatment. |
| Efficacy: Percentage of Participants Without an Overall Survival (OS) Event | From baseline to end of study up to 5 years | Overall survival (OS) was defined as the time from randomization to the date of death from any cause. Participants who were alive or lost to follow-up were censored at the last known alive date. Participants with no post-baseline information were censored at the date of randomization plus one day. |
| Efficacy: Percentage of Participants Without a Disease-Free Survival (DFS) Event | From baseline to end of study up to 5 years | The DFS was defined as the time from the first date of no disease (i.e., date of surgery) to the first documentation of progressive disease (PD) or death. PD was assessed using RECIST v1.0 and MRI and CBE. It was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions. Any evidence of contralateral disease in situ was not considered as PD. Participants who were withdrawn from the study without documented PD were censored at the date of the last assessment when the participant was known to be disease-free. |
| Efficacy: Percentage of Participants With Complete Pathological Response (pCR) | At surgery, after 18 weeks (6 cycles) of treatment | pCR is defined as the absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. pCR is evaluated after 6 cycles of treatment and surgery or following withdrawal from the study whichever occurs sooner. |
| Safety: Percentage of Participants With Cardiac Symptoms Associated With Symptomatic Left Ventricular Systolic Dysfunction (LVSD) | From Baseline to end of Neoadjuvant Period (up to 18 weeks), Adjuvant Period (up to 1.5 years), Follow-up Period (up to 3.5 years) | Percentage of participants with signs or symptoms of cardiac events. |
| Safety: Percentage of Participants With Asymptomatic Left Ventricular Ejection Fraction (LVEF) Events | From baseline to end of Neoadjuvant Period (up to 18 weeks), Adjuvant Period (up to 1.5 years), Follow-up Period (up to 3.5 years) | Percentage of participants with LVEF events without signs or symptoms of cardiac events. |
| Safety: Maximum Decrease in Left Ventricular Ejection Fraction (LVEF) Measures | From baseline up to approximately 3.5 years | Maximum decrease in LVEF measures is the change from baseline at worst treatment value. LVEF is measured as percentage. |
| Efficacy: Percentage of Participants Without a Progression-Free Survival (PFS) Event | From baseline to end of study up to 5 years | Progression-free survival was defined as the time from the date of randomization to the first documentation of PD or death from any cause, whichever occurred first. PD was assessed using RECIST v1.0 and MRI and CBE. It was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions. Participants who were withdrawn from the study without documented PD were censored at the date of the last assessment when the participant was known to be free from PD. Participants without post-baseline assessments but known to be alive were censored at the time of randomization plus one day. |
| Efficacy: Clinical Response Rate | During each 3-week cycle of 6 total cycles: up to 18 weeks | Tumor response is defined as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) and is identified as per local practice. Clinical response rate is defined as the percentage of participants who achieve a response of CR or PR at any time pre-surgery. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by mammogram or magnetic resonance imaging (MRI) and clinical breast examination (CBE), CR is disappearance of all target lesions; PR is \>=30% decrease in the sum of the longest diameter of target lesions. |
Countries
Bosnia and Herzegovina, Brazil, Canada, Croatia, Germany, Greece, Italy, Mexico, New Zealand, Portugal, Romania, Serbia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, The Bahamas, United Kingdom
Participant flow
Recruitment details
This study included 3 periods: Neoadjuvant (pre-operative) period and surgery, adjuvant (post-operative) period and post-treatment follow-up period.
Participants by arm
| Arm | Count |
|---|---|
| T+P Concomitant Anthracycline-based Chemotherapy 5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery. | 73 |
| T+P Sequential Anthracycline-based Chemotherapy FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery. | 75 |
| T+P Concomitant Non-Anthracycline Chemotherapy Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery. | 77 |
| Total | 225 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 5 | 7 | 10 |
| Overall Study | Failure to Return | 2 | 1 | 0 |
| Overall Study | Other | 1 | 0 | 1 |
| Overall Study | Recurrence of Disease | 0 | 1 | 0 |
| Overall Study | Refused Treatment | 4 | 3 | 5 |
| Overall Study | Violation of Selection Criteria at Entry | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | T+P Concomitant Anthracycline-based Chemotherapy | T+P Sequential Anthracycline-based Chemotherapy | T+P Concomitant Non-Anthracycline Chemotherapy | Total |
|---|---|---|---|---|
| Age, Continuous | 49.6 years STANDARD_DEVIATION 11.41 | 50.5 years STANDARD_DEVIATION 10.7 | 50.6 years STANDARD_DEVIATION 10.58 | 50.6 years STANDARD_DEVIATION 10.86 |
| Gender Female | 73 Participants | 75 Participants | 77 Participants | 225 Participants |
| Gender Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 72 / 72 | 73 / 75 | 76 / 76 |
| serious Total, serious adverse events | 23 / 72 | 18 / 75 | 31 / 76 |
Outcome results
Primary
Safety: Percentage of Participants With Left Ventricular Ejection Fraction (LVEF) Decline During Pre-operative (Neoadjuvant) Period
Percentage of participants with LVEF measures decline of ≥ 10% from baseline and to a value of \<50% during the pre-operative (neoadjuvant) period.
Time frame: From baseline up to approximately 18 weeks
Population: Safety population included all participants who were randomized and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| T+P Concomitant Anthracycline-based Chemotherapy | Safety: Percentage of Participants With Left Ventricular Ejection Fraction (LVEF) Decline During Pre-operative (Neoadjuvant) Period | 5.6 percentage of participants |
| T+P Sequential Anthracycline-based Chemotherapy | Safety: Percentage of Participants With Left Ventricular Ejection Fraction (LVEF) Decline During Pre-operative (Neoadjuvant) Period | 5.3 percentage of participants |
| T+P Concomitant Non-Anthracycline Chemotherapy | Safety: Percentage of Participants With Left Ventricular Ejection Fraction (LVEF) Decline During Pre-operative (Neoadjuvant) Period | 3.9 percentage of participants |
Primary
Safety: Percentage of Participants With Symptomatic Cardiac Events as Assessed by the Investigator
Left ventricular systolic dysfunction (LVSD) as assessed by the Investigator, including Grade 3, 4 or 5 symptomatic LVSD with symptomatic cardiac events.
Time frame: From baseline up to approximately 3.5 years
Population: Safety population included all participants who were randomized and received study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| T+P Concomitant Anthracycline-based Chemotherapy | Safety: Percentage of Participants With Symptomatic Cardiac Events as Assessed by the Investigator | 0 percentage of participants |
| T+P Sequential Anthracycline-based Chemotherapy | Safety: Percentage of Participants With Symptomatic Cardiac Events as Assessed by the Investigator | 2.7 percentage of participants |
| T+P Concomitant Non-Anthracycline Chemotherapy | Safety: Percentage of Participants With Symptomatic Cardiac Events as Assessed by the Investigator | 1.3 percentage of participants |
Secondary
Efficacy: Clinical Response Rate
Tumor response is defined as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) and is identified as per local practice. Clinical response rate is defined as the percentage of participants who achieve a response of CR or PR at any time pre-surgery. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by mammogram or magnetic resonance imaging (MRI) and clinical breast examination (CBE), CR is disappearance of all target lesions; PR is \>=30% decrease in the sum of the longest diameter of target lesions.
Time frame: During each 3-week cycle of 6 total cycles: up to 18 weeks
Population: ITT population included all participants who were randomized to treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| T+P Concomitant Anthracycline-based Chemotherapy | Efficacy: Clinical Response Rate | 91.8 percentage of participants |
| T+P Sequential Anthracycline-based Chemotherapy | Efficacy: Clinical Response Rate | 94.7 percentage of participants |
| T+P Concomitant Non-Anthracycline Chemotherapy | Efficacy: Clinical Response Rate | 89.6 percentage of participants |
Secondary
Efficacy: Percentage of Participants Achieving Breast Conserving Surgery
This is the percentage of participants who achieved breast conserving surgery out of the intent-to-treat population without inflammatory breast cancer, as these participants received mastectomy irrespective of their response to neoadjuvant (pre-operative) treatment.
Time frame: At approximately 18 weeks
Population: Number of participants analyzed represents the participants with T2-3 tumors for whom mastectomy was planned.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| T+P Concomitant Anthracycline-based Chemotherapy | Efficacy: Percentage of Participants Achieving Breast Conserving Surgery | 21.7 percentage of participants |
| T+P Sequential Anthracycline-based Chemotherapy | Efficacy: Percentage of Participants Achieving Breast Conserving Surgery | 16.7 percentage of participants |
| T+P Concomitant Non-Anthracycline Chemotherapy | Efficacy: Percentage of Participants Achieving Breast Conserving Surgery | 27.0 percentage of participants |
Secondary
Efficacy: Percentage of Participants With Complete Pathological Response (pCR)
pCR is defined as the absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. pCR is evaluated after 6 cycles of treatment and surgery or following withdrawal from the study whichever occurs sooner.
Time frame: At surgery, after 18 weeks (6 cycles) of treatment
Population: Intent to treat (ITT) population included all participants who were randomized to treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| T+P Concomitant Anthracycline-based Chemotherapy | Efficacy: Percentage of Participants With Complete Pathological Response (pCR) | 61.6 percentage of participants |
| T+P Sequential Anthracycline-based Chemotherapy | Efficacy: Percentage of Participants With Complete Pathological Response (pCR) | 57.3 percentage of participants |
| T+P Concomitant Non-Anthracycline Chemotherapy | Efficacy: Percentage of Participants With Complete Pathological Response (pCR) | 66.2 percentage of participants |
Secondary
Efficacy: Percentage of Participants Without a Disease-Free Survival (DFS) Event
The DFS was defined as the time from the first date of no disease (i.e., date of surgery) to the first documentation of progressive disease (PD) or death. PD was assessed using RECIST v1.0 and MRI and CBE. It was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions. Any evidence of contralateral disease in situ was not considered as PD. Participants who were withdrawn from the study without documented PD were censored at the date of the last assessment when the participant was known to be disease-free.
Time frame: From baseline to end of study up to 5 years
Population: ITT population included all participants who were randomized to treatment. Number of participants analyzed is total number of participants evaluable during each period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| T+P Concomitant Anthracycline-based Chemotherapy | Efficacy: Percentage of Participants Without a Disease-Free Survival (DFS) Event | 85.5 percentage of participants |
| T+P Sequential Anthracycline-based Chemotherapy | Efficacy: Percentage of Participants Without a Disease-Free Survival (DFS) Event | 88.1 percentage of participants |
| T+P Concomitant Non-Anthracycline Chemotherapy | Efficacy: Percentage of Participants Without a Disease-Free Survival (DFS) Event | 84.7 percentage of participants |
Secondary
Efficacy: Percentage of Participants Without an Overall Survival (OS) Event
Overall survival (OS) was defined as the time from randomization to the date of death from any cause. Participants who were alive or lost to follow-up were censored at the last known alive date. Participants with no post-baseline information were censored at the date of randomization plus one day.
Time frame: From baseline to end of study up to 5 years
Population: ITT population included all participants who were randomized to treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| T+P Concomitant Anthracycline-based Chemotherapy | Efficacy: Percentage of Participants Without an Overall Survival (OS) Event | 93.2 percentage of participants |
| T+P Sequential Anthracycline-based Chemotherapy | Efficacy: Percentage of Participants Without an Overall Survival (OS) Event | 90.7 percentage of participants |
| T+P Concomitant Non-Anthracycline Chemotherapy | Efficacy: Percentage of Participants Without an Overall Survival (OS) Event | 87.0 percentage of participants |
Secondary
Efficacy: Percentage of Participants Without a Progression-Free Survival (PFS) Event
Progression-free survival was defined as the time from the date of randomization to the first documentation of PD or death from any cause, whichever occurred first. PD was assessed using RECIST v1.0 and MRI and CBE. It was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions. Participants who were withdrawn from the study without documented PD were censored at the date of the last assessment when the participant was known to be free from PD. Participants without post-baseline assessments but known to be alive were censored at the time of randomization plus one day.
Time frame: From baseline to end of study up to 5 years
Population: ITT population included all participants who were randomized to treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| T+P Concomitant Anthracycline-based Chemotherapy | Efficacy: Percentage of Participants Without a Progression-Free Survival (PFS) Event | 86.3 percentage of participants |
| T+P Sequential Anthracycline-based Chemotherapy | Efficacy: Percentage of Participants Without a Progression-Free Survival (PFS) Event | 85.3 percentage of participants |
| T+P Concomitant Non-Anthracycline Chemotherapy | Efficacy: Percentage of Participants Without a Progression-Free Survival (PFS) Event | 81.8 percentage of participants |
Secondary
Efficacy: Time to Clinical Response
Time to clinical response is defined as the time from the date of first dose received to the first date of assessment of clinical response. Clinical response is defined as a response of CR or PR at any time pre-surgery. Per RECIST v1.0 for target lesions and assessed by mammogram or MRI and CBE, CR is disappearance of all target lesions; PR is \>=30% decrease in the sum of the longest diameter of target lesions.
Time frame: Up to 18 weeks
Population: ITT population included all participants who were randomized to treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| T+P Concomitant Anthracycline-based Chemotherapy | Efficacy: Time to Clinical Response | 3.6 weeks |
| T+P Sequential Anthracycline-based Chemotherapy | Efficacy: Time to Clinical Response | 6.3 weeks |
| T+P Concomitant Non-Anthracycline Chemotherapy | Efficacy: Time to Clinical Response | 4.9 weeks |
Secondary
Safety: Maximum Decrease in Left Ventricular Ejection Fraction (LVEF) Measures
Maximum decrease in LVEF measures is the change from baseline at worst treatment value. LVEF is measured as percentage.
Time frame: From baseline up to approximately 3.5 years
Population: Safety analysis population included all randomized participants who received treatment. Number of participants analyzed is total number of participants evaluable.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| T+P Concomitant Anthracycline-based Chemotherapy | Safety: Maximum Decrease in Left Ventricular Ejection Fraction (LVEF) Measures | -6.6 percentage (ejection fraction) | Standard Deviation 5.15 |
| T+P Sequential Anthracycline-based Chemotherapy | Safety: Maximum Decrease in Left Ventricular Ejection Fraction (LVEF) Measures | -8.4 percentage (ejection fraction) | Standard Deviation 5.66 |
| T+P Concomitant Non-Anthracycline Chemotherapy | Safety: Maximum Decrease in Left Ventricular Ejection Fraction (LVEF) Measures | -7.0 percentage (ejection fraction) | Standard Deviation 6.48 |
Secondary
Safety: Percentage of Participants With Asymptomatic Left Ventricular Ejection Fraction (LVEF) Events
Percentage of participants with LVEF events without signs or symptoms of cardiac events.
Time frame: From baseline to end of Neoadjuvant Period (up to 18 weeks), Adjuvant Period (up to 1.5 years), Follow-up Period (up to 3.5 years)
Population: Safety analysis population included all randomized participants who received treatment. Number of participants analyzed is total number of participants evaluable during each period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T+P Concomitant Anthracycline-based Chemotherapy | Safety: Percentage of Participants With Asymptomatic Left Ventricular Ejection Fraction (LVEF) Events | Adjuvant Period (n= 66, 64, 63) | 3.0 percentage of participants |
| T+P Concomitant Anthracycline-based Chemotherapy | Safety: Percentage of Participants With Asymptomatic Left Ventricular Ejection Fraction (LVEF) Events | Neoadjuvant Period (n=72, 75, 76) | 5.6 percentage of participants |
| T+P Concomitant Anthracycline-based Chemotherapy | Safety: Percentage of Participants With Asymptomatic Left Ventricular Ejection Fraction (LVEF) Events | Follow-up Period (n=21, 18, 23) | 0 percentage of participants |
| T+P Sequential Anthracycline-based Chemotherapy | Safety: Percentage of Participants With Asymptomatic Left Ventricular Ejection Fraction (LVEF) Events | Adjuvant Period (n= 66, 64, 63) | 0 percentage of participants |
| T+P Sequential Anthracycline-based Chemotherapy | Safety: Percentage of Participants With Asymptomatic Left Ventricular Ejection Fraction (LVEF) Events | Neoadjuvant Period (n=72, 75, 76) | 4.0 percentage of participants |
| T+P Sequential Anthracycline-based Chemotherapy | Safety: Percentage of Participants With Asymptomatic Left Ventricular Ejection Fraction (LVEF) Events | Follow-up Period (n=21, 18, 23) | 11.1 percentage of participants |
| T+P Concomitant Non-Anthracycline Chemotherapy | Safety: Percentage of Participants With Asymptomatic Left Ventricular Ejection Fraction (LVEF) Events | Neoadjuvant Period (n=72, 75, 76) | 2.6 percentage of participants |
| T+P Concomitant Non-Anthracycline Chemotherapy | Safety: Percentage of Participants With Asymptomatic Left Ventricular Ejection Fraction (LVEF) Events | Follow-up Period (n=21, 18, 23) | 4.3 percentage of participants |
| T+P Concomitant Non-Anthracycline Chemotherapy | Safety: Percentage of Participants With Asymptomatic Left Ventricular Ejection Fraction (LVEF) Events | Adjuvant Period (n= 66, 64, 63) | 4.8 percentage of participants |
Secondary
Safety: Percentage of Participants With Cardiac Symptoms Associated With Symptomatic Left Ventricular Systolic Dysfunction (LVSD)
Percentage of participants with signs or symptoms of cardiac events.
Time frame: From Baseline to end of Neoadjuvant Period (up to 18 weeks), Adjuvant Period (up to 1.5 years), Follow-up Period (up to 3.5 years)
Population: Safety analysis population included all randomized participants who received treatment. Number of participants analyzed is total number of participants evaluable during each period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| T+P Concomitant Anthracycline-based Chemotherapy | Safety: Percentage of Participants With Cardiac Symptoms Associated With Symptomatic Left Ventricular Systolic Dysfunction (LVSD) | Adjuvant Period (n= 68, 65, 67) | 0 percentage of participants |
| T+P Concomitant Anthracycline-based Chemotherapy | Safety: Percentage of Participants With Cardiac Symptoms Associated With Symptomatic Left Ventricular Systolic Dysfunction (LVSD) | Neoadjuvant Period (n=72, 75, 76) | 1.4 percentage of participants |
| T+P Concomitant Anthracycline-based Chemotherapy | Safety: Percentage of Participants With Cardiac Symptoms Associated With Symptomatic Left Ventricular Systolic Dysfunction (LVSD) | Follow-up Period (n=70, 75, 74) | 0 percentage of participants |
| T+P Sequential Anthracycline-based Chemotherapy | Safety: Percentage of Participants With Cardiac Symptoms Associated With Symptomatic Left Ventricular Systolic Dysfunction (LVSD) | Adjuvant Period (n= 68, 65, 67) | 0 percentage of participants |
| T+P Sequential Anthracycline-based Chemotherapy | Safety: Percentage of Participants With Cardiac Symptoms Associated With Symptomatic Left Ventricular Systolic Dysfunction (LVSD) | Neoadjuvant Period (n=72, 75, 76) | 2.7 percentage of participants |
| T+P Sequential Anthracycline-based Chemotherapy | Safety: Percentage of Participants With Cardiac Symptoms Associated With Symptomatic Left Ventricular Systolic Dysfunction (LVSD) | Follow-up Period (n=70, 75, 74) | 1.3 percentage of participants |
| T+P Concomitant Non-Anthracycline Chemotherapy | Safety: Percentage of Participants With Cardiac Symptoms Associated With Symptomatic Left Ventricular Systolic Dysfunction (LVSD) | Neoadjuvant Period (n=72, 75, 76) | 0 percentage of participants |
| T+P Concomitant Non-Anthracycline Chemotherapy | Safety: Percentage of Participants With Cardiac Symptoms Associated With Symptomatic Left Ventricular Systolic Dysfunction (LVSD) | Follow-up Period (n=70, 75, 74) | 0 percentage of participants |
| T+P Concomitant Non-Anthracycline Chemotherapy | Safety: Percentage of Participants With Cardiac Symptoms Associated With Symptomatic Left Ventricular Systolic Dysfunction (LVSD) | Adjuvant Period (n= 68, 65, 67) | 1.5 percentage of participants |