Breast Cancer
Conditions
Brief summary
To evaluate the efficacy and safety of treatment with MYOCET® (doxorubicin hydrochloride) in combination with cyclophosphamide and trastuzumab, 4 cycles, followed by docetaxel plus trastuzumab, 4 cycles, in women with stage II or III breast cancer whose tumour overexpresses the human epidermal growth factor receptor 2 (HER2) gene.
Interventions
DRUGLiposomal doxorubicin hydrochloride
Liposomal doxorubicin hydrochloride will be administered per dose and schedule specified in the arm description.
DRUGCyclophosphamide
Cyclophosphamide will be administered per dose and schedule specified in the arm description.
DRUGTrastuzumab
Trastuzumab will be administered per dose and schedule specified in the arm description.
DRUGFree doxorubicin hydrochloride
Free doxorubicin hydrochloride will be administered per dose and schedule specified in the arm description.
DRUGDocetaxel
Docetaxel will be administered per dose and schedule specified in the arm description.
Sponsors
Cephalon, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: * Treatment-naive participants with stage II or III invasive breast cancer (proven histologically/cytologically) and with tests showing an overexpressing of HER2. * Participants have at least 1 bidimensionally measurable lesion according to the World Health Organization (WHO) criteria. * The participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * The participant has an LVEF of at least 55% as assessed by multigated acquisition (MUGA) scan (preferred) or echocardiography. * The participant has hematology and serum chemistry laboratory test results within specific protocol-defined ranges. * Women of childbearing potential must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the treatment period and for 6 months after the last administration of study drug. Main
Exclusion criteria
The participant: * Has received previous cancer therapy for breast cancer. * Has any history of CHF, angina pectoris, or myocardial infarction. * Has uncontrolled hypertension. * Has infection, peptic ulcer, or unstable diabetes mellitus. * Has been treated with live virus vaccines within 8 weeks before the first administration of study drug. * Has impaired hepatic or renal function. * Is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.) * Has used an investigational drug within one month before the screening visit. * Has a known hypersensitivity to any of the study drugs or to their active ingredients. * Has an inflammatory breast cancer. * Has had any other malignancies within five years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer). Note: Other inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Exhibiting a Pathological Complete Response (pCR) in Breast | At the end of Cycle 8 (each cycle length = 21 days) | The pCR of breast was based upon histologic examination, as confirmed by a central panel of experts, of resected tissue . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Class III or IV New York Health Association (NYHA) Congestive Heart Failure (CHF) | Baseline up to the end of Cycle 8 (each cycle length = 21 days) | Occurrence of Class III or IV (NYHA) CHF has been reported. Class III: Participants with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain. Class IV: Participants with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased. |
| Change From Baseline in Left Ventricular Ejection Fraction (LVEF) | Baseline, up to 5 years | The LVEF is a fraction of blood (in percent) pumped out of the left ventricle of the heart (the main pumping chamber). LVEF was measured using multigated acquisition (MUGA) or echocardiography. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Baseline up to the end of Cycle 8 (cycle length = 21 days) | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. The TEAE was an AE that began or worsened after treatment with study drug. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'. |
| Percentage of Participants Who Achieved an Objective Response (Complete Response [CR] or Partial Response [PR]), as Defined by World Health Organization (WHO) Guidelines | At the end of Cycle 8 (each cycle length = 21 days) | CR: Disappearance of the lesions and no new lesions. In case of bone metastasis a CR is represented by the normalization of radiography or the complete sclerotic healing of lytic area. PR: In the case of bidimensionally measurable lesions/tumors, a decrease by at least 50% of the sum of the products of the largest perpendicular diameters of each individual lesion/tumor. In the case of unidimensionally measurable lesions a decrease by at least 50% in the largest linear tumour measurement. In the case of non-measurable but evaluable lesions an appreciable change of lesions referable to disease improvement. For bone lesions partial decrease in size or recalcification of lytic areas. No lesion should have progressed and no new lesion should appear. |
| Percentage of Participants Achieving a Pathological Complete Response (pCR) in Breast and Node | At the end of Cycle 8 (each cycle length = 21 days) | The pCR of breast and node was based upon histologic examination, as confirmed by a central panel of experts, of breast tissue resected. |
| Number of Participants Undergoing Breast Conservative Surgery | At the end of Cycle 8 (each cycle length = 21 days) | — |
| Severity of Adverse Events as Characterized by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Up to Week 24 | AEs were recorded and graded per the NCI CTCAE scale. The NCI CTCAE is a toxicity scale used to grade the severity of adverse events experienced with cancer treatment. Grade 1= Mild; Grade 2= Moderate; Grade 3= Severe; Grade 4= Life-threatening or disabling; Grade 5= Death related to AE. For summaries for the toxicity grade, participants were counted once at the greatest NCI CTCAE grade. |
| Percentage of Participants With Progression or Death | Up to 5 Years after randomization | Progression was defined as a 25% or more increase in the size of the lesion or appearance of new lesion. If the participant did not develop an event (disease progression or death), the participant was censored at the last known tumor assessment date (or last follow-up visit without progression documented). |
Countries
Austria, Belgium, France, Germany, Italy, Spain
Participant flow
Pre-assignment details
Participants were randomly assigned in 1:1 ratio to investigational group (Doxorubicin \[MYOCET\] + Cyclophosphamide + Trastuzumab \[MCH\] and Docetaxel + Trastuzumab \[TH\]) and comparison group (Doxorubicin \[Anthracycline\] + Cyclophosphamide \[AC\] and Docetaxel + Trastuzumab \[TH\]).
Participants by arm
| Arm | Count |
|---|---|
| Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH) Participants received MCH (liposomal doxorubicin hydrochloride \[60 mg/m\^2\], cyclophosphamide (600 mg/m\^2), and trastuzumab (8 or 6 mg/kg), administered as IV infusion on Day 1 of each of 4 consecutive 21-day cycles. For the first cycle, the loading dose of trastuzumab was 8 mg/kg; 6 mg/kg was used for the remaining cycles. After 4 cycles of MCH, the treatment changed to 4 consecutive 21-day cycles of TH (docetaxel \[100 mg/m\^2\] and trastuzumab \[6 mg/kg\]). | 63 |
| Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) Participants received AC (free doxorubicin hydrochloride \[60 mg/m\^2\] and cyclophosphamide \[600 mg/m\^2\]), administered as IV infusion on Day 1 of each of 4 consecutive 21-day cycles. After 4 cycles of AC, the treatment changed to 4 consecutive 21-day cycles of TH (docetaxel \[100 mg/m\^2\] and trastuzumab \[8 or 6 mg/kg\]). For the first cycle, the loading dose of trastuzumab was 8 mg/kg; 6 mg/kg was used for the remaining cycles. | 63 |
| Total | 126 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 3 |
| Overall Study | Disease Progression | 2 | 1 |
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Non-Compliance To Study Procedures | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Randomized but not treated | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) | Total | Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH) |
|---|---|---|---|
| Age, Continuous | 51.1 years STANDARD_DEVIATION 11.3 | 49.9 years STANDARD_DEVIATION 11.4 | 48.8 years STANDARD_DEVIATION 11.6 |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 59 Participants | 120 Participants | 61 Participants |
| Sex: Female, Male Female | 63 Participants | 126 Participants | 63 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 | 0 / 62 | 4 / 63 |
| other Total, other adverse events | 62 / 62 | 63 / 63 |
| serious Total, serious adverse events | 18 / 62 | 21 / 63 |
Outcome results
Primary
Percentage of Participants Exhibiting a Pathological Complete Response (pCR) in Breast
The pCR of breast was based upon histologic examination, as confirmed by a central panel of experts, of resected tissue .
Time frame: At the end of Cycle 8 (each cycle length = 21 days)
Population: The set of enrolled participants included all participants who were randomized to a treatment group, regardless of whether or not a participant received any study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH) | Percentage of Participants Exhibiting a Pathological Complete Response (pCR) in Breast | 41.3 percentage of participants |
| Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) | Percentage of Participants Exhibiting a Pathological Complete Response (pCR) in Breast | 54.0 percentage of participants |
p-value: 0.1542-sided, binomial proportions
Secondary
Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
The LVEF is a fraction of blood (in percent) pumped out of the left ventricle of the heart (the main pumping chamber). LVEF was measured using multigated acquisition (MUGA) or echocardiography.
Time frame: Baseline, up to 5 years
Population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug. Here, 'Number analyzed' = participants evaluable for specified category.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH) | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) | Change at Cycle 4 | -1.5 percentage of blood pumped out | Standard Deviation 6.5 |
| Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH) | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) | Change at Pre-surgery Visit | -0.8 percentage of blood pumped out | Standard Deviation 7.1 |
| Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH) | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) | Change at Post-surgery Visit | -1.6 percentage of blood pumped out | Standard Deviation 7.3 |
| Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH) | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) | Change at Month 12 | -0.9 percentage of blood pumped out | Standard Deviation 7 |
| Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH) | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) | Change at Month 24 | 0.6 percentage of blood pumped out | Standard Deviation 8 |
| Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH) | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) | Change at Month 36 | 2.1 percentage of blood pumped out | Standard Deviation 5.6 |
| Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH) | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) | Change at Month 48 | -1.3 percentage of blood pumped out | Standard Deviation 8.3 |
| Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH) | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) | Change at Month 60 | -1.0 percentage of blood pumped out | Standard Deviation 7.7 |
| Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) | Change at Month 60 | -1.4 percentage of blood pumped out | Standard Deviation 11 |
| Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) | Change at Cycle 4 | -1.0 percentage of blood pumped out | Standard Deviation 5.3 |
| Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) | Change at Month 24 | -4.7 percentage of blood pumped out | Standard Deviation 7.9 |
| Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) | Change at Pre-surgery Visit | -3.4 percentage of blood pumped out | Standard Deviation 6.4 |
| Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) | Change at Month 48 | -2.5 percentage of blood pumped out | Standard Deviation 9 |
| Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) | Change at Post-surgery Visit | -3.6 percentage of blood pumped out | Standard Deviation 5.7 |
| Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) | Change at Month 36 | -3.8 percentage of blood pumped out | Standard Deviation 7.4 |
| Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) | Change From Baseline in Left Ventricular Ejection Fraction (LVEF) | Change at Month 12 | -4.4 percentage of blood pumped out | Standard Deviation 8 |
Secondary
Number of Participants Undergoing Breast Conservative Surgery
Time frame: At the end of Cycle 8 (each cycle length = 21 days)
Population: The set of enrolled participants included all participants who were randomized to a treatment group, regardless of whether or not a participant received any study drug.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH) | Number of Participants Undergoing Breast Conservative Surgery | Missing data | 7 Participants |
| Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH) | Number of Participants Undergoing Breast Conservative Surgery | Had breast conservative surgery | 33 Participants |
| Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH) | Number of Participants Undergoing Breast Conservative Surgery | Did not have breast conservative surgery | 23 Participants |
| Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) | Number of Participants Undergoing Breast Conservative Surgery | Missing data | 5 Participants |
| Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) | Number of Participants Undergoing Breast Conservative Surgery | Had breast conservative surgery | 31 Participants |
| Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) | Number of Participants Undergoing Breast Conservative Surgery | Did not have breast conservative surgery | 27 Participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. The TEAE was an AE that began or worsened after treatment with study drug. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Time frame: Baseline up to the end of Cycle 8 (cycle length = 21 days)
Population: The safety analysis set included all enrolled participants who received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 62 Participants |
| Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 63 Participants |
Secondary
Percentage of Participants Achieving a Pathological Complete Response (pCR) in Breast and Node
The pCR of breast and node was based upon histologic examination, as confirmed by a central panel of experts, of breast tissue resected.
Time frame: At the end of Cycle 8 (each cycle length = 21 days)
Population: The set of enrolled participants included all participants who were randomized to a treatment group, regardless of whether or not a participant received any study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH) | Percentage of Participants Achieving a Pathological Complete Response (pCR) in Breast and Node | 38.1 percentage of participants |
| Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) | Percentage of Participants Achieving a Pathological Complete Response (pCR) in Breast and Node | 47.6 percentage of participants |
Secondary
Percentage of Participants Who Achieved an Objective Response (Complete Response [CR] or Partial Response [PR]), as Defined by World Health Organization (WHO) Guidelines
CR: Disappearance of the lesions and no new lesions. In case of bone metastasis a CR is represented by the normalization of radiography or the complete sclerotic healing of lytic area. PR: In the case of bidimensionally measurable lesions/tumors, a decrease by at least 50% of the sum of the products of the largest perpendicular diameters of each individual lesion/tumor. In the case of unidimensionally measurable lesions a decrease by at least 50% in the largest linear tumour measurement. In the case of non-measurable but evaluable lesions an appreciable change of lesions referable to disease improvement. For bone lesions partial decrease in size or recalcification of lytic areas. No lesion should have progressed and no new lesion should appear.
Time frame: At the end of Cycle 8 (each cycle length = 21 days)
Population: The set of enrolled participants included all participants who were randomized to a treatment group, regardless of whether or not a participant received any study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH) | Percentage of Participants Who Achieved an Objective Response (Complete Response [CR] or Partial Response [PR]), as Defined by World Health Organization (WHO) Guidelines | 77.8 percentage of participants |
| Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) | Percentage of Participants Who Achieved an Objective Response (Complete Response [CR] or Partial Response [PR]), as Defined by World Health Organization (WHO) Guidelines | 84.1 percentage of participants |
Secondary
Percentage of Participants With Class III or IV New York Health Association (NYHA) Congestive Heart Failure (CHF)
Occurrence of Class III or IV (NYHA) CHF has been reported. Class III: Participants with cardiac disease resulting in marked limitation of physical activity. They are comfortable at rest. Less than ordinary activity causes fatigue, palpitation, dyspnea, or anginal pain. Class IV: Participants with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of heart failure or the anginal syndrome may be present even at rest. If any physical activity is undertaken, discomfort is increased.
Time frame: Baseline up to the end of Cycle 8 (each cycle length = 21 days)
Population: The set of enrolled participants included all participants who were randomized to a treatment group, regardless of whether or not a participant received any study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH) | Percentage of Participants With Class III or IV New York Health Association (NYHA) Congestive Heart Failure (CHF) | 0 percentage of participants |
| Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) | Percentage of Participants With Class III or IV New York Health Association (NYHA) Congestive Heart Failure (CHF) | 0 percentage of participants |
Secondary
Percentage of Participants With Progression or Death
Progression was defined as a 25% or more increase in the size of the lesion or appearance of new lesion. If the participant did not develop an event (disease progression or death), the participant was censored at the last known tumor assessment date (or last follow-up visit without progression documented).
Time frame: Up to 5 Years after randomization
Population: The set of enrolled participants included all participants who were randomized to a treatment group, regardless of whether or not a participant received any study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH) | Percentage of Participants With Progression or Death | Participants with progression or death | 11.1 percentage of participants |
| Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH) | Percentage of Participants With Progression or Death | Participants censored | 88.9 percentage of participants |
| Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) | Percentage of Participants With Progression or Death | Participants with progression or death | 12.7 percentage of participants |
| Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) | Percentage of Participants With Progression or Death | Participants censored | 87.3 percentage of participants |
Secondary
Severity of Adverse Events as Characterized by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
AEs were recorded and graded per the NCI CTCAE scale. The NCI CTCAE is a toxicity scale used to grade the severity of adverse events experienced with cancer treatment. Grade 1= Mild; Grade 2= Moderate; Grade 3= Severe; Grade 4= Life-threatening or disabling; Grade 5= Death related to AE. For summaries for the toxicity grade, participants were counted once at the greatest NCI CTCAE grade.
Time frame: Up to Week 24
Population: Safety analysis set
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH) | Severity of Adverse Events as Characterized by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 2 | 9 Participants |
| Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH) | Severity of Adverse Events as Characterized by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 4 | 32 Participants |
| Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH) | Severity of Adverse Events as Characterized by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 3 | 19 Participants |
| Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH) | Severity of Adverse Events as Characterized by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 5 | 0 Participants |
| Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH) | Severity of Adverse Events as Characterized by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 1 | 2 Participants |
| Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) | Severity of Adverse Events as Characterized by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 5 | 0 Participants |
| Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) | Severity of Adverse Events as Characterized by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 1 | 1 Participants |
| Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) | Severity of Adverse Events as Characterized by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 2 | 12 Participants |
| Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) | Severity of Adverse Events as Characterized by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 3 | 18 Participants |
| Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH) | Severity of Adverse Events as Characterized by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) | Grade 4 | 32 Participants |