None listed
Conditions
Interventions
Group 1 Type of group
Patients receive trastuzumab emtansine 3.6 mg/kg intravenously (IV) administered over 30-90 minutes every 3 weeks on Day 1 of each 21-day cycle.
Group name:Group 2 Type of group
Patients receive a loading dose of trastuzumab 8 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of Cycle 1 followed by trastuzumab 6 mg/kg IV + docetaxel 75 or 100 mg/m^2 IV on Day 1 of all subsequent 21-day cycles.
Sponsors
F. HOFFMANN-LA ROCHE LTD., GENENTECH, INC.,
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Histologically or cytologically confirmed adenocarcinoma of the breast with locally advanced or metastatic disease, and a candidate for chemotherapy. • Human epidermal growth factor receptor 2 (HER2)-positive. • No prior chemotherapy for their metastatic breast cancer (MBC). • Measurable disease. • Age ≥ 18 years. • For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective, non-hormonal form of contraception or 2 effective forms of non-hormonal contraception by the patient and/or partner. Contraception use must continue for the duration of study treatment and for at least 6 months after the last dose of study treatment. Male patients whose partners are pregnant should use condoms for the duration of the study.
Exclusion criteria
Exclusion criteria: • History of any chemotherapy for MBC. • An interval of 500 mg/m^2; epirubicin > 900 mg/m^2; mitoxantrone > 120mg/m^2 and idarubicin > 90 mg/m^2. • Current unstable angina. • History of symptomatic congestive heart failure, or ventricular arrhythmia requiring treatment. • History of myocardial infarction within 6 months prior to randomization. • Left ventricular ejection fraction (LVEF) below 50% within approximately 28 days prior to randomization. • History of decreased LVEF or symptomatic congestive heart failure (CHF) with previous adjuvant trastuzumab treatment. • Cardiac troponin I ≥ 0.2 ng/mL within 28 days of randomization. • Severe dyspnea at rest because of complications of advanced malignancy or requiring current continuous oxygen therapy. • Current severe, uncontrolled systemic disease (eg, clinically significant cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures). • Major surgical procedure or significant traumatic injury within approximately 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment. • Current pregnancy or lactation. • History of receiving any investigational treatment within approximately 28 days prior to randomization. • Current known infection with human immunodeficiency virus (HIV), active hepatitis B and/or hepatitis C virus. • History of intolerance (including Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab, murine proteins, or docetaxel. • Known hypersensitivity to any of the study drugs, including the excipients, or any drugs formulated in polysorbate 80. • Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:PFS was defined as the time from randomization (R) to first documented investigator-assessed radiographic or clinical disease progression (PD) or death due to any cause, whichever occurred first. For target lesions (TL), PD was defined as at least a 20% increase in the sum of the longest diameter (SLD) of TLs, taking as reference the SLD recorded since treatment started or the appearance of 1 or more new lesions. For non-TLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-TLs. Data for patients without PD or death were censored at the last date of tumor assessment prior to crossover (or, if no tumor assessment was performed after Baseline, at the R date +1 day). Data for patients who were lost to follow-up were censored at the last date of tumor assessment prior to crossover at which the patient was known to be progression free. Data for patients with no post-baseline tumor assessment were censored at the R date +1 day. Measure:Progression-free Survival (PFS) by the Investigator Using Modified Response Evaluation Criteria In Solid Tumors (RECIST) Timepoints:Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Overall survival was defined as the time from randomization to the date of death from any cause. Patients who were alive at the time of analysis were censored at the date on which they were last known to be alive. Patients with no post-baseline were censored at the date of randomization plus 1 day. Measure:Overall Survival Timepoints:Baseline through the data cut-off date of 31 Aug 2011 (up to 2 years, 11 months) ; Outcome name:A patient had an objective response if they had a complete response or a partial response on 2 consecutive occasions ≥ 4 weeks apart. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions; a partial response was defined as the persistence of 1 or more non-target lesions. Measure:Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST) Timepoints:Baseline through the data cut-off date of 15 Nov 2010 (up to 2 years, 2 months) ; Outcome name:Duration of objective response was defined as the time from initial response to investigator-assessed radiographic or clinical disease progression or death on study from any cause. For target lesions, disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since treatment started or the appearance of 1 or more new lesions. For non-target lesions, disease progression was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing non-target lesions. Target lesions should be selected on the basis of their size (those with the longest diameter) an | — |
Countries
Austria, Belgium, Brazil, Chile, Hungary, Israel, Italy, Mexico, Peru, Spain, Switzerland, United Kindgdom, United States
Contacts
Public ContactMarcela Toledo
ICON CLINICAL RESEARCH PERU S.A.
Outcome results
None listed