|Phase III||Treatment||Closed||18 and over||Pharmaceutical / Industry||TOC4129g|
This study is a Phase III, randomized, double-blind, placebo-controlled, multicenter international clinical trial. Patients who have human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) and have not received chemotherapy or biological therapy (including approved or investigational tyrosine kinase/HER inhibitors or vaccines) for their metastatic disease are eligible for study. Patients could have received one prior hormonal treatment for MBC. Patients may have received systemic breast cancer treatment in the neo-adjuvant or adjuvant setting, provided that the patient has experienced a disease-free interval (DFI) of ≥ 12 months from completion of adjuvant systemic treatment (excluding hormonal therapy) to metastatic diagnosis. Patients may have received trastuzumab and/or a taxane during the neo-adjuvant or adjuvant treatment.
- Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease, and candidate for chemotherapy. Patients with measurable and non-measurable disease are eligible (locally recurrent disease must not be amenable to resection with curative intent; patients with de novo Stage IV disease are eligible).
- Human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC).
- Age ≥ 18 years.
- Left ventricular ejection fraction (LVEF) ≥ 50% at baseline (within 42 days of randomization).
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) = 0 or 1.
- For women of childbearing potential, agreement to use an effective form of contraception and to continue its use for the duration of study treatment and for 6 months after the last dose of study treatment.
- Signed, written informed consent obtained prior to any study procedure.
- History of anti-cancer therapy for MBC (with the exception of one prior hormonal regimen for MBC).
- History of approved or investigative tyrosine kinase/HER inhibitors for breast cancer in any treatment setting, except trastuzumab used in the neoadjuvant or adjuvant setting.
- History of systemic breast cancer treatment in the neo-adjuvant or adjuvant setting with a disease-free interval from completion of the systemic treatment (excluding hormonal therapy) to metastatic diagnosis of < 12 months.
- History of persistent Grade ≥ 2 hematologic toxicity resulting from previous adjuvant therapy.
- Current peripheral neuropathy of National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 3.0, Grade ≥ 3 at randomization.
- History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma.
- Current clinical or radiographic evidence of central nervous system (CNS) metastases.
- Computed tomography (CT) or magnetic resonance imaging (MRI) scan of the brain is mandatory in cases of clinical suspicion of brain metastases.
- History of exposure to cumulative doses of anthracyclines.
- Current uncontrolled hypertension or unstable angina.
- History of congestive heart failure (CHF) of any New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment.
- History of myocardial infarction within 6 months of randomization.
- History of LVEF decline to below 50% during or after prior trastuzumab neo-adjuvant or adjuvant therapy.
- Current dyspnea at rest due to complications of advanced malignancy, or other diseases that require continuous oxygen therapy.
- Inadequate organ function within 28 days prior to randomization.
- Current severe, uncontrolled systemic disease.
- Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start or anticipation of the need for major surgery during the course of study treatment.
- Pregnant or lactating women.
- History of receiving any investigational treatment within 28 days of randomization.
- Current known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV).
- Receipt of intravenous (IV) antibiotics for infection within 14 days of randomization.
- Current chronic daily treatment with corticosteroids (excluding inhaled steroids).
- Known hypersensitivity to any of the study drugs.
- Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
Trial Lead Organizations/Sponsors
Genentech IncorporatedF. Hoffmann - La Roche, Limited
|Ru Walker, M.D.||Study Director|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00567190
ClinicalTrials.gov processed this data on October 17, 2013
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