NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
A Study to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel Versus Placebo + Trastuzumab + Docetaxel in Previously Untreated Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer
A Study to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel Versus Placebo + Trastuzumab + Docetaxel in Previously Untreated Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer
CompletedPhase 3
Sponsor: Hoffmann-La Roche
Conditions: Breast Cancer
Interventions: Docetaxel, Pertuzumab, Placebo, Trastuzumab
Countries: China
This Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial in China will evaluate the efficacy and safety of pertuzumab + trastuzumab + docetaxel compared with placebo + trastuzumab + docetaxel in participants with previously untreated HER2-positive metastatic breast cancer.
Eligibility overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Eligibility criteria
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease that is suitable for chemotherapy * HER2-positive metastatic breast cancer (MBC) * Left ventricular ejection fraction (LVEF) greater than or equal to (\>=) 55 percent (%) at baseline (within 42 days of randomization) * Eastern Cooperative Oncology Group Performance Status of 0 or 1 * Women of childbearing potential and men should agree to use an effective form of contraception and to continue its use for the duration of study treatment and for at least 7 months after the last dose of study treatment (trastuzumab and/or pertuzumab) Exclusion Criteria: * 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 less than (\<) 12 months * History of persistent Grade \>= 2 hematologic toxicity resulting from previous adjuvant therapy * Grade \>= 3 peripheral neuropathy at randomization * History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or non-melanoma skin carcinoma that has been previously treated with curative intent * Current clinical or radiographic evidence of central nervous system (CNS) 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) classification, or serious cardiac arrhythmia requiring treatment * History of myocardial infarction within 6 months of randomization * History of LVEF decrease to \< 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 C virus (HCV), or active hepatitis B virus (HBV) * 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 protocol-specified study treatments * Concurrent participation in an interventional or noninterventional study
Locations (15)
- Beijing, China
- Beijing, China
- Beijing, China
- Changchun, China
- Changzhou, China
- Chengdu, China
- Fuzhou, China
- Guangzhou, China
- Harbin, China
- Nanjing, China
- Nanjing, China
- Shanghai, China
- Shenyang, China
- Shenyang, China
- Zhejiang, China