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

Conditions: Breast Cancer

Summary: 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 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