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

• Status: Completed
• Trial end date: 2021-01-22
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Docetaxel; Pertuzumab; Trastuzumab

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