Clareo Health | 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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
