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
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Docetaxel; Pertuzumab; Placebo; Trastuzumab
Intervention description: Docetaxel (75-mg/m^2) was administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.; Pertuzumab (840-mg loading dose for Cycle 1, followed by 420 mg for subsequent cycles) was administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.; Placebo matched to pertuzumab was administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.; Trastuzumab (8-mg/kg loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles) was administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.
Intervention MeSH terms: Docetaxel; Trastuzumab; Pertuzumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 243.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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