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A Phase III, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab+Herceptin+Docetaxel Versus Placebo+Herceptin+Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer (NCT02896855)

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 MBC.
  • Drug: Docetaxel
    Docetaxel (75-mg/m^2) administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.
    • Drug: Pertuzumab
      Pertuzumab (840-mg loading dose for Cycle 1, followed by 420 mg for subsequent cycles) administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.
      • Perjeta
    • Drug: Placebo
      Placebo matched to pertuzumab administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.
      • Drug: Trastuzumab
        Trastuzumab (8-mg/kg loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles) administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.
        • Herceptin
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      Inclusion Criteria:
      • Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease that is suitable for chemotherapy
      • HER2-positive 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

      16 locations

      China (16)
      • CHINESE ACADEMY OF MEDICAL SCIENCE; CANCER INST. & HOSPITAL; Medical ward
        Not specified
        Beijing, China, 100021
      • Beijing Cancer Hospital
        Not specified
        Beijing, China, 100142
      • Chinese PLA General Hospital
        Not specified
        Beijing, China, 100853
      • the First Hospital of Jilin University
        Not specified
        Changchun, China, 130021
      • Changzhou First People's Hospital
        Not specified
        Changzhou, China, 213003
      • West China Hospital, Sichuan University
        Not specified
        Chengdu, China, 610041
      • Fuzhou General Hospital, PLA Nanjing Military Area Command
        Not specified
        Fuzhou, China, 110016
      • Guangdong General Hospital
        Not specified
        Guangzhou City, China, 510080
      • Zhejiang Cancer Hospital
        Not specified
        Hangzhou, China, 310022
      • Harbin Medical University Cancer Hospital
        Not specified
        Harbin, China, 150081
      • Shandong Cancer Hospital
        Not specified
        Jinan, China, 250117
      • Jiangsu Cancer Hospital
        Not specified
        Nanjing, China, 210009
      • Jiangsu province hospital; surgery on galactophore
        Not specified
        Nanjing, China, 210029
      • Fudan University Shanghai Cancer Center
        Not specified
        Shanghai, China, 200032
      • The First Hospital of China Medical University
        Not specified
        Shenyang, China, 110001
      • Liaoning cancer Hospital & Institute
        Not specified
        Shenyang, China, 110042
      Status:
      active not recruiting
      Type:
      Interventional
      Phase:
      Start:
      12 September, 2016
      Updated:
      12 October, 2017
      Participants:
      243
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