Clinical trial NCT02896855 (phase 3, status: active, not recruiting)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: docetaxel, pertuzumab, placebo, trastuzumab
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
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