Clinical trial NCT00567190 (phase 3, status: completed)
Conditions: metastatic breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: pertuzumab, placebo, trastuzumab, docetaxel
SMILES: 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, [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, and candidate for chemotherapy. Participants with
             measurable and non-measurable disease are eligible (locally recurrent disease must not
             be amenable to resection with curative intent; participants with de novo Stage IV
             disease are eligible)

          -  Human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer
             (MBC)

          -  Left ventricular ejection fraction (LVEF) ≥50 percent (%) at baseline (within 42 days
             of randomization)

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

          -  For women of childbearing potential and men with partners of childbearing potential,
             agreement to use a highly 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

        Exclusion Criteria:

          -  History of anti-cancer therapy for MBC (with the exception of one prior hormonal
             regimen for MBC, which must be stopped prior to randomization)

          -  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

          -  Current peripheral neuropathy of National Cancer Institute-Common Terminology Criteria
             for Adverse Events (NCI-CTCAE) Version 3.0, Grade ≥3 at randomization

          -  History of other malignancy within the last 5 years, except for carcinoma in situ of
             the cervix, basal cell carcinoma or squamous cell carcinoma of the skin that has been
             previously treated with curative intent

          -  Current clinical or radiographic evidence of central nervous system (CNS) metastases

          -  Computed tomography (CT) or magnetic resonance imaging (MRI) scan of the brain is
             mandatory in cases of clinical suspicion of brain 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)
             criteria, or serious cardiac arrhythmia requiring treatment (exception: atrial
             fibrillation or paroxysmal supraventricular tachycardia)

          -  History of myocardial infarction within 6 months of randomization

          -  History of LVEF decline to below 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, as defined in the protocol, 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 B virus
             (HBV), or hepatitis C virus (HCV)

          -  Receipt of IV antibiotics for infection within 14 days of randomization

          -  Current chronic daily treatment with corticosteroids (excluding inhaled steroids)

          -  Known hypersensitivity to any of the study drugs

          -  Assessed by the investigator to be unable or unwilling to comply with the requirements
             of the protocol