Clinical trial NCT00679341 (phase 2, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: trastuzumab emtansine [kadcyla], trastuzumab, docetaxel
SMILES: [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, [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
             advanced or metastatic disease, and a candidate for chemotherapy.

          -  Human epidermal growth factor receptor 2 (HER2)-positive.

          -  No prior chemotherapy for their metastatic breast cancer (MBC).

          -  Measurable disease.

          -  Age ≥ 18 years.

          -  For women of childbearing potential and men with partners of childbearing potential,
             agreement to use a highly effective, non-hormonal form of contraception or 2 effective
             forms of non-hormonal contraception by the patient and/or partner. Contraception use
             must continue for the duration of study treatment and for at least 6 months after the
             last dose of study treatment. Male patients whose partners are pregnant should use
             condoms for the duration of the study.

        Exclusion Criteria:

          -  History of any chemotherapy for MBC.

          -  An interval of < 6 months from the completion of cytotoxic chemotherapy in the
             neo-adjuvant or adjuvant setting until the time of metastatic diagnosis.

          -  Trastuzumab ≤ 21 days prior to randomization.

          -  Hormone therapy < 7 days prior to randomization.

          -  Current peripheral neuropathy of Grade ≥ 3.

          -  History of other malignancy within the last 5 years, except for appropriately treated
             carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer,
             or other cancers with a similar outcome as those previously mentioned.

          -  Previous radiotherapy for the treatment of unresectable, locally advanced or
             metastatic breast cancer is not allowed if more than 25% of marrow-bearing bone has
             been irradiated or the last fraction of radiotherapy has been administered within
             approximately 3 weeks prior to randomization.

          -  Brain metastases that are untreated, symptomatic, or require therapy to control
             symptoms or any radiation, surgery, or other therapy to control symptoms from brain
             metastases within 2 months prior to randomization.

          -  History of exposure to the following cumulative doses of anthracyclines: Doxorubicin
             or liposomal doxorubicin > 500 mg/m^2; epirubicin > 900 mg/m^2; mitoxantrone >
             120mg/m^2 and idarubicin > 90 mg/m^2.

          -  Current unstable angina.

          -  History of symptomatic congestive heart failure, or ventricular arrhythmia requiring
             treatment.

          -  History of myocardial infarction within 6 months prior to randomization.

          -  Left ventricular ejection fraction (LVEF) below 50% within approximately 28 days prior
             to randomization.

          -  History of decreased LVEF or symptomatic congestive heart failure (CHF) with previous
             adjuvant trastuzumab treatment.

          -  Cardiac troponin I ≥ 0.2 ng/mL within 28 days of randomization.

          -  Severe dyspnea at rest because of complications of advanced malignancy or requiring
             current continuous oxygen therapy.

          -  Current severe, uncontrolled systemic disease (eg, clinically significant
             cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; or
             bone fractures).

          -  Major surgical procedure or significant traumatic injury within approximately 28 days
             prior to randomization or anticipation of the need for major surgery during the course
             of study treatment.

          -  Current pregnancy or lactation.

          -  History of receiving any investigational treatment within approximately 28 days prior
             to randomization.

          -  Current known infection with human immunodeficiency virus (HIV), active hepatitis B
             and/or hepatitis C virus.

          -  History of intolerance (including Grade 3-4 infusion reaction) or hypersensitivity to
             trastuzumab, murine proteins, or docetaxel.

          -  Known hypersensitivity to any of the study drugs, including the excipients, or any
             drugs formulated in polysorbate 80.

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