a study of trastuzumab-mcc-dm1 administered intravenously to patients with her2-positive metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: study of trastuzumab emtansine (t-dm1) administered to patients with human epidermal growth factor receptor 2 (her2)-positive metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * signed study-specific informed consent form(s) * age ≥ 18 years * histologically documented breast cancer * her2-positive disease * metastatic breast cancer * disease progression on the last chemotherapy regimen received in the metastatic setting * prior treatment with an anthracycline, trastuzumab, a taxane, lapatinib, and capecitabine in the neoadjuvant, adjuvant, locally advanced, or metastatic setting and prior treatment with at least two lines of therapy (a line of therapy can be a combination of two agents or single-agent chemotherapy) in the metastatic setting * at least two lines of anti-her2 therapy must have been given in the metastatic setting as monotherapy or combined with chemotherapy or hormonal therapy. the her2-targeted agent can include trastuzumab, lapatinib, or an investigational agent with her2-inhibitory activity. * a minimum of 6 weeks of trastuzumab for the treatment of metastatic disease is required * patients must have had at least 14 days of exposure in the metastatic setting to lapatinib and capecitabine (given together or separately) unless they were intolerant of lapatinib and/or capecitabine exclusion criteria: * chemotherapy ≤ 21 days before enrollment * trastuzumab ≤ 21 days before enrollment * hormone therapy ≤ 7 days before enrollment * granulocyte-stimulating agent \< 14 days before enrollment * investigational therapy ≤ 28 days before enrollment * previous radiotherapy for treatment of metastatic breast cancer ≤ 21 days before enrollment * 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 3 months of the first study treatment * history of intolerance (including grade 3-4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins * history of exposure to the following cumulative doses of anthracyclines: doxorubicin or liposomal doxorubicin \> 500 mg/m\^2; epirubicin \> 900 mg/m\^2; mitoxantrone \> 120 mg/m\^2 and idarubicin \> 90 mg/m\^2 * peripheral neuropathy of grade ≥ 3 per national cancer institute common terminology criteria for adverse events (nci ctcae), v3.0 * history of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma * current unstable angina * history of symptomatic congestive heart failure (chf), or ventricular arrhythmia requiring treatment * history of myocardial infarction within 6 months of enrollment * left ventricular ejection fraction (lvef) \< 50% within 28 days of enrollment * history of decreased lvef to \< 50% or symptomatic chf with previous adjuvant trastuzumab treatment * severe dyspnea at rest due to complications of advanced malignancy or requiring current continuous oxygen therapy * current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease) * major surgical procedure or significant traumatic injury within 28 days before enrollment or anticipation of the need for major surgery during the course of study treatment * current pregnancy or lactation * current known infection with human immunodeficiency virus (hiv), active hepatitis b, and/or hepatitis c virus * assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol

Keywords: her2-positive breast cancer her2 mbc trastuzumab emtansine