a study of trastuzumab emtansine in participants with human epidermal growth factor receptor 2 (her2)-positive breast cancer who have received prior anti-her2 and chemotherapy-based treatment

Conditions: Breast Cancer

Summary: this two-cohort, open-label, multicenter study will assess the safety, efficacy and tolerability of trastuzumab emtansine in participants with her2-positive locally advanced breast cancer (labc) or metastatic breast cancer (mbc) who have received prior anti-her2 and chemotherapy-based treatment. participants in cohort 1 will be drawn from the general participant population; cohort 2 will include only asian participants.


Eligibility criteria:
inclusion criteria: * her2-positive disease determined locally * histologically or cytologically confirmed invasive breast cancer * prior treatment for breast cancer in the adjuvant, unresectable, locally advanced or metastatic setting must include both chemotherapy, alone or in combination with another agent, and an anti-her2 agent, alone or in combination with another agent * documented progression of incurable, unresectable, labc, or mbc, defined by the investigator: progression must occur during or after most recent treatment for labc/mbc or within 6 months of completing adjuvant therapy * measurable and/or non-measurable disease * left ventricular ejection fraction (lvef) \>/=50% by either echocardiogram (echo) or multiple-gated acquisition scan (muga) * eastern cooperative oncology group (ecog) performance status of 0,1 or 2 * adequate organ function * use of highly effective contraception as defined by the protocol exclusion criteria: * history of treatment with trastuzumab emtansine * prior enrollment into a clinical study containing trastuzumab emtansine regardless of having received trastuzumab emtansine or not * peripheral neuropathy of grade \>/= 3 per national cancer institute (nci) common terminology criteria for adverse events (ctcae) v 4.0 * history of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, stage 1 uterine cancer, synchronous or previously diagnosed her2-positive breast cancer * history of receiving any anti-cancer drug/biologic or investigational treatment within 21 days prior to first study treatment except hormone therapy, which can be given up to 7 days prior to first study treatment; recovery of treatment-related toxicity consistent with other eligibility criteria * history of exposure to cumulative doses of anthracyclines * history of radiation therapy within 14 days of first study treatment. the participant must have recovered from any resulting acute toxicity (to grade \</=1) prior to first study treatment. * metastatic central nervous system (cns) disease only * brain metastases which are symptomatic * history of a decrease in lvef to less than (\<) 40% or symptomatic congestive heart failure (chf) with previous trastuzumab treatment * history of symptomatic chf (new york heart association \[nyha\] classes ii-iv) or serious cardiac arrhythmia requiring treatment * history of myocardial infarction or unstable angina within 6 months of first study treatment * current dyspnea at rest due to complications of advanced malignancy or requirement for continuous oxygen therapy * current severe, uncontrolled systemic disease (clinically significant cardiovascular, pulmonary, or metabolic disease) * pregnancy or lactation * currently known active infection with human immunodeficiency virus (hiv), hepatitis b virus, or hepatitis c virus * history of intolerance (such as grade 3-4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins or any component of the product