|Closed||Breast Cancer||Phase III||NCT01419197|
This randomized, multicenter, two-arm, open-label study (TH3RESA) will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) in comparison with treatment of the physician's choice in patients with metastatic or unresectable locally advanced/recurrent HER2-positive breast cancer. Eligible patients will be randomized to receive either T-DM1 3.6 mg/kg intravenously every 21 days or treatment of the physician's choice. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
- Adult patients, >/= 18 years of age
- Histologically or cytologically documented breast cancer
- Metastatic or unresectable locally advanced/recurrent breast cancer
- HER2-positive disease by prospective laboratory confirmation
- Disease progression on the last regimen received as defined by the investigator
- Prior treatment with an anthracycline, trastuzumab, a taxane, lapatinib, and capecitabine
- Disease progression after at least two regimens of HER2-directed therapy in the metastatic or unresectable locally advanced/recurrent setting
- Adequate organ function, as evidenced by laboratory results
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- LVEF >/= 50% by ECHO or MUGA
- Prior enrolment in a T-DM1 containing study, regardless whether the patient received prior T-DM1
- Brain metastases that are untreated or symptomatic, or require any radiation, surgery or steroid therapy to control symptoms within 2 months of randomization
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
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