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SCCA Breast Cancer Clinical Trials

Trastuzumab Emtansine (T-DM1) for HER2-Positive Breast Cancer (UW11034)
A Phase III Randomized, Multicenter, Two-Arm, Open-Label Trial to Evaluate the Efficacy of Trastuzumab Emtansine Compared With Treatment of Physician's Choice in Patients With HER2 Positive Metastatic Breast Cancer Who Have Received at Least Two Prior Regimens of HER2 Directed Therapy
Status Conditions Phase Study ID
Closed Breast Cancer Phase III NCT01419197
Summary

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.


Investigator
V.K. Gadi, MD, PhD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • 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
Exclusions (conditions that would prevent participation in this study)
  • Chemotherapy
  • Trastuzumab
  • Lapatinib
  • 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
Last Updated
February 11, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.