A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Patients With HER2-Positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-Directed Therapy (TH3RESA)
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/30/2013 |
| Start Date: | September 2011 |
| End Date: | October 2015 |
| Contact: | Please reference Study ID Number: TDM4997g www.roche.com/about_roche/roche_worldwide.htm |
| Email: | genentechclinicaltrials@druginfo.com |
| Phone: | 888-662-6728 (U.S. Only) |
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
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. This study is
also known under Roche study protocol number BO25734.
Inclusion Criteria:
- 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 trastuzumab, a taxane, and lapatinib
- 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
Exclusion Criteria:
- 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 corticosteroid therapy to control symptoms within 1 month of randomization
We found this trial at
32
sites
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