Status:
COMPLETED
A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Participants With HER2-positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-directed Therapy
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This randomized, multicenter, 2-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 partici...
Eligibility Criteria
Inclusion
- Adult participants ≥ 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.
- Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram or multi gated acquisition scan.
Exclusion
- Chemotherapy ≤ 21 days before first study treatment.
- Trastuzumab ≤ 21 days before first study treatment.
- Lapatinib ≤ 14 days before first study treatment.
- Prior enrollment in a trastuzumab emtansine containing study, regardless whether the patient received prior trastuzumab emtansine.
- Brain metastases that are untreated or symptomatic, or require any radiation, surgery or corticosteroid therapy to control symptoms within 1 month of randomization.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
602 Patients enrolled
Trial Details
Trial ID
NCT01419197
Start Date
September 1 2011
End Date
August 1 2015
Last Update
October 12 2016
Active Locations (184)
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1
Tucson, Arizona, United States, 85704
2
Hot Springs, Arkansas, United States, 71913
3
Hayward, California, United States, 94545
4
Highland, California, United States, 92346