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 Reg

Status
Active
Cancer Type
Breast Cancer
Trial Phase
Phase III
Eligibility
18 and over, Male and Female
Study Type
Treatment
NCD ID
NCT01419197
Protocol IDs
TDM4997g (primary)
2011-000509-29
BO25734
Study Sponsor
Genentech Incorporated

Summary

This randomized, multicenter, two-arm, open-label study 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.