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Brief Title: Study of CR011-vcMMAE to Treat Locally Advanced or Metastatic Breast Cancer
Official Title: A Phase I/II Study of CR011-vcMMAE in Patients With Locally Advanced or Metastatic Breast Cancer
Study ID: NCT00704158
Brief Summary: This study will evaluate the safety and tolerability of CR011-vcMMAE in patients with locally advanced and metastatic breast cancer. CR011-vcMMAE will be administered intravenously (IV) once every 3 weeks (q3w) to cohorts of 3-6 patients to confirm the maximum tolerated dose (MTD) in breast cancer patients. Once the MTD is confirmed, up to 25 patients with locally advanced or metastatic breast cancer will be enrolled into the Phase II portion of the trial to further evaluate the safety and efficacy of CR011-vcMMAE.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Florida Cancer Specialists, Ft. Myers, Florida, United States
Hematology Oncology Associates, Lake Worth, Florida, United States
Georgia Cancer Specialists, Atlanta, Georgia, United States
Cornell University, New York, New York, United States
Tennessee Oncology, Nashville, Tennessee, United States