Phase II Placebo-controlled Trial of Lisinopril and Coreg CR® to Reduce Cardiotoxicity in Patients With Breast Cancer Receiving (Neo)Adjuvant Chemotherapy With Trastuzumab (Herceptin®)
Phase II Placebo-controlled Trial of Lisinopril and Coreg CR® to Reduce Cardiotoxicity in Patients With Breast Cancer Receiving (Neo)Adjuvant Chemotherapy With Trastuzumab (Herceptin®)
RATIONALE: Lisinopril or Coreg CR®, may help reduce side effects caused by trastuzumab. It is not yet known whether lisinopril or Coreg CR® are more effective than a placebo in reducing side effects caused by trastuzumab.
PURPOSE: This phase II trial is studying lisinopril and Coreg CR® to see how well they work compared with a placebo in reducing side effects in patients with HER2-positive breast cancer receiving trastuzumab.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to chemotherapy comprising an anthracycline (yes vs no). Patients are randomized to 1 of 3 treatment arms.
In all arms, study treatment begins with the first dose of trastuzumab and continues for up to 52 weeks or until the end of trastuzumab therapy.
Quality of life is assessed using the EORTC QLQ-C30 questionnaire at baseline, at 52 weeks (or at the end of trastuzumab therapy), and at 18 and 24 months (or 6 and 12 months after the completion of trastuzumab).
After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months.
INCLUSION CRITERIA
EXCLUSION CRITERIA:
Long Beach, California 90806, United States
Lakeland, Florida 33805, United States
Savannah, Georgia 31405, United States
Ottawa, Illinois 61350, United States
La Porte, Indiana 46350, United States
Des Moines, Iowa 50309, United States
Des Moines, Iowa 50314, United States
Lexington, Kentucky 40536-0093, United States
Southfield, Michigan 48075, United States
Minneapolis, Minnesota 55407, United States
Robbinsdale, Minnesota 55422-2900, United States
Billings, Montana 59102, United States
Lebanon, New Hampshire 03756-0002, United States
Englewood, New Jersey 07631, United States
Vineland, New Jersey 08360, United States
Albuquerque, New Mexico 87110, United States
Cooperstown, New York 13326, United States
Staten Island, New York 10305, United States
Wright-Patterson Air Force Base, Ohio 45433-5529, United States
Wilkes-Barre, Pennsylvania 18711, United States
Green Bay, Wisconsin 54301-3526, United States