Spots Global Cancer Trial Database for T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer
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Trial Identification
Brief Title: T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer
Official Title: A Single Arm Phase II Study to Evaluate Efficacy of T-DM1 With Palbociclib in the Treatment of Patients With Metastatic HER2 Positive Breast Cancer
Study ID: NCT03530696
Study Description
Brief Summary: This is a single arm, phase II study to evaluate if the combination of T-DM1 with palbociclib improves progression-free survival in patients with metastatic HER2 positive breast cancer. All patients will be treated with T-DM1 with palbociclib.
Detailed Description: This is a multi-center, single arm, phase II study of T-DM1 with palbociclib in the treatment of patients with metastatic HER2-positive breast cancer. Hypotheses: Combination of T-DM1 with palbociclib improves progression free survival Primary objective: Progression free survival of the combination of T-DM1 with palbociclib Secondary objectives i) Response rates ii) Overall survival Correlative objectives i) Investigate predictive biomarkers of response in blood and archived tumor tissue ii) Investigate mechanisms of resistance for palbociclib in blood and tumor tissue
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Arizona Cancer Center, Tucson, Arizona, United States
Cedar-Sinai, Beverly Hills, California, United States
University of Colorado Denver, Aurora, Colorado, United States
Yale Cancer Center, New Haven, Connecticut, United States
Johns Hopkins Hospital, Baltimore, Maryland, United States
Mosaic Life Care, Saint Joseph, Missouri, United States
University of New Mexico, Albuquerque, New Mexico, United States
Roswell Park Comprehensive Cancer center, Buffalo, New York, United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
Cleveland Clinic, Cleveland, Ohio, United States
Oregon Health and Sciences University, Portland, Oregon, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
JPS Health Network, Fort Worth, Texas, United States
Swedish Cancer Institute, Seattle, Washington, United States
University of Washington, Seattle, Washington, United States
University of Wisconsin, Madison, Wisconsin, United States
Contact Details
Name: Pavani Chalasani, MD
Affiliation: The University of Arizona Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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