Spots Global Cancer Trial Database for Tucatinib, Trastuzumab, and Capecitabine for the Treatment of HER2+ LMD
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Trial Identification
Brief Title: Tucatinib, Trastuzumab, and Capecitabine for the Treatment of HER2+ LMD
Official Title: A Phase II Non-randomized Study to Assess the Safety and Efficacy of the Combination of Tucatinib and Trastuzumab and Capecitabine for Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer
Study ID: NCT03501979
Study Description
Brief Summary: A phase 2 non-randomized study to assess the safety and efficacy of the combination of tucatinib and trastuzumab with capecitabine for the treatment of leptomeningeal metastases in HER2-neu positive breast cancer.
Detailed Description: The purpose of this study is to evaluate a new treatment for patients with HER2+ metastatic breast cancer (MBC) with leptomeningeal disease (LMD). This is a rare and fast-growing form of cancer. Leptomeningeal disease refers to the seeding of tumor cells to the leptomeninges and dissemination in the cerebrospinal fluid. Currently, there are is no standard of care treatment for LMD. However, we think the combination therapy will be safe and well-tolerated and may also improve survival. Blood and spinal fluid samples will be collected to evaluate the effects on the body and the cancer, which will help provide greater understanding to therapy response in patients. The study has a two-stage design with the first stage including 15 subjects from up to ten institutions nationwide. If it advances to the second stage based on the number of successes, another 15 subjects will be enrolled.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
UCSF-Mission Bay, San Francisco, California, United States
MedStar Georgetown University-Lombardi CCC, Washington, District of Columbia, United States
University of Chicago, Chicago, Illinois, United States
Indiana University-Melvin and Bren Simon cancer center, Indianapolis, Indiana, United States
Dana Farber/Harvard Cancer Center-, Boston, Massachusetts, United States
University of Michigan-, Ann Arbor, Michigan, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
University of Washington Medical Center-Montlake, Seattle, Washington, United States
Contact Details
Name: Erica M Stringer-Reasor, MD
Affiliation: University of Alabama at Birmingham
Role: PRINCIPAL_INVESTIGATOR
Name: Rashmi K Murthy, MD, MBE
Affiliation: M.D. Anderson Cancer Center
Role: STUDY_CHAIR
Name: Barbara J O'Brien, MD
Affiliation: M.D. Anderson Cancer Center
Role: STUDY_CHAIR
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