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Brief Title: A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer
Official Title: A Single Arm, Open Label Phase 2 Study of Tucatinib in Combination With Trastuzumab Deruxtecan in Subjects With Previously Treated Unresectable Locally-Advanced or Metastatic HER2+ Breast Cancer
Study ID: NCT04539938
Brief Summary: This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan (T-DXd). It will also look at what side effects happen when these drugs are given together. A side effect is anything a drug does besides treating cancer. Participants in this trial have HER2-positive (HER2+) breast cancer that has either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and T-DXd.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
Arizona Oncology Associates, PC - HOPE, Tucson, Arizona, United States
City of Hope, Duarte, California, United States
UCLA Department of Medicine - Hematology & Oncology, Los Angeles, California, United States
University of California at San Francisco, San Francisco, California, United States
University of Colorado Hospital / University of Colorado, Aurora, Colorado, United States
Lombardi Cancer Center / Georgetown University Medical Center, Washington, District of Columbia, United States
Florida Cancer Specialists - North Region, Saint Petersburg, Florida, United States
Winship Cancer Institute / Emory University School of Medicine, Atlanta, Georgia, United States
Georgia Cancer Specialists / Northside Hospital Cancer Institute, Sandy Springs, Georgia, United States
James Graham Brown Cancer Center / University of Louisville, Louisville, Kentucky, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Allina Health Cancer Institute, Minneapolis, Minnesota, United States
Mayo Clinic Rochester, Rochester, Minnesota, United States
Saint Luke's Cancer Institute LLC, Kansas City, Missouri, United States
HCA Midwest Health Kansas City, Kansas City, Missouri, United States
Nebraska Cancer Specialists, Omaha, Nebraska, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
UNC Lineberger Comprehensive Cancer Center / University of North Carolina, Chapel Hill, North Carolina, United States
Wake Forest Baptist Medical Center / Wake Forest University, Winston-Salem, North Carolina, United States
Providence Portland Medical Center, Portland, Oregon, United States
Northwest Cancer Specialists, P.C., Tigard, Oregon, United States
Magee Womens Hospital of UPMC, Pittsburgh, Pennsylvania, United States
Chattanooga Oncology and Hematology Associates/Tennessee Oncology-Memorial Plaza, Chattanooga, Tennessee, United States
Tennessee Oncology-Nashville/Sarah Cannon Research Institute, Nashville, Tennessee, United States
Texas Oncology - DFW, Dallas, Texas, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
MD Anderson Cancer Center / University of Texas, Houston, Texas, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care, Salem, Virginia, United States
Seattle Cancer Care Alliance / University of Washington, Seattle, Washington, United States
Carbone Cancer Center / University of Wisconsin, Madison, Wisconsin, United States
Name: Jorge Ramos, DO
Affiliation: Seagen Inc.
Role: STUDY_DIRECTOR