A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer
- Conditions
- HER2 Positive Breast Cancer
- Interventions
- Registration Number
- NCT04539938
- Lead Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- 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
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 70
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm tucatinib Tucatinib + trastuzumab deruxtecan Single Arm trastuzumab deruxtecan Tucatinib + trastuzumab deruxtecan
- Primary Outcome Measures
Name Time Method Confirmed objective response rate (cORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 according to investigator assessment From start of treatment up to approximately 3 years ORR is defined as the proportion of subjects with confirmed complete response (CR) or partial response (PR) per RECIST v1.1
- Secondary Outcome Measures
Name Time Method Incidence of treatment discontinuations From start of treatment up to approximately 3 years Duration of response (DOR) per RECIST v1.1 according to investigator assessment From start of treatment up to approximately 3 years DOR is defined as the time from first documentation of objective response to the first documentation of disease progression per RECIST v1.1 or death from any cause, whichever occurs earlier
Progression-free survival (PFS) per RECIST v1.1 according to investigator assessment From start of treatment up to approximately 3 years PFS is defined as the time from start of study treatment to first documentation of tumor progression or to death due to any cause, whichever comes first
Disease control rate (DCR) per RECIST v1.1 according to investigator assessment From start of treatment up to approximately 3 years DCR is defined as the proportion of subjects with confirmed CR, PR or stable disease according to RECIST v1.1
Overall survival (OS) From start of treatment up to approximately 5 years OS is defined as the time from treatment initiation to death due to any cause
Incidence of adverse events (AEs) From start of treatment up to approximately 3 years An AE is defined as any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
Incidence of laboratory abnormalities From start of treatment up to approximately 3 years Incidence of dose modifications From start of treatment up to approximately 3 years
Related Research Topics
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Trial Locations
- Locations (33)
UCLA Department of Medicine - Hematology & Oncology
🇺🇸Los Angeles, California, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Seattle Cancer Care Alliance / University of Washington
🇺🇸Seattle, Washington, United States
MD Anderson Cancer Center / University of Texas
🇺🇸Houston, Texas, United States
Allina Health Cancer Institute
🇺🇸Minneapolis, Minnesota, United States
University of California at San Francisco
🇺🇸San Francisco, California, United States
Tennessee Oncology-Nashville/Sarah Cannon Research Institute
🇺🇸Nashville, Tennessee, United States
Arizona Oncology Associates, PC - HOPE
🇺🇸Tucson, Arizona, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
Nebraska Cancer Specialists
🇺🇸Omaha, Nebraska, United States
City of Hope
🇺🇸Duarte, California, 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
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Northwest Cancer Specialists, P.C.
🇺🇸Tigard, Oregon, United States
Texas Oncology - DFW
🇺🇸Dallas, Texas, United States
Carbone Cancer Center / University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care
🇺🇸Salem, Virginia, United States
Chattanooga Oncology and Hematology Associates/Tennessee Oncology-Memorial Plaza
🇺🇸Chattanooga, Tennessee, United States
Virginia Cancer Specialists, PC
🇺🇸Fairfax, Virginia, United States
Georgia Cancer Specialists / Northside Hospital Cancer Institute
🇺🇸Sandy Springs, Georgia, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Magee Womens Hospital of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
University of Colorado Hospital / University of Colorado
🇺🇸Aurora, Colorado, United States
James Graham Brown Cancer Center / University of Louisville
🇺🇸Louisville, Kentucky, United States
Wake Forest Baptist Medical Center / Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Saint Luke's Cancer Institute LLC
🇺🇸Kansas City, Missouri, United States
HCA Midwest Health Kansas City
🇺🇸Kansas City, Missouri, United States
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
🇺🇸Chapel Hill, North Carolina, United States