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Study identifier: NCT03975647 Synced from ClinicalTrials.gov · August 02, 2026
● Active Not Recruiting

A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer

Condition: HER2-positive Breast Cancer  ·  Sponsor: Seagen, a wholly owned subsidiary of Pfizer

PhasePhase 3
Planned participants466
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Locations (490)

University of South Alabama Health Children's and Women's HospitalMobile, Alabama, United States
University of South Alabama Mitchell Cancer InstituteMobile, Alabama, United States
University of South Alabama Health University HospitalMobile, Alabama, United States
Banner Gateway Medical CenterGilbert, Arizona, United States
Banner MD Anderson Cancer CenterGilbert, Arizona, United States
Western Regional Medical Center, LLCGoodyear, Arizona, United States
Arizona Oncology Associates, PC - HOPE.Tucson, Arizona, United States
Arizona Oncology Associates, PC - HOPETucson, Arizona, United States
Arizona Oncology Associates, PC - HOPETucson, Arizona, United States
UCLA Hematology/Oncology - AlhambraAlhambra, California, United States
Kaiser Permanente Medical Center Lab Drawing StationAntioch, California, United States
Kaiser Permanente Medical Center Lab Drawing StationAntioch, California, United States

+ 478 more locations — full list on the registry record.

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