A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: HER2-positive Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT03975647
- Run by
- Seagen, a wholly owned subsidiary of Pfizer
- People needed
- 466
- Starts
- 2019-10-02
- Expected to finish
- 2029-03-10
- Last updated by the study team
- 2026-07-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of South Alabama Mitchell Cancer Institute — Mobile, Alabama, United States
- University of South Alabama Health University Hospital — Mobile, Alabama, United States
- Banner Gateway Medical Center — Gilbert, Arizona, United States
- Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
- Western Regional Medical Center, LLC — Goodyear, Arizona, United States
- Arizona Oncology Associates, PC - HOPE. — Tucson, Arizona, United States
- Arizona Oncology Associates, PC - HOPE — Tucson, Arizona, United States
- Arizona Oncology Associates, PC - HOPE — Tucson, Arizona, United States
- UCLA Hematology/Oncology - Alhambra — Alhambra, California, United States
- Kaiser Permanente Medical Center Lab Drawing Station — Antioch, California, United States
- Kaiser Permanente Medical Center Lab Drawing Station — Antioch, California, United States
- UCLA Hematology/Oncology- Beverly Hills — Beverly Hills, California, United States
- UC Irvine Health Cancer Center - Newport — Costa Mesa, California, United States
- City of Hope Investigational Drug Services (IDS) — Duarte, California, United States
- City of Hope(City of Hope National Medical Center,City of Hope Medical Center) — Duarte, California, United States
- Kaiser Permanente Medical Center (Radiology) — Dublin, California, United States
- UCLA Hematology/Oncology - Encino — Encino, California, United States
- Kaiser Permanente Medical Center Lab Drawing Station — Fairfield, California, United States
- Kaiser Permanente Medical Center Lab Drawing Station — Gilroy, California, United States
- UCLA Hematology/Oncology- Irvine — Irvine, California, United States
- Drug Management Only: UCLA West Medical Pharmacy, Attn: Steven L Wong, Pharm.D. — Los Angeles, California, United States
- Regulatory Management only: TRIO-US Central Administration — Los Angeles, California, United States
- Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
- UCLA Hematology/Oncology — Los Angeles, California, United States
- University of South Alabama Health Children's and Women's Hospital — Mobile, Alabama, United States
Full record on ClinicalTrials.gov
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