A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer
Completed · Phase 2 · Has a placebo group
Conditions studied: HER2 Positive Breast Cancer
In brief
This study is being done to see if tucatinib works better than placebo 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. All patients in the study will get capecitabine and trastuzumab, two drugs that are often used to treat this cancer. There are two parts to this study. The first part of the study is already complete. Patients were randomly assigned to get either tucatinib or placebo (a pill with no medicine). Since this part was "blinded," neither patients nor their doctors knew whether a patient got tucatinib or placebo. The second part of the study is called the Unblinded Phase. In this part of the study, participants and their doctors know which drugs are being given. Participants who used to get or are currently getting placebo may be able to start taking tucatinib instead. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills two times every day. They will swallow capecitabine pills two times a day during the first two weeks of each cycle. Patients will get trastuzumab injections from the study site staff on the first day of every cycle.
Key facts
- Study ID
- NCT02614794
- Run by
- Seagen Inc.
- People needed
- 612
- Starts
- 2016-01-28
- Expected to finish
- 2022-08-11
- Last updated by the study team
- 2023-08-14
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
- Cancer Treatment Centers of America - Phoenix — Goodyear, Arizona, United States
- Arizona Oncology Associates, PC - HAL — Phoenix, Arizona, United States
- City of Hope National Medical Center — Duarte, California, United States
- TRIO - Central Regulatory Office — Los Angeles, California, United States
- UCLA Medical Center / David Geffen School of Medicine — Los Angeles, California, United States
- Torrance Memorial Physician Network - TRIO — Redondo Beach, California, United States
- University of California at San Francisco — San Francisco, California, United States
- Kaiser Permanente San Marcos Medical Offices — San Marcos, California, United States
- Central Coast Medical Oncology Corporation TRIO — Santa Maria, California, United States
- Kaiser Permanente Medical Center Northern California — Vallejo, California, United States
- University of Colorado Hospital / University of Colorado — Aurora, Colorado, United States
- Yale Cancer Center — New Haven, Connecticut, United States
- Lombardi Cancer Center / Georgetown University Medical Center — Washington D.C., District of Columbia, United States
- Florida Cancer Specialists - South Region — Fort Myers, Florida, United States
- Memorial Regional Hospital TRIO — Hollywood, Florida, United States
- Baptist MD Anderson Cancer Center — Jacksonville, Florida, United States
- University of Miami — Miami, Florida, United States
- Mount Sinai Medical Center / Florida — Miami Beach, Florida, United States
- Orlando Health, Inc. TRIO — Orlando, Florida, United States
- Florida Cancer Specialists - North Region — St. Petersburg, Florida, United States
- H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
- Florida Cancer Specialists - East West Palm Beach, FL (SCRI) — West Palm Beach, Florida, United States
- Winship Cancer Institute / Emory University School of Medicine — Atlanta, Georgia, United States
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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