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NCT02614794 · ClinicalTrials.gov registry record · Phase 2
A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer
A Phase 2 study of HER2-positive Breast Cancer, sponsored by Seagen.
- Completed
- Registry status
- Phase 2
- Development phase
- 612
- Enrollment target
- 20
- Study locations
NCT02614794: Completed Phase 2 study of HER2-positive Breast Cancer, sponsored by Seagen.
NCT02614794 is a Phase 2 study of HER2-positive Breast Cancer that has completed, run by Seagen. The registered enrollment target is 612 participants, above the 225-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (172% higher). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02614794, a Phase 2 study of HER2-positive Breast Cancer, has completed, sponsored by Seagen.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 612 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Defined as the time from the date of randomization to the date of documented disease progression.
Conditions Studied
Interventions
- DRUG placebo
- DRUG tucatinib
- DRUG trastuzumab
- DRUG capecitabine
Study Locations (20)
California
- City of Hope National Medical Center - Duarte
- TRIO - Central Regulatory Office - Los Angeles
- UCLA Medical Center / David Geffen School of Medicine - Los Angeles
- Torrance Memorial Physician Network - TRIO - Redondo Beach
- University of California at San Francisco - San Francisco
- Kaiser Permanente San Marcos Medical Offices - San Marcos
- Central Coast Medical Oncology Corporation TRIO - Santa Maria
- Kaiser Permanente Medical Center Northern California - Vallejo
Florida
- Florida Cancer Specialists - South Region - Fort Myers
- Memorial Regional Hospital TRIO - Hollywood
- Baptist MD Anderson Cancer Center - Jacksonville
- University of Miami - Miami
- Mount Sinai Medical Center / Florida - Miami Beach
Alabama
- University of Alabama at Birmingham - Birmingham
- University of South Alabama - Mitchell Cancer Institute - Mobile
Arizona
- Cancer Treatment Centers of America - Phoenix - Goodyear
- Arizona Oncology Associates, PC - HAL - Phoenix
Colorado
- University of Colorado Hospital / University of Colorado - Aurora
Connecticut
- Yale Cancer Center - New Haven
District of Columbia
- Lombardi Cancer Center / Georgetown University Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 612 participants |
| Start Date | 2016-01-28 |
| Est. Completion | 2022-08-11 |
| Phase | Phase 2 |
What the finished NCT02614794 record still lists
NCT02614794 is an interventional study that assigns participants to a tested intervention. The registered 612 participants enrollment target is mid-sized for trials with a published cap, above the 225-participant average among 58 other HER2-positive Breast Cancer trials with a reported enrollment target (172% higher).
The record links to 1 condition, with HER2-positive Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which placebo is the first listed.
NCT02614794 names 20 study sites across 7 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT02614794 about?
NCT02614794 is a clinical study titled "A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer". 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 sur...
What is the current status of trial NCT02614794?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 612 participants. The study started on 2016-01-28. Estimated completion is 2022-08-11.
What conditions does trial NCT02614794 study?
This clinical trial studies the following conditions: HER2-positive Breast Cancer.
What interventions are being tested in trial NCT02614794?
The interventions under investigation include: placebo (DRUG), tucatinib (DRUG), trastuzumab (DRUG), capecitabine (DRUG).
Who is sponsoring clinical trial NCT02614794?
This trial is sponsored by Seagen, which has 84 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02614794 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HER2-positive Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02614794's enrollment target sits among peer trials
612 4th of 58 higher than 55 of 58 other HER2-positive Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HER2-positive Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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