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A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer
NCT02614794 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02614794
The ClinicalTrials.gov registry entry for NCT02614794 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 612 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seagen, which has 12 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02614794 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02614794?
The interventions under investigation include: placebo (DRUG), tucatinib (DRUG), trastuzumab (DRUG), capecitabine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02614794?
This trial is sponsored by Seagen, which has 12 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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