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NCT03975647 · ClinicalTrials.gov registry record · Phase 3
A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer
A Phase 3 study of HER2-positive Breast Cancer, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
- Active
- Registry status
- Phase 3
- Development phase
- 466
- Enrollment target
- 20
- Study locations
NCT03975647 is a Phase 3 study of HER2-positive Breast Cancer that is active but no longer recruiting, run by Seagen, a wholly owned subsidiary of Pfizer. The registered enrollment target is 466 participants, above the 231-participant average among 54 other HER2-positive Breast Cancer trials with a reported enrollment target (102% higher). The trial reports 20 study locations across 3 states.
The verdict
NCT03975647, a Phase 3 study of HER2-positive Breast Cancer, is active but no longer recruiting, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 466 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG placebo
- DRUG T-DM1
- DRUG tucatinib
Study Locations (20)
California
- UCLA Hematology/Oncology - Alhambra - Alhambra
- Kaiser Permanente Medical Center Lab Drawing Station - Antioch
- Kaiser Permanente Medical Center Lab Drawing Station - Antioch
- UCLA Hematology/Oncology- Beverly Hills - Beverly Hills
- UC Irvine Health Cancer Center - Newport - Costa Mesa
- City of Hope Investigational Drug Services (IDS) - Duarte
- City of Hope(City of Hope National Medical Center,City of Hope Medical Center) - Duarte
- Kaiser Permanente Medical Center (Radiology) - Dublin
- UCLA Hematology/Oncology - Encino - Encino
- Kaiser Permanente Medical Center Lab Drawing Station - Fairfield
- Kaiser Permanente Medical Center Lab Drawing Station - Gilroy
Arizona
- Banner Gateway Medical Center - Gilbert
- Banner MD Anderson Cancer Center - Gilbert
- Western Regional Medical Center, LLC - Goodyear
- Arizona Oncology Associates, PC - HOPE. - Tucson
- Arizona Oncology Associates, PC - HOPE - Tucson
- Arizona Oncology Associates, PC - HOPE - Tucson
Alabama
- University of South Alabama Health Children's and Women's Hospital - Mobile
- University of South Alabama Mitchell Cancer Institute - Mobile
- University of South Alabama Health University Hospital - Mobile
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 466 participants |
| Start Date | 2019-10-02 |
| Est. Completion | 2029-03-10 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03975647
The ClinicalTrials.gov registry entry for NCT03975647 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 466 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 231-participant average among 54 other HER2-positive Breast Cancer trials with a reported enrollment target (102% higher). The listed sponsor is Seagen, a wholly owned subsidiary of Pfizer, which has 28 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with HER2-positive Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which placebo is the first listed.
NCT03975647 reports 20 study locations spanning 3 distinct geographic areas - top geographies include California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT03975647 about?
NCT03975647 is a clinical study titled "A Study of Tucatinib vs. Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Patients With Advanced or Metastatic HER2+ Breast Cancer". 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 bod...
What is the current status of trial NCT03975647?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 466 participants. The study started on 2019-10-02. Estimated completion is 2029-03-10.
What conditions does trial NCT03975647 study?
This clinical trial studies the following conditions: HER2-positive Breast Cancer.
What interventions are being tested in trial NCT03975647?
The interventions under investigation include: placebo (DRUG), T-DM1 (DRUG), tucatinib (DRUG).
Who is sponsoring clinical trial NCT03975647?
This trial is sponsored by Seagen, a wholly owned subsidiary of Pfizer, which has 28 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03975647 being conducted?
This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.