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NCT04457596 · ClinicalTrials.gov registry record · Phase 3
T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial
A Phase 3 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, sponsored by Alliance for Clinical Trials in Oncology.
- Active
- Registry status
- Phase 3
- Development phase
- 1,056
- Enrollment target
- 20
- Study locations
NCT04457596: Active Phase 3 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, sponsored by Alliance for Clinical Trials in Oncology.
NCT04457596 is a Phase 3 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8 that is active but no longer recruiting, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 1,056 participants, above the 292-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (262% higher). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04457596, a Phase 3 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, is active but no longer recruiting, sponsored by Alliance for Clinical Trials in Oncology.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,056 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone.
Primary Outcome
A Kaplan-Meier method will be used to estimate the survival curves and a stratified log-rank test will be used to compare the invasive disease-free survival (iDFS) of the two arms. A stratified Cox model will be used to estimate the hazard ratio. If there appears to be clinically significant imbalances of baseline variables between the treatment arms, a secondary analysis of the primary endpoint will use stratified Cox model to compare the treatment effects that include the variables that are de
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- DRUG Placebo Administration
- DRUG Tucatinib
- BIOLOGICAL Trastuzumab Emtansine
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
Arizona
- Banner MD Anderson Cancer Center - Gilbert
- Kingman Regional Medical Center - Kingman
- Cancer Center at Saint Joseph's - Phoenix
- Banner-University Medical Center Phoenix - Phoenix
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
- University of Arkansas for Medical Sciences - Little Rock
Alabama
- University of Alabama at Birmingham Cancer Center - Birmingham
- Thomas Hospital - Fairhope
- Mobile Infirmary Medical Center - Mobile
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,056 participants |
| Start Date | 2021-03-02 |
| Est. Completion | 2035-05-31 |
| Phase | Phase 3 |
What the registry record for NCT04457596 still lists
NCT04457596 is an interventional study that assigns participants to a tested intervention. Its 1,056 participants enrollment target places it among the larger protocols in the corpus, above the 292-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (262% higher).
The record links to 10 conditions, with Anatomic Stage III Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04457596 names 20 study sites across 4 states, led by Alaska, Arizona, Arkansas.
Frequently Asked Questions
What is clinical trial NCT04457596 about?
NCT04457596 is a clinical study titled "T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial". This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Tras...
What is the current status of trial NCT04457596?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,056 participants. The study started on 2021-03-02. Estimated completion is 2035-05-31.
What conditions does trial NCT04457596 study?
This clinical trial studies the following conditions: Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Invasive Breast Carcinoma, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8.
What interventions are being tested in trial NCT04457596?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Placebo Administration (DRUG), Tucatinib (DRUG), Trastuzumab Emtansine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04457596?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04457596 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04457596's enrollment target sits among peer trials
1,056 10th of 84 higher than 75 of 84 other Anatomic Stage III Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage III Breast Cancer AJCC v8 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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