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NCT04539938 · ClinicalTrials.gov registry record · Phase 2
A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer
A Phase 2 study, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
NCT04539938: Completed Phase 2 study, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
NCT04539938 is a Phase 2 study that has completed, run by Seagen, a wholly owned subsidiary of Pfizer. The registered enrollment target is 70 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04539938, a Phase 2 study, has completed, sponsored by Seagen, a wholly owned subsidiary of Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
Study Summary
This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan (T-DXd). It will also look at what side effects happen when these drugs are given together. A side effect is anything a drug does besides treating cancer. Participants in this trial have HER2-positive (HER2+) breast cancer that has either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and T-DXd.
Primary Outcome
Confirmed objective response rate was defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) per investigator according to RECIST v1.1. For a response to be considered confirmed, the subsequent response had to be at least 4 weeks after the initial response. CR: disappearance of all target lesions and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters
Interventions
- DRUG tucatinib
- DRUG trastuzumab deruxtecan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2020-12-01 |
| Est. Completion | 2025-03-07 |
| Phase | Phase 2 |
What the finished NCT04539938 record still lists
NCT04539938 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 2 interventions - of which tucatinib is the first listed.
NCT04539938 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04539938 about?
NCT04539938 is a clinical study titled "A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer". This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan (T-DXd). It will also look at what side effects happen when these drugs are given together. A side effect is anything a drug does besides treating cancer. Participants in this trial have HER2-positive (HER2+...
What is the current status of trial NCT04539938?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2020-12-01. Estimated completion is 2025-03-07.
What interventions are being tested in trial NCT04539938?
The interventions under investigation include: tucatinib (DRUG), trastuzumab deruxtecan (DRUG).
Who is sponsoring clinical trial NCT04539938?
This trial is sponsored by Seagen, a wholly owned subsidiary of Pfizer, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04539938's enrollment target sits among peer trials
70 937th of 2000 higher than 1,036 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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