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NCT03054363 · ClinicalTrials.gov registry record · Phase 1
Tucatinib, Palbociclib and Letrozole in Metastatic Hormone Receptor Positive and HER2-positive Breast Cancer
A Phase 1 study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
NCT03054363: Completed Phase 1 study, sponsored by University of Colorado, Denver.
NCT03054363 is a Phase 1 study that has completed, run by University of Colorado, Denver. The registered enrollment target is 42 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03054363, a Phase 1 study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
Study Summary
This is a multicenter run-in phase Ib / roll-over phase II study of triple targeted drug combination (HER2-targeted small molecule inhibitor tucatinib, CDK4/6 inhibitor palbociclib and aromatase inhibitor letrozole) as a first or second line of therapy in patients with metastatic hormone receptor positive and HER2-positive breast cancer.
Primary Outcome
To measure safety and tolerability of tucatinib used in combination with palbociclib and letrozole, we will assess the proportion of subjects experiencing dose-limiting toxicities (DLTs) potentially attributable to tucatinib, palbociclib, or both drugs, and compare them to predefined safety thresholds. DLT was defined as any grade ≥ 3 nonhematologic adverse event, grade 3 neutropenia with fever, grade 3 thrombocytopenia with bleeding, or any hematologic toxicity grade ≥ 4 using NCI CTCAE version
Interventions
- DRUG Tucatinib in Combination with Palbociclib and Letrozole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2017-11-27 |
| Est. Completion | 2023-02-07 |
| Phase | Phase 1 |
What the finished NCT03054363 record still lists
NCT03054363 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 1 intervention - of which Tucatinib in Combination with Palbociclib and Letrozole is the first listed.
NCT03054363 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03054363 about?
NCT03054363 is a clinical study titled "Tucatinib, Palbociclib and Letrozole in Metastatic Hormone Receptor Positive and HER2-positive Breast Cancer". This is a multicenter run-in phase Ib / roll-over phase II study of triple targeted drug combination (HER2-targeted small molecule inhibitor tucatinib, CDK4/6 inhibitor palbociclib and aromatase inhibitor letrozole) as a first or second line of therapy in patients with metastatic hormone receptor po...
What is the current status of trial NCT03054363?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2017-11-27. Estimated completion is 2023-02-07.
What interventions are being tested in trial NCT03054363?
The interventions under investigation include: Tucatinib in Combination with Palbociclib and Letrozole (DRUG).
Who is sponsoring clinical trial NCT03054363?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03054363's enrollment target sits among peer trials
42 1105th of 2000 higher than 876 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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