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NCT05230810 · ClinicalTrials.gov registry record · Phase 1
Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer.
A Phase 1 study of HER2-positive Metastatic Breast Cancer, sponsored by Criterium.
- Active
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 4
- Study locations
NCT05230810: Active Phase 1 study of HER2-positive Metastatic Breast Cancer, sponsored by Criterium.
NCT05230810 is a Phase 1 study of HER2-positive Metastatic Breast Cancer that is active but no longer recruiting, run by Criterium. The registered enrollment target is 40 participants, below the 121-participant average among 11 other HER2-positive Metastatic Breast Cancer trials with a reported enrollment target (67% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05230810, a Phase 1 study of HER2-positive Metastatic Breast Cancer, is active but no longer recruiting, sponsored by Criterium.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 4
- Study locations
Study Summary
Phase IB/II clinical trial of Alpelisb and Tucatinib in patients with PIK3CA-Mutant HER2-positive metastatic breast cancer.
Primary Outcome
MTD of tucatinib and alpelisib in combination, summary of all AEs and SAEs on study as evaluated by NCI-CTCAE v 5.0
Conditions Studied
Interventions
- DRUG Fulvestrant
- DRUG Tucatinib
- DRUG Alpelisib
Study Locations (4)
Colorado
- University of Colorado Cancer Center - Aurora
- Cancer Care & Hematology-Fort Collins - Fort Collins
Louisiana
- Louisiana State University Health Sciences Center - New Orleans
Wisconsin
- University of Wisconsin Carbone Cancer Center - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-08-25 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
What the registry record for NCT05230810 still lists
NCT05230810 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 121-participant average among 11 other HER2-positive Metastatic Breast Cancer trials with a reported enrollment target (67% lower).
The record links to 1 condition, with HER2-positive Metastatic Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Fulvestrant is the first listed.
NCT05230810 reports a single indexed study location in Colorado, Louisiana, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT05230810 about?
NCT05230810 is a clinical study titled "Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer.". Phase IB/II clinical trial of Alpelisb and Tucatinib in patients with PIK3CA-Mutant HER2-positive metastatic breast cancer.
What is the current status of trial NCT05230810?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2022-08-25. Estimated completion is 2026-06-30.
What conditions does trial NCT05230810 study?
This clinical trial studies the following conditions: HER2-positive Metastatic Breast Cancer.
What interventions are being tested in trial NCT05230810?
The interventions under investigation include: Fulvestrant (DRUG), Tucatinib (DRUG), Alpelisib (DRUG).
Who is sponsoring clinical trial NCT05230810?
This trial is sponsored by Criterium, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05230810 being conducted?
This trial has 4 study locations across Colorado, Louisiana, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HER2-positive Metastatic Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05230810's enrollment target sits among peer trials
40 9th of 11 higher than 3 of 11 other HER2-positive Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HER2-positive Metastatic Breast Cancer 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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