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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 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.

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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.

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

FieldValue
Enrollment Target 40 participants
Start Date 2022-08-25
Est. Completion 2026-06-30
Phase Phase 1

Sponsor

Criterium

11 total trials

What the Registry Record Tells You About NCT05230810

The ClinicalTrials.gov registry entry for NCT05230810 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 121-participant average among 11 other HER2-positive Metastatic Breast Cancer trials with a reported enrollment target (67% lower). The listed sponsor is Criterium, which has 11 total studies on file at ClinicalTrials.gov.

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 4 study locations spanning 3 distinct geographic areas - top geographies include 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.

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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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.