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Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer. | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer.

This is a Multicenter, Single Arm, Open-label, run-in Phase Ib / Roll-over Phase II Study of Tucatinib in Combination With Alpelisib in Subjects With PIK3CA-mutant HER2-positive Locally Advanced Unresectable or Metastatic Breast Cancer.

NCT05230810•Criterium, Inc.

View on ClinicalTrials.gov

Summary

Phase IB/II clinical trial of Alpelisb and Tucatinib in patients with PIK3CA-Mutant HER2-positive metastatic breast cancer.

Detailed Description

This study is a multicenter, single arm, open-label, run-in phase Ib safety cohort with immediate roll over to a phase II clinical trial that will test the combination therapy of tucatinib with alpelisib in subjects with PIK3CA-mutant HER2+ locally advanced unresectable or metastatic breast cancer. Patients with PIK3CA-mutant HR-/HER2+ and HR+/HER2+ breast cancer may enroll, the latter cohort will receive concomitant treatment with standard doses of fulvestrant to block HR signaling. In phase Ib part, we will confirm the tolerability of tucatinib and alpelisib combination and determine the maximum tolerated dose (MTD). In phase II part, we will expand the testing of this drug combination at MTD to determine the PFS rate.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Criteria:
•1. Women and men ≥ 18 years old are eligible to enroll
•2. ECOG performance status 0-1
•3. Life expectancy of more than 6 months, in the opinion of the investigator
•4. Histologically confirmed diagnosis of HER2+ locally advanced unresectable or metastatic breast cancer. HER2 positivity is defined by fluorescence in situ hybridization (FISH) and/or 3+ staining by IHC according to the latest ASCO/CAP guidelines.
•5. Documented presence of activating mutation in PIK3CA in the tumor, based on the analysis of solid or liquid biopsy by an assay approved for clinical decision makingby an FDA-approved test (examples include FoundationOne Liquid®; Guardant360®, Therrascreen® PIK3CA).
•6. Known ER and PR status of the tumor defined by IHC according to the latest ASCO/CAP guidelines
•7. Patients with HR-/HER2+ or HR+/HER2+ breast cancer may enroll
•9. HR+/HER2+ patients should be agreeable to concomitant treatment with fulvestrant per study protocol. Prior therapy with fulvestrant is allowed.
•10. Patients should have received at least two FDA-approved HER2-targeted agents at any time in the course of their disease. Note: 1 line of therapy containing EGFR or HER2-tyrosine kinase inhibitors (for example, neratinib, tucatinib, lapatinib, afatinib, pyrotinib, etc.) in the metastatic setting is allowed
+20 more criteria

Exclusion Criteria

•1. Patients with contraindications to undergo contrast MRI imaging of the brain are excluded from the study
•2. Pregnancy or breast feeding
•3. Any systemic anti-cancer therapy (including hormonal therapy or investigational agents) or surgery in \<14 days prior to the first dose of study treatment WBRT in \<21 days, SBRT for CNS disease in \<7 days, or palliative radiation to extracranial sites in \<14 days prior to the first dose of study treatment5.
•4. Based on screening brain MRI, patients must not have any of the following:

Locations (4)

University of Colorado Cancer Center

Aurora, Colorado, United States

Cancer Care & Hematology-Fort Collins

Fort Collins, Colorado, United States

Louisiana State University Health Sciences Center

New Orleans, Louisiana, United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Key Dates

Start Date

August 25, 2022

Primary Completion Date

March 30, 2026

Completion Date

June 30, 2026

Last Updated

March 16, 2026

Enrollment

ESTIMATED participants

Conditions

HER2-positive Metastatic Breast Cancer

Interventions

Alpelisib

DRUG

Tucatinib

DRUG

Fulvestrant

DRUG

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

NCT06625775

Solid Tumor, AdultMetastatic Breast Cancer+9 more

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RECRUITING

QuantifyHER: Quantitative Immunofluorescence and/or RT-qPCR for Measuring HER2 in HER2-low Metastatic Breast Cancer

NCT06551116

HER2-positive Metastatic Breast Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer.

Inclusion Criteria

Exclusion Criteria

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