Active — Not RecruitingPhase 1/2

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

United States40 participantsStarted 2022-08-25

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Women and men ≥ 18 years old are eligible to enroll
✓. ECOG performance status 0-1
✓. Life expectancy of more than 6 months, in the opinion of the investigator
✓. 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.
✓. 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).
✓. Known ER and PR status of the tumor defined by IHC according to the latest ASCO/CAP guidelines
✓. Patients with HR-/HER2+ or HR+/HER2+ breast cancer may enroll
✓. HR+/HER2+ patients should be men or post-menopausal women; premenopausal women with HR+/HER2+ breast cancer are eligible if on ovarian suppression, or agreeable to mandatory ovarian suppression

✕. Patients with contraindications to undergo contrast MRI imaging of the brain are excluded from the study
✕. Pregnancy or breast feeding
✕. 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.
✕. Based on screening brain MRI, patients must not have any of the following:

Phase Ib Safety and Tolerability of alpelisib and tucatinib combination, summary of all AEs and SAEs on study as evaluated by NCI-CTCAE v 5.0

Timeframe: 10 Months

Phase II Efficacy of tucatinib combination evaluated by progression free survival (PFS)

Timeframe: 20 Months

NCT IDNCT05230810

SponsorCriterium, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-30

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Women and men ≥ 18 years old are eligible to enroll
✓. ECOG performance status 0-1
✓. Life expectancy of more than 6 months, in the opinion of the investigator
✓. 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.
✓. 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).
✓. Known ER and PR status of the tumor defined by IHC according to the latest ASCO/CAP guidelines
✓. Patients with HR-/HER2+ or HR+/HER2+ breast cancer may enroll
✓. HR+/HER2+ patients should be men or post-menopausal women; premenopausal women with HR+/HER2+ breast cancer are eligible if on ovarian suppression, or agreeable to mandatory ovarian suppression

✕. Patients with contraindications to undergo contrast MRI imaging of the brain are excluded from the study
✕. Pregnancy or breast feeding
✕. 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.
✕. Based on screening brain MRI, patients must not have any of the following: