Study to Evaluate the Effect of Metformin in the Prevention of HG in HR[+]/HER2[-] PIK3CA-mut Advanced BC Patients (METALLICA)

  • STATUS
    Not Recruiting
  • End date
    Jul 31, 2024
  • participants needed
    68
  • sponsor
    MedSIR
Updated on 14 September 2022
HER2
PIK3CA
fulvestrant
erbb2
aromatase inhibitor

Summary

Men and post- or induced menopausal women with ER[+] and/or PgR[+], HER2[- ] advanced BC, with centrally-confirmed PI3KCAMut who progressed to an aromatase inhibitor (AI) regimen.

Description

Men and post- or induced menopausal women with ER[+] and/or PgR[+], HER2[- ] advanced BC, with centrally-confirmed PI3KCAMut who progressed to an aromatase inhibitor (AI) regimen.Men and post- or induced menopausal women with ER[+] and/or PgR[+], HER2[- ] advanced BC, with centrally-confirmed PI3KCAMut who progressed to an aromatase inhibitor (AI) regimen.Measurable or evaluable disease according to RECIST v.1.1 criteria.No prior treatment with fulvestrant or PI3K, AKT or mTOR inhibitors.

No more than one prior line of chemotherapy for metastatic breast cancer (MBC). Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 1. No ongoing antidiabetic treatment.

Details
Condition Breast Cancer
Treatment Metformin, fulvestrant, Alpelisib
Clinical Study IdentifierNCT04300790
SponsorMedSIR
Last Modified on14 September 2022

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