drugset / Trial / NCT04300790
Study to Evaluate the Effect of Metformin in the Prevention of HG in HR[+]/HER2[-] PIK3CA-mut Advanced BC Patients
RandomizedSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2020-10-23
- Primary completion
- 2022-06-15
- Completion
- 2025-03-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Metformin | Small molecule | 1000 mg | Oral |
| Background | Alpelisib | Small molecule | 300 mg | Oral |
| Background | Exemestane | Small molecule | 25 mg | Oral |
| Background | Fulvestrant | Small molecule | 500 mg | Intramuscular |
| Background | Letrozole | Other / unclassified | 2.5 mg | Oral |
| Background | Tamoxifen | Small molecule | 20 mg | Oral |
| Background | Vildagliptin | Other / unclassified | 50 mg | Oral |