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

NCT04300790 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2025-07-29

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Alpelisib

Alpelisib (BYL719): starting dose at 300 mg/QD.; 2 tablets once a day, oral administration, continuously during 28-day cycles until disease progression or unacceptable toxicity.

DRUG

Metformin

500 mg BID with breakfast and dinner. After 3 days, if no (GI) intolerance, increase to 1000 mg BID with breakfast and dinner. If not tolerated, reduce to prior tolerated dose. Titrate to 1000mg BID over a period of at least 4 additional days

DRUG

Fulvestrant

fulvestrant (500 mg IM injections; loading dose 500mg every two weeks for the first month; then every 4 weeks as per standard of care \[SoC\]. Patients should be started on metformin and fulvestrant within 7 to 14 days prior to start on alpelisib (D1C1)

DRUG

Letrozole

Letrozole 2.5 mg tablets, once daily, orally

DRUG

Exemestane

Exemestane 25 mg tablets, once daily, orally

DRUG

Vildagliptin

Vildagliptin 50 mg tablets, twice daily, orally with breakfast and dinner

DRUG

Tamoxifen

Tamoxifen 20 mg tablets, once daily, orally

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • MedSIR

    lead OTHER

Principal Investigators

  • Antonio Llombart · MedSIR

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-23
Primary Completion
2022-06-15
Completion
2025-03-16

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04300790 on ClinicalTrials.gov