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Managed Access Program to Provide Alpelisib for Patients With HR+ Advanced or Metastatic Breast Cancer

NCT03706573 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2021-07-19

No results posted yet for this study

Summary

The purpose of this Cohort Treatment Plan is to allow access to alpelisib for eligible patients diagnosed with hormone receptor positive, advanced or metastatic breast cancer harboring a phosphatidylinositol 3-kinase (PI3K)CA mutation. The patient's Treating Physician should follow the suggested treatment guidelines and comply with all local health authority regulations.

Conditions

  • HR+ Advanced or Metastatic Breast Cancer

Interventions

DRUG

alpelisib

50 mg and 200 mg film coated tablets administered orally once daily. Starting dose is 350 mg daily. Starting dose as a combination agent with endocrine partner is 300mg daily.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
Healthy Volunteers
No

Timeline & Regulatory

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Entities

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 NCT03706573 on ClinicalTrials.gov