Official Title
Managed Access Program (MAP) to Provide Access to Alpelisib for Patients With HR-positive, HER2-negative Advanced Breast Cancer With Mutated Phosphoinositide 3-kinase Who Progressed on or After AI Treatment
Brief Summary

The purpose of this Cohort Treatment Plan is to allow access to alpelisib for patients diagnosed with HR-positive, HER2-negative advanced breast cancer with mutated phosphoinositide 3-kinase who progressed on or after AI treatment. The patient's Treating Physician should follow the suggested treatment guidelines and comply with all local health authority regulations.

Intermediate-size Population
HR+, HER2-, Advanced Breast Cancer

Drug: alpelisib
Alpelisib is provided as 50 mg and 200 mg film coated tablets as individual patient supply, packaged in bottles. Alpelisib will be dosed on a flat scale of mg/day and not be adjusted to body weight or body surface area. Alpelisib will be administered at a starting dose of 300 mg orally once daily on a continuous dosing schedule and can be adjusted for toxicity per the recommendations in this treatment plan.

Eligibility Criteria

Inclusion Criteria:

Patients eligible for inclusion in this Treatment Plan have to meet all of the following

Written patient informed consent must be obtained prior to start of treatment. 1. Patient is an adult male or female (≥ 18 years of age) with advanced (locoregionally recurrent not amenable to curative therapy or metastatic) hormone receptor-positive, HER2-negative breast cancer 2. Patient has documented evidence of a mutation in the PIK3CA gene as determined in tumor tissue or plasma by a local laboratory. 3. If female, then the patient is postmenopausal. Postmenopausal status is defined either by: - Prior bilateral oophorectomy - Age ≥60 - Age

Eligibility Gender
Eligibility Age
Minimum: 18 Years~Maximum: 99 Years

Novartis Pharmaceuticals

Novartis Pharmaceuticals

Novartis Pharmaceuticals
NCT Number
hormone receptor positive
breast cancer
PIK3CA gene
Expanded Access
advanced breast cancer
stage IV
MeSH Terms
Breast Neoplasms
Intervention Name