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.

Available
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
criteria:

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
All
Eligibility Age
Minimum: 18 Years~Maximum: 99 Years
Contacts

Novartis Pharmaceuticals
+41613241111
novartis.email@novartis.com

Novartis Pharmaceuticals

Novartis Pharmaceuticals
NCT Number
Keywords
byl719
hormone receptor positive
HER2-negative
breast cancer
PIK3CA gene
alpelisib
Expanded Access
advanced breast cancer
stage IV
MeSH Terms
Breast Neoplasms
Intervention Name
alpelisib