drugset / Trial / NCT03706573

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

NCT03706573

Expanded access No longer available Novartis Pharmaceuticals

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.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Alpelisib Small molecule 300 mg Oral
Subject Alpelisib Small molecule 350 mg Oral