Advanced Hormone Receptor Positive (HR+) Breast Cancer Clinical Trial
Official title:
Managed Access Program (MAP) Cohort Treatment Plan CRAD001Y2002M to Provide Access to Afinitor for Patients With Advanced Hormone Receptor Positive (HR+) Breast Cancer
The purpose of this Managed Access Program (MAP) Cohort Treatment Plan is to provide guidance to the Physician for the treatment and monitoring of patients in the Cohort MAP.
Prior to inclusion of a patient in the Cohort, the requesting Physician must submit a request for access to the product in GEMS (Grants, External Requests and Managed Access System) accessible through https://www.novartis.com/our-focus/healthcare-professionals/managedaccess-programs providing the rationale for the request and relevant medical history of the patient. The request is then assessed against the MAP and Cohort inclusion/exclusion criteria by the medical team experienced with the product and indication. Upon the required approvals, the patient is included in the Cohort. ;