NCT04967248View on ClinicalTrials.gov

A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting

TerminatedOBSERVATIONAL
Enrollment

4

Participants

Timeline

Start Date

June 21, 2023

Primary Completion Date

October 18, 2024

Study Completion Date

October 18, 2024

Conditions
Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation
Interventions
OTHER

Alpelisib

Prospective observational PASS study. There is no treatment allocation. Patients recruited on or before their first prescribed dose of alpelisib in combination with fulvestrant will be enrolled.

OTHER

Fulvestrant

Prospective observational PASS study. There is no treatment allocation. Patients recruited on or before their first prescribed dose of alpelisib in combination with fulvestrant will be enrolled.

Trial Locations (3)

27100

Novartis Investigative Site, Pavia

70124

Novartis Investigative Site, Bari

85100

Novartis Investigative Site, Potenza

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY

NCT04967248 - A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting | Biotech Hunter | Biotech Hunter