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
Reason given: Low recruitment
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT04967248
- Record updated
- 4 December 2025
- Original description
This was a prospective, multi-national, non-interventional study (NIS) collecting data from postmenopausal women, and adult men, with HR+, HER2- locally advanced or metastatic breast cancer whose tumor harbors a PIK3CA mutation, and who were to be treated with alpelisib in combination with fulvestrant after disease progression following endocrine therapy as monotherapy, in the real-world setting.Read full original descriptionShow less
Alpelisib (Piqray®) Post-Authorization Safety Study (PASS): a Non-interventional Study of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-), Locally Advanced or Metastatic Breast Cancer With a Phosphatidylinositol-3-kinase Catalytic Subunit Alpha (PIK3CA) Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting
This was a prospective, multi-national, non-interventional study (NIS) collecting data from postmenopausal women, and adult men, with HR+, HER2- locally advanced or metastatic breast cancer whose tumor harbors a PIK3CA mutation, and who were to be treated with alpelisib in combination with fulvestrant after disease progression following endocrine therapy as monotherapy, in the real-world setting.
Inclusion: Signed informed consent from the patient or a legally acceptable representative, obtained before any study-related activities are undertaken; Patients diagnosed with HR+, HER2- locally advanced or metastatic breast cancer with a PIK3CA mutation; Patients who have disease progression following endocrine therapy as monotherapy; Patients must be postmenopausal women, or men, ≥18 years of age; Patients recruited on or before their first prescribed dose of alpelisib in combination with fulvestrant.
Exclusion: Use of alpelisib prior to signing the informed consent form for this study; Participation in an interventional study within 30 days prior to the initiation of alpelisib.