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
About the study
This is 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 are treated with alpelisib in combination with fulvestrant after disease progression following endocrine therapy as monotherapy, in the real-world setting.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- 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 CRITERIA
Exclusion Criteria:
- 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
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation
Age (in years)
18+
Participants needed
150
Est. Completion Date
Dec 19, 2025
Treatment type
Observational
Sponsor
Novartis
ClinicalTrials.gov identifier
NCT04967248
Study number
CBYL719C2404
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