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

Novartis

Status

Terminated

Conditions

Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation

Treatments

Other: Fulvestrant

Other: Alpelisib

Study type

Observational

Funder types

Industry

Identifiers

NCT04967248

CBYL719C2404

Details and patient eligibility

About

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.

Full description

Once the patient provided informed consent, he or she was enrolled in the study. Patients were planned to be followed from enrollment until 1) 30 days after alpelisib treatment discontinuation, or 2) death, or 3) lost to follow-up, or 4) patient withdrawal, or 5) physician decision to end treatment/study, or 6) end of the study, whichever occured first. The end of the study was defined as a maximum of 12 months after the date the last patient was enrolled (LPFV); if the last patient was still on treatment on that date, they were not be followed up any further.

Due to very low patient numbers (4 patients, including 2 eligible patients) no statistical analyses were performed. Database lock was achieved without all queries resolved.

Enrollment

4 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

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