Last Update: Sep 21, 2023
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
ClinicalTrials.gov Identifier:
Novartis Reference Number:CBYL719C2404
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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. Once the patient provides informed consent, he or she is enrolled in the study. Patients
will 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 occurs
first. The end of the study is defined as a maximum of 12 months after the date the last
patient was enrolled (LPFV); if the last patient is still on treatment on that date, they
will not be followed up any further

Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation
Recruiting
150
Jun 21, 2023
Dec 19, 2025
All
18 Years - (Adult, Older Adult)

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.

Eligibility 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:

- 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

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