For Healthcare Professionals

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

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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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Signed informed consent from the patient or a legally acceptable representative, obtained before any study-related activities are undertaken
  2. Patients diagnosed with HR+, HER2
  3. locally advanced or metastatic breast cancer with a PIK3CA mutation
  4. Patients who have disease progression following endocrine therapy as monotherapy
  5. Patients must be postmenopausal women, or men, ≥18 years of age
  6. Patients recruited on or before their first prescribed dose of alpelisib in combination with fulvestrant

EXCLUSION CRITERIA

  1. Use of alpelisib prior to signing the informed consent form for this study
  2. Participation in an interventional study within 30 days prior to the initiation of alpelisib
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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.
Phone iconCall +41613241111Email iconEmail Study Center

Study’s details


Contition

Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation

Age

18+

Participants needed

150

Est. Completion Date

Dec 2025

Treatment type

Observational


Sponsor

Novartis

ClinicalTrials.gov identifier

NCT04967248

Study number

CBYL719C2404

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