Clinical trial · Observational
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
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low recruitment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alpelisib | Other | — | UNRESOLVED |
| Fulvestrant | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- alpelisib in combination with fulvestrant
- description
- Patients treated with alpelisib in combination with fulvestrant
- interventionNames
- Other: Alpelisib
- Other: Fulvestrant
Primary outcomes (1)
- measure
- Incidence proportion of hyperglycemia
- timeFrame
- Up to 53 months
- description
- To assess the incidence of hyperglycemia (Adverse Event of Special Iinterest) observed during follow-up of patients treated with alpelisib in combination with fulvestrant.
Secondary outcomes (10)
- measure
- Calculated BMI
- timeFrame
- Baseline
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available