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A NIS of Alpelisib in Combina...

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

Last Updated: 2025-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

4 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-21

Study Completion Date

2024-10-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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alpelisib in combination with fulvestrant

Patients treated with alpelisib in combination with fulvestrant

Alpelisib

Intervention Type OTHER

Prospective observational PASS study. There was no treatment allocation. Patients recruited on or before their first prescribed dose of alpelisib in combination with fulvestrant were enrolled.

Fulvestrant

Intervention Type OTHER

Prospective observational PASS study. There was no treatment allocation. Patients recruited on or before their first prescribed dose of alpelisib in combination with fulvestrant were enrolled.

Interventions

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Alpelisib

Prospective observational PASS study. There was no treatment allocation. Patients recruited on or before their first prescribed dose of alpelisib in combination with fulvestrant were enrolled.

Intervention Type OTHER

Fulvestrant

Prospective observational PASS study. There was no treatment allocation. Patients recruited on or before their first prescribed dose of alpelisib in combination with fulvestrant were enrolled.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers