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Roll-Over Study of Alpelisib (BYL719) for Continued Access and Long-Term Safety.

NCT07679269 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2026-07-01

No results posted yet for this study

Summary

The purpose of this study is to provide post-trial access to alpelisib and to assess its long-term safety when administered as a single agent or in combination with other drugs. This study is intended for participants who are currently receiving alpelisib in a Novartis-sponsored clinical trial (parent study) and, in the Investigator's judgment, would benefit from continued treatment with alpelisib.

Conditions

  • PIK3CA-Related Overgrowth Spectrum (PROS)
  • Breast Neoplasms (Including Advanced or Metastatic Breast Cancer With PIK3CA Mutation)

Interventions

DRUG

Alpelisib

Administered as oral tablets at dose levels as per the parent study, taken once daily.

DRUG

Fulvestrant

Administered as an intramuscular injection at dose levels and dosing schedule as per standard of care, in accordance with the parent study.

DRUG

Trastuzumab

Administered as an intravenous infusion of a reconstituted lyophilized powder at dose levels as per the parent study, given every 21 days.

DRUG

Pertuzumab

Administered as an intravenous infusion of a solution concentrate at dose levels as per the parent study, given every 21 days.

DRUG

Letrozole

Administered as oral tablets at a dose of 2.5 mg, taken once daily, as per the parent study.

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-01
Primary Completion
2031-06-27
Completion
2031-07-25

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07679269 on ClinicalTrials.gov