Ignite Creation Date:
2024-05-06 @ 9:43 AM
Last Modification Date:
2024-10-26 @ 12:18 PM
Study NCT ID:
NCT03056755
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2017-02-15
Brief Title:
Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole Based on Prior Endocrine Therapy in Patients With PIK3CA Mutant HR HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
BYLieve A Phase II Multicenter Open-label Three-cohort Non- Comparative Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole in Patients With PIK3CA Mutant Hormone Receptor HR Positive HER2-negative Advanced Breast Cancer aBC Who Have Progressed on or After Prior Treatments
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BYLieve
Brief Summary:
Study assessing the efficacy and safety of alpelisib plus fulvestrant or letrozole based on prior endocrine therapy in patients with hormone receptor HR positive HER2-negative advanced breast cancer aBC harboring PIK3CA mutations who have progressed on or after prior treatments
Detailed Description:
This is a phase II multicenter open-label three-cohort non-comparative study of alpelisib plus endocrine therapy either fulvestrant or letrozole in patients with HR HER2- aBC harboring PIK3CA mutations in the tumor whose disease has progressed on or after prior treatments
The study includes two phases
Core Phase includes treatment phase for all patients from First Patient First Treatment FPFT until 18 months post Last Patient First Treatment LPFT 1 month Safety follow-up total 19 months post LPFT
Extension Phase includes treatment phase starting at the end of the treatment Core Phase up to 36 months The extension treatment phase is only for patients who are continuing to benefit from treatment at the end of the Core Phase and are not eligible for PSDS Post-Study Drug Supply in their country based on local regulations Patients will continue on their existing treatment assigned in the Core Phase If PSDS becomes available for a patient the patient should be discontinued from the study and access treatment via PSDS During the Extension Phase there will be no per protocol efficacy assessments other than physicians determination as per standard of care of whether or not the patient is continuing to derive clinical benefit from the study treatment
Patients who are benefiting from treatment and are eligible for PSDS will exit the trial at the end of the Core Phase
After discontinuation of study treatment all patients will be followed for safety for at least 30 days except in case of death loss to follow-up or withdrawal of consent
During the Core Phase only If a patient discontinues study treatment for reasons other than documented disease progression death lost to follow-up or withdrawal of consent for efficacy follow-up tumor assessments should continue to be performed until documented disease progression death lost to follow-up or withdrawn consent to efficacy follow-up or end of study Post-treatment efficacy follow-up Moreover all participants will be followed for survival status after progression regardless of treatment discontinuation reason except if consent is withdrawn death or patient is lost to follow-up until death lost to follow-up or withdrawal of consent for survival follow-up or end of the Core Phase
The study includes two phases
Core Phase includes treatment phase for all patients from First Patient First Treatment FPFT until 18 months post Last Patient First Treatment LPFT 1 month Safety follow-up total 19 months post LPFT
Extension Phase includes treatment phase starting at the end of the treatment Core Phase up to 36 months The extension treatment phase is only for patients who are continuing to benefit from treatment at the end of the Core Phase and are not eligible for PSDS Post-Study Drug Supply in their country based on local regulations Patients will continue on their existing treatment assigned in the Core Phase If PSDS becomes available for a patient the patient should be discontinued from the study and access treatment via PSDS During the Extension Phase there will be no per protocol efficacy assessments other than physicians determination as per standard of care of whether or not the patient is continuing to derive clinical benefit from the study treatment
Patients who are benefiting from treatment and are eligible for PSDS will exit the trial at the end of the Core Phase
After discontinuation of study treatment all patients will be followed for safety for at least 30 days except in case of death loss to follow-up or withdrawal of consent
During the Core Phase only If a patient discontinues study treatment for reasons other than documented disease progression death lost to follow-up or withdrawal of consent for efficacy follow-up tumor assessments should continue to be performed until documented disease progression death lost to follow-up or withdrawn consent to efficacy follow-up or end of study Post-treatment efficacy follow-up Moreover all participants will be followed for survival status after progression regardless of treatment discontinuation reason except if consent is withdrawn death or patient is lost to follow-up until death lost to follow-up or withdrawal of consent for survival follow-up or end of the Core Phase
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-004586-67 | EUDRACT_NUMBER | None | None |