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NCT04762979 · ClinicalTrials.gov registry record · Phase 2
Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer
A Phase 2 study of HER2-Negative Breast Cancer and Hormone Receptor-Positive Breast Carcinoma, sponsored by Marina N Sharifi.
- Active
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
- 4
- Study locations
NCT04762979: Active Phase 2 study of HER2-Negative Breast Cancer and Hormone Receptor-Positive Breast Carcinoma, sponsored by Marina N Sharifi.
NCT04762979 is a Phase 2 study of HER2-Negative Breast Cancer and Hormone Receptor-Positive Breast Carcinoma that is active but no longer recruiting, run by Marina N Sharifi. The registered enrollment target is 44 participants, below the 254-participant average among 49 other HER2-Negative Breast Cancer trials with a reported enrollment target (83% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04762979, a Phase 2 study of HER2-Negative Breast Cancer and Hormone Receptor-Positive Breast Carcinoma, is active but no longer recruiting, sponsored by Marina N Sharifi.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
- 4
- Study locations
Study Summary
Patients who have histologically confirmed metastatic or unresectable (not amenable to curative therapy) breast cancer may be screened for eligibility. All patients must have HER2 negative breast cancer with the identified PIK3CA mutation and received at least one line of endocrine therapy. The study will consist of a screening phase, a treatment phase, and a post-treatment phase which includes safety, efficacy, and follow-up. The treatment phase will include taking alpelisib daily in combination with continued use of either Fulvestrant or Aromatase Inhibitor per standard of care until disease progression or unacceptable toxicity.
Primary Outcome
To estimate the progression-free survival (PFS) of alpelisib with continued endocrine therapy (aromatase inhibitor or fulvestrant) following progression in patients with hormone receptor positive, HER2 negative, PIK3CA mutant metastatic breast cancer. PFS defined as time from D1 of treatment with alpelisib with endocrine therapy.
Conditions Studied
Interventions
- DRUG Fulvestrant
- DRUG Alpelisib
- DRUG Aromatase inhibitor
Study Locations (4)
Illinois
- University of Illinois Cancer Center - Chicago
Nebraska
- University of Nebraska Medical Center - Omaha
Pennsylvania
- Penn State Cancer Institute - Hershey
Wisconsin
- University of Wisconsin - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2021-02-12 |
| Est. Completion | 2026-05 |
| Phase | Phase 2 |
What the registry record for NCT04762979 still lists
NCT04762979 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 254-participant average among 49 other HER2-Negative Breast Cancer trials with a reported enrollment target (83% lower).
The record links to 3 conditions, with HER2-Negative Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Fulvestrant is the first listed.
NCT04762979 reports a single indexed study location in Illinois, Nebraska, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04762979 about?
NCT04762979 is a clinical study titled "Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer". Patients who have histologically confirmed metastatic or unresectable (not amenable to curative therapy) breast cancer may be screened for eligibility. All patients must have HER2 negative breast cancer with the identified PIK3CA mutation and received at least one line of endocrine therapy. The stud...
What is the current status of trial NCT04762979?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2021-02-12. Estimated completion is 2026-05.
What conditions does trial NCT04762979 study?
This clinical trial studies the following conditions: HER2-Negative Breast Cancer, Hormone Receptor-Positive Breast Carcinoma, PIK3CA Mutant Metastatic Breast Cancer.
What interventions are being tested in trial NCT04762979?
The interventions under investigation include: Fulvestrant (DRUG), Alpelisib (DRUG), Aromatase inhibitor (DRUG).
Who is sponsoring clinical trial NCT04762979?
This trial is sponsored by Marina N Sharifi, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04762979 being conducted?
This trial has 4 study locations across Illinois, Nebraska, Pennsylvania, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04762979's enrollment target sits among peer trials
44 30th of 49 higher than 20 of 49 other HER2-Negative Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HER2-Negative Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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