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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 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.

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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.

Conditions Studied

HER2-Negative Breast Cancer Hormone Receptor-Positive Breast Carcinoma PIK3CA Mutant Metastatic Breast Cancer

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

FieldValue
Enrollment Target 44 participants
Start Date 2021-02-12
Est. Completion 2026-05
Phase Phase 2

Sponsor

Marina N Sharifi

1 total trials

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What the Registry Record Tells You About NCT04762979

The ClinicalTrials.gov registry entry for NCT04762979 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 254-participant average among 49 other HER2-Negative Breast Cancer trials with a reported enrollment target (83% lower). The listed sponsor is Marina N Sharifi, which has 1 total studies on file at ClinicalTrials.gov.

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 4 study locations spanning 4 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.