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NCT05596409 · ClinicalTrials.gov registry record · Phase 2

ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study

A Phase 2 study of Metastatic Breast Cancer, sponsored by Stemline Therapeutics.

Active
Registry status
Phase 2
Development phase
61
Enrollment target
20
Study locations

NCT05596409 is a Phase 2 study of Metastatic Breast Cancer that is active but no longer recruiting, run by Stemline Therapeutics. The registered enrollment target is 61 participants, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (70% lower). The trial reports 20 study locations across 16 states.

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The verdict

NCT05596409, a Phase 2 study of Metastatic Breast Cancer, is active but no longer recruiting, sponsored by Stemline Therapeutics.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
61 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to evaluate the efficacy and safety of elacestrant over the course of 6 months in patients with estrogen receptor positive (ER+)/human epidermal growth factor receptor-2 negative (HER2-) advanced/metastatic breast cancer who received no prior cyclin-dependent kinase targeting enzymes CDK4 and CDK6 inhibitor (CDK4/6i) in the metastatic setting.

Conditions Studied

Metastatic Breast Cancer

Interventions

  • DRUG Elacestrant

Study Locations (20)

Other

  • Centro De Pesquisa Clinica DO Hospital Sirio-Libanes - UNIDADE Brasilia - Brasília
  • Clinica de Pesquisas e Centro de Estudos Em Oncologia Ginecologica e Mamaria Ltda - São Paulo
  • Complex Oncology Center - Plovdiv

Rio Granda Do Sul

  • Hospital São Lucas PUCRS - Centro de Pesquisa em Oncologia (CPO) - Porto Alegre
  • Hospital de Clinicas de Porto Alegre - Porto Alegre

São Paulo

  • Hospital de Amor de Barretos - Barretos
  • Centro de Estudos e Pesquisas de Hematologia e Oncologia- CEPHO - Santo André

Arkansas

  • Highlands Oncology Group, PA - Springdale

California

  • OPN Healthcare - Arcadia

Colorado

  • University of Colorado Cancer Center - Aurora

Florida

  • Morton Plant Hospital - Baycare Health System - Clearwater

Illinois

  • Northwestern University, Northwestern Feinberg School of Medicine Prentice Women's Hospital - Chicago

Trial Details

FieldValue
Enrollment Target 61 participants
Start Date 2023-05-19
Est. Completion 2027-07
Phase Phase 2

Sponsor

Stemline Therapeutics

17 total trials

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What the Registry Record Tells You About NCT05596409

The ClinicalTrials.gov registry entry for NCT05596409 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (70% lower). The listed sponsor is Stemline Therapeutics, which has 17 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Elacestrant is the first listed.

NCT05596409 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Other, Rio Granda Do Sul, São Paulo.

Frequently Asked Questions

What is clinical trial NCT05596409 about?

NCT05596409 is a clinical study titled "ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study". The purpose of this study is to evaluate the efficacy and safety of elacestrant over the course of 6 months in patients with estrogen receptor positive (ER+)/human epidermal growth factor receptor-2 negative (HER2-) advanced/metastatic breast cancer who received no prior cyclin-dependent kinase targ...

What is the current status of trial NCT05596409?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2023-05-19. Estimated completion is 2027-07.

What conditions does trial NCT05596409 study?

This clinical trial studies the following conditions: Metastatic Breast Cancer.

What interventions are being tested in trial NCT05596409?

The interventions under investigation include: Elacestrant (DRUG).

Who is sponsoring clinical trial NCT05596409?

This trial is sponsored by Stemline Therapeutics, which has 17 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05596409 being conducted?

This trial has 20 study locations across Arkansas, California, Colorado, Florida, Illinois. 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.