Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

ACTIVE NOT RECRUITING Phase 2

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

NCT05596409 · View on ClinicalTrials.gov ↗

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

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

64 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05596409

The ClinicalTrials.gov registry entry for NCT05596409 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 61 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Stemline Therapeutics, which has 64 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05596409 reports 20 study locations spanning 16 distinct geographic areas — top geographies include Other, Rio Granda Do Sul, São Paulo. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05596409?

The interventions under investigation include: Elacestrant (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05596409?

This trial is sponsored by Stemline Therapeutics, which has 64 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial