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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: Active Phase 2 study of Metastatic Breast Cancer, sponsored by Stemline Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS is defined as time from the date of the first dose to the date of the first radiological documentation of disease progression or death, whichever comes first.
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
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2023-05-19 |
| Est. Completion | 2027-07 |
| Phase | Phase 2 |
What the registry record for NCT05596409 still lists
NCT05596409 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (70% lower).
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 names 20 study sites across 16 states, led by 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.
Learn More About Clinical Trials
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Where NCT05596409's enrollment target sits among peer trials
61 77th of 139 higher than 62 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic 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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