New pill shows promise for advanced breast cancer in early trial

NCT ID NCT05596409

Ongoing Disease control Sponsor: Stemline Therapeutics, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 2 trial tests the drug elacestrant in 61 people with estrogen receptor-positive, HER2-negative metastatic breast cancer who have not previously used CDK4/6 inhibitors. Participants take a daily pill for about 6 months. The study aims to see if the drug can delay cancer progression and shrink tumors.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Elacestrant (a hormone therapy pill taken once daily)
What this could lead to: If successful, this could provide a new oral treatment option for people with a common type of advanced breast cancer who haven't tried CDK4/6 inhibitors yet.
What could go wrong: This is a small, early-phase (Phase 2) study with only 61 participants, so results may not apply to everyone. The drug may not improve survival or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

METASTATIC BREAST CANCER

Contacts and locations

Locations

COMPLEX ONCOLOGICAL CENTER - Shumen

Shumen, 9700, Bulgaria
Centro De Pesquisa Clinica DO Hospital Sirio-Libanes - UNIDADE Brasilia

Brasília, 70200-730, Brazil
Centro de Estudos e Pesquisas de Hematologia e Oncologia- CEPHO

Santo André, São Paulo, 09060-650, Brazil
Centro de Pesquisas Clinicas em Oncologia (Center for Clinical Research in Oncology (CPCO)) - Hospital Evangélico de Cachoeiro de Itapemirim

Cachoeiro de Itapemirim, Espírito Santo, 29308-014, Brazil
Centro de Pesquisas Oncologicas

Florianópolis, Santa Catarina, 88034-000, Brazil
Clinica de Pesquisas e Centro de Estudos Em Oncologia Ginecologica e Mamaria Ltda

São Paulo, 01317-001, Brazil
Complex Oncology Center

Plovdiv, 4000, Bulgaria
Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89128, United States
Fucam, Ac.

Mexico City, 4980, Mexico
Highlands Oncology Group, PA

Springdale, Arkansas, 72762, United States
Hospital São Lucas PUCRS - Centro de Pesquisa em Oncologia (CPO)

Porto Alegre, Rio Granda Do Sul, 70200-730, Brazil
Hospital de Amor de Barretos

Barretos, São Paulo, 14784-400, Brazil
Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Granda Do Sul, 90035, Brazil
I CAN Oncology Center, Centro Medico AVE

Monterrey, Nuevo León, 64710, Mexico
Innova Medical Center

Tbilisi, 179, Georgia
Institute of Clinical Oncology

Tbilisi, Georgia
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca

Cluj-Napoca, Cluj, 400150, Romania
LTD Simon Khechinashvili University Clinic

Tbilisi, 179, Georgia
Northwestern University, Northwestern Feinberg School of Medicine Prentice Women's Hospital

Chicago, Illinois, 60611, United States
Torre Medica Hospital Dalinde

Mexico City, 06760, Mexico
UT Health San Antonio Mays Cancer Center

San Antonio, Texas, 78229, United States
Unidad Médica Onco-Hematológica

Puebla City, 4515, Mexico

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