RECRUITING Phase 2 ClinicalTrials.gov

A Phase 2 Bridging Study of Elacestrant Monotherapy in Advanced or Metastatic Breast Cancer

Sponsor: Stemline Therapeutics, Inc. • ClinicalTrials.gov ID: NCT07766018

Registry updated: 2026-10-13

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

This is a multicenter, open-label, Phase 2 bridging study to evaluate the efficacy and safety of elacestrant in Japanese post-menopausal women and men with estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer with estrogen receptor 1 gene mutation (ESR1-mut) whose disease has relapsed or progressed on at least 1 and no more than 2 prior lines of endocrine therapy for metastatic breast cancer, which must have included cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) therapy in combination with fulvestrant or an aromatase inhibitor.

Interventions

Elacestrant (Drug)
Administered as an oral tablet

Eligibility criteria

Key Inclusion Criteria: * Must have a histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either locally advanced disease not amenable to resection or radiation therapy with curative intent or metastatic disease not amenable to curative therapy * Female participants must be post-menopausal (as defined by the protocol) * Must have ER+ and HER2- tumor status confirmed per local laboratory testing * Participants must be ESR1-mutant positive determined via testing with the Guardant360 Companion Diagnostic panel test prior to enrollment * Must have disease progression during or within 28 days of completion of prior treatment with a CDK4/6 inhibitor in combination with either fulvestrant or an aromatase inhibitor (this counts as a line of prior endocrine therapy) for metastatic breast cancer Key Exclusion Criteria: * Prior treatment with: elacestrant or investigational or approved selective estrogen receptor degrader or ER antagonist; antibody-drug conjugate therapy for advanced/metastatic breast cancer; anti-cancer or investigational drug treatment * Radiation therapy within 14 days (28 days for brain lesions) before the first dose of study drug * Intact uterus with a history of endometrial intraepithelial neoplasia (atypical endometrial hyperplasia or higher-grade lesion) * Diagnosis of any other malignancy within 5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or second primary breast cancer Note: Other protocol-defined inclusion/exclusion criteria may apply.

Conditions

Breast Cancer

Locations

Chiba Cancer Center — Chiba, Japan
Kyushu University Hospital — Fukuoka, Japan
National Hospital Organization - Kyushu Medical Center — Fukuoka, Japan
Saitama Cancer Center — Ina, Japan
Tokai University Hospital — Isehara, Japan
The Cancer Institute Hospital of JFCR (Japanese Foundation For Cancer Research) — Kōtō City, Japan
Kumamoto Shinto General Hospital — Kumamoto, Japan
Kumamoto University Hospital — Kumamoto, Japan
Nagoya City University Hospital — Nagoya, Japan
National Hospital Organization - Nagoya Medical Center — Nagoya, Japan
National Hospital Organization - Osaka National Hospital — Osaka, Japan
Kindai University Hospital — Sakaishi, Japan
Hokkaido University Hospital — Sapporo, Japan
National Hospital Organization - Hokkaido Cancer Center — Sapporo, Japan
Shizuoka General Hospital — Shizuoka, Japan
Osaka University Hospital — Suita, Japan
Juntendo University Hospital — Tokyo, Japan
Tokyo Medical University Hospital — Tokyo, Japan
Mie University Hospital — Tsu, Japan

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment