NCT07766018 A Phase 2 Bridging Study of Elacestrant Monotherapy in Advanced or Metastatic Breast Cancer
| NCT ID | NCT07766018 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Stemline Therapeutics, Inc. |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2026-08-18 |
| Primary Completion | 2028-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 70 participants in total. It began in 2026-08-18 with a primary completion date of 2028-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Medical Director
STUDY DIRECTOR
Stemline Therapeutics, Inc.
Frequently Asked Questions
Who can join the NCT07766018 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07766018 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07766018 currently recruiting?
Yes, NCT07766018 is actively recruiting participants. Contact the research team at clinicaltrials@menarinistemline.com for enrollment information.
Where is the NCT07766018 trial being conducted?
This trial is being conducted at Chiba, Japan, Fukuoka, Japan, Fukuoka, Japan, Hirakata, Japan and 11 additional locations.
Who is sponsoring the NCT07766018 clinical trial?
NCT07766018 is sponsored by Stemline Therapeutics, Inc.. The principal investigator is Medical Director at Stemline Therapeutics, Inc.. The trial plans to enroll 70 participants.
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