OncoMatch/Clinical Trials/NCT07766018
A Phase 2 Bridging Study of Elacestrant Monotherapy in Advanced or Metastatic Breast Cancer
Is NCT07766018 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies Elacestrant for er+/her2- advanced or metastatic breast cancer.
Treatment: Elacestrant — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Endocrine / hormonal
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 mutation
Participants must be ESR1-mutant positive determined via testing with the Guardant360 Companion Diagnostic panel test prior to enrollment
Required: ESR1 expression (positive)
Must have ER+ and HER2- tumor status confirmed per local laboratory testing
Required: HER2 (ERBB2) wild-type (negative)
Must have ER+ and HER2- tumor status confirmed per local laboratory testing
Prior therapy
Must have received: CDK4/6 inhibitor — in combination with either fulvestrant or an aromatase inhibitor for metastatic breast cancer
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
Cannot have received: selective estrogen receptor degrader (elacestrant)
Prior treatment with: elacestrant or investigational or approved selective estrogen receptor degrader or ER antagonist
Cannot have received: ER antagonist
Prior treatment with: elacestrant or investigational or approved selective estrogen receptor degrader or ER antagonist
Cannot have received: antibody-drug conjugate
Exception: for advanced/metastatic breast cancer
Prior treatment with: antibody-drug conjugate therapy for advanced/metastatic breast cancer
Cannot have received: anti-cancer or investigational drug treatment
Prior treatment with: anti-cancer or investigational drug treatment
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07766018 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior selective estrogen receptor degrader, ER antagonist, antibody-drug conjugate disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 mutation is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages