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Clinical Trial 20246

Cancer Type: Breast
Study Type: Treatment
NCT#: NCT03778931

Phase: Phase III
Prinicipal Investigator:

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Overview

Study Title

Elacestrant Monotherapy VS. Standard of Care for the Treatment of Patients with ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-Label, Active-Controlled, Multicenter Trial (EMERALD)

Summary

This is an international, multicenter, randomized, open-label, active-controlled, event-driven, Phase 3 clinical study comparing the efficacy and safety of elacestrant to the SoC options of fulvestrant or an aromatase inhibitor (AI) in postmenopausal women and in men with advanced or metastatic ER+/HER2- breast cancer, either in subjects with tumors that harbor mutations in the ligand binding domain (LBD) of the estrogen receptor 1 (ESR1) gene (ESR1-mut subjects) or in all subjects regardless of ESR1 status (ESR1-mut and ESR1 wild type [ESR1-WT]) and whose disease has relapsed or progressed on at least one and no more than two prior lines of endocrine therapy (with documented progression), which must have included prior CDK4/6 inhibitor therapy in combination with fulvestrant or an aromatase inhibitor (AI) and for whom hormonal monotherapy with one of the SoC drugs (fulvestrant, anastrozole, letrozole, exemestane) is an appropriate treatment option.

Objective

Primary and Key Secondary Objectives Primary: To demonstrate that elacestrant compared with the SOC options of either fulvestrant or an AI is superior in prolonging PFS based on a blinded Imaging Review Committee (IRC) assessment in post-menopausal women and men with ER+/HER2- mBC, either in subjects with ESR1 mutations (ESR1-mut subjects) or in all subjects which includes subjects without detectable ESR1 mutations (ESR1-mut-nd) Key Secondary: To compare overall survival (OS) between treatment groups in ESR1-mut subjects. To compare OS between treatment groups in all subjects (ESR1-mut and ESR1-mut-nd)

Treatments

Therapies

Medications

Anastrozole (); Arimadex (Anastrozole); Aromasin (Exemestane); Elacestrant (); Exemestane (); Faslodex (fulvestrant); Femara (Letrozole); Letrozole (); fulvestrant ()

Inclusion Criteria

  • Participants with 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.
  • Participants must be appropriate candidates for endocrine monotherapy
  • Participants must have measurable disease or, nonmeasurable (evaluable) bone-only disease
  • Female or male Participants age ≥ 18 years; female Participants must be postmenopausal women and male Participants must not allow pregnancy with their sperm (abstain, do not donate sperm, etc).
  • Participants must have ER+/HER2-tumor status
  • Participants must have previously received at least one and no more than two lines of endocrine therapy for advanced/metastatic breast cancer and meet additional previous treatment criteria.
  • Participants must have received prior treatment with a CDK4/6 inhibitor in combination with either fulvestrant or an aromatase inhibitor (AI).
  • Participants may have received no more than one line of chemotherapy in the advanced/metastatic setting.
  • Participants must have ctDNA ESR1-mut or ESR1-WT status as determined by central testing before subject is randomized.

  • Exclusion Criteria

  • Prior treatment with elacestrant, GDC-0810, GDC-0927, GDC-9545, LSZ102, AZD9496, bazedoxifene, or other investigational SERD or investigational ER antagonist.
  • Prior anticancer or investigational drug treatment within the following windows:
  • Fulvestrant treatment >Any endocrine therapy >Chemotherapy >Any investigational anti-cancer drug therapy >Presence of symptomatic visceral disease as defined in protocol.

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