BREAST: METASTATIC: ER+, HER2 negative: 2nd Line: EMERALD

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

Title
Radius RAD1901-308 (Breast elacestrant)
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

Site Link
Malignancy
Breast, invasive breast cancer, IBC
Stage
Disease Setting
Metastatic/Palliative
Line Of Therapy
2nd Line (post CDK4/6 inh)
Investigational Agent
Elacestrant
Drug Class
Selective Estrogen Receptor Degrader (SERD)
PI
Greg Vidal, MD, PhD
Sponsor
Radius Pharmaceuticals, Inc.
Phase
Status
Key Eligibility Criteria
Key Eligibility Criteria Details
  • Subjects with adenocarcinoma of the breast with evidence of either locally advanced disease not amenable to resection or XRT, or metastatic disease
  • Must be appropriate candidates for endocrine monotherapy
  • Either measurable disease or bone-only (nonmeasurable) disease
  • Post-menopausal women or men
  • Must be ER+, HER2 -
  • Must have received at least one and no more than two lines of endocrine therapy for advanced/metastatic breast cancer
  • Must have received prior treatment with CDK4/6 inhibitor in combination with either fulvestrant or an AI
  • No more than one line of chemotherapy in the advanced/metastic setting
  • No prior treatment with investigational SERD or ER antagonist
  • No presence of symptomatic visceral disease
Objective
  • Primary-
    • PFS in ESR1 mutant patients
    • PFS in all patients
  • Secondary
    • OS in ESR1 mutant
    • OS in all patients
Assessment Frequency
_
Assessment Frequency 2
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Assessment Frequency Link
Path
adenocarcinoma, ER/PR +, HER2-
Dosing Frequency
Control Agents
Fulvestrant 500mg or anastrazole, letrozole, or exemestane
Study Protocol
Randomized
Yes
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