West Cancer Center

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

Site Link

NCT03778931

Malignancy

Breast, invasive breast cancer, IBC

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

2nd Line (post CDK4/6 inh)

Investigational Agent

Elacestrant

Drug Class

Selective Estrogen Receptor Degrader (SERD)

Greg Vidal, MD, PhD

Sponsor

Radius Pharmaceuticals, Inc.

Phase

Phase 3

Status

Closed to Accrual

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

Assessment Frequency Link

Path

adenocarcinoma, ER/PR +, HER2-

Dosing Frequency

Control Agents

Fulvestrant 500mg or anastrazole, letrozole, or exemestane

Study Protocol

Randomized

Yes