Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer (EMERALD)
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|ClinicalTrials.gov Identifier: NCT03778931|
Recruitment Status : Active, not recruiting
First Posted : December 19, 2018
Last Update Posted : July 22, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Elacestrant Drug: Standard of Care||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||466 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Actual Study Start Date :||May 10, 2019|
|Actual Primary Completion Date :||August 24, 2021|
|Estimated Study Completion Date :||August 2024|
Subjects in Arm 1 will receive elacestrant
400 mg/day once daily oral dosing
Other Name: RAD1901
Active Comparator: Standard of Care (SoC)
Subjects in Arm 2 will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane)
Drug: Standard of Care
Other Name: Faslodex, Arimidex, Femara, Aromasin
- Progression Free Survival (PFS) in the ESR1-mut subjects [ Time Frame: From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months) ]Progression Free Survival (PFS) based on blinded IRC assessment in the ESR1-mut subjects
- PFS in all (ESR1-mut and ESR1-WT) subjects [ Time Frame: From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months) ]PFS based on blinded Imaging Review Committee (IRC) assessment in all (ESR1-mut and ESR1-WT) subjects
- Objective Survival (OS) in ESR1-mut subjects [ Time Frame: From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months) ]OS in ESR1-mut subjects, where OS is defined as the length of time from randomization until the date of death from any cause
- OS in all (ESR1-mut and ESR1-WT) subjects [ Time Frame: From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months) ]OS in all (ESR1-mut and ESR1-WT) subjects
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Critical Inclusion Criteria:
- Subjects 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.
- Subjects must be appropriate candidates for endocrine monotherapy
- Subjects must have measurable disease or, nonmeasurable (evaluable) bone-only disease
- Female or male subjects age ≥ 18 years; female subjects must be postmenopausal women and male subjects must not allow pregnancy with their sperm (abstain, do not donate sperm, etc).
- Subjects must have ER+/HER2-tumor status
- Subjects 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.
- Subjects must have received prior treatment with a CDK4/6 inhibitor in combination with either fulvestrant or an aromatase inhibitor (AI).
- Subjects may have received no more than one line of chemotherapy in the advanced/metastatic setting.
- Subjects must have ctDNA ESR1-mut or ESR1-WT status as determined by central testing with Guardant360CDx® before subject is randomized.
Critical 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 < 28 days before first dose of study drug
- Any endocrine therapy < 14 days before first dose of study drug (with the exception of GnRH agonist therapy in male subjects)
- Chemotherapy < 21 days before first dose of study drug
- Any investigational anti-cancer drug therapy < 28 days or five half-lives (whichever is shorter) before the first dose of study drug. Enrollment of subjects whose most recent therapy was an investigational agent should be discussed with the Sponsor
- Presence of symptomatic visceral disease as defined in protocol.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03778931
|Study Director:||Sr. Director, Clinical Operations||Radius Health, Inc.|
|Responsible Party:||Stemline Therapeutics, Inc.|
|Other Study ID Numbers:||
|First Posted:||December 19, 2018 Key Record Dates|
|Last Update Posted:||July 22, 2022|
|Last Verified:||July 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Neoplasms by Site
Antineoplastic Agents, Hormonal
Estrogen Receptor Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Steroid Synthesis Inhibitors
Molecular Mechanisms of Pharmacological Action