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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
Results First Posted : December 5, 2023
Last Update Posted : March 29, 2024
Sponsor:
Information provided by (Responsible Party):
Stemline Therapeutics, Inc.

Study Description
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Brief Summary:
This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with breast cancer whose disease has advanced on at least one endocrine therapy including a CDK4/6 inhibitor in combination with fulvestrant or an aromatase inhibitor (AI) .

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Elacestrant Drug: Standard of Care Phase 3

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 478 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Elacestrant
Subjects in Arm 1 will receive elacestrant
 Drug: 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
  • Fulvestrant: 500 mg administered intramuscularly (IM) into the buttocks as two 5 mL injections on C1D1, C1D15 and C2D1 and Day 1 of every subsequent 28-day cycle
  • Anastrozole 1 mg/day on a continuous dosing schedule
  • Letrozole: 2.5 mg/day on a continuous dosing schedule
  • Exemestane: 25 mg/day on a continuous dosing schedule
Other Name: Faslodex, Arimidex, Femara, Aromasin


Outcome Measures
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Primary Outcome Measures :
  1. Progression-free Survival in 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 based on blinded IRC assessment in ESR1-mut subjects defined as the length of time from randomization until the date of objective disease progression per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) as assessed by the blinded IRC or death from any cause. Progression is defined per RECIST v1.1 as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

  2. Progression-free Survival in All Subjects [ Time Frame: From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months) ]
    Progression-free Survival based on blinded Imaging Review Committee (IRC) assessment in all (ESR1-mut and ESR1-WT) subjects


Secondary Outcome Measures :
  1. Overall Survival in ESR1-mut Subjects [ Time Frame: From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months) ]
    Overall Survival in ESR1-mut subjects, where Overall Survival is defined as the length of time from randomization until the date of death from any cause

  2. Overall Survival in All Subjects [ Time Frame: From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months) ]
    Overall Survival in All (ESR1-mut and ESR1-WT) Subjects


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Critical Inclusion Criteria:

  1. 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.
  2. Subjects must be appropriate candidates for endocrine monotherapy
  3. Subjects must have measurable disease or nonmeasurable (evaluable) bone-only disease
  4. 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).
  5. Subjects must have ER+/HER2- tumor status
  6. 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.
  7. Subjects must have received prior treatment with a CDK4/6 inhibitor in combination with either fulvestrant or an aromatase inhibitor (AI).
  8. Subjects may have received no more than one line of chemotherapy in the advanced/metastatic setting.
  9. Subjects must have ctDNA ESR1-mut or ESR1-WT status as determined by central testing with Guardant360CDx® before subject is randomized.

Critical Exclusion Criteria:

  1. Prior treatment with elacestrant, GDC-0810, GDC-0927, GDC-9545, LSZ102, AZD9496, bazedoxifene, or other investigational SERD or investigational ER antagonist.

  2. Prior anticancer or investigational drug treatment within the following windows:

    1. Fulvestrant treatment < 28 days before first dose of study drug
    2. Any endocrine therapy < 14 days before first dose of study drug (with the exception of GnRH agonist therapy in male subjects)
    3. Chemotherapy < 21 days before first dose of study drug
    4. 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
  3. Presence of symptomatic visceral disease as defined in protocol.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Stemline Therapeutics, Inc.
  Study Documents (Full-Text)

Documents provided by Stemline Therapeutics, Inc.:
Study Protocol  [PDF] March 25, 2020
Statistical Analysis Plan  [PDF] May 10, 2021

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Stemline Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03778931    
Other Study ID Numbers: RAD1901-308
First Posted: December 19, 2018    Key Record Dates
Results First Posted: December 5, 2023
Last Update Posted: March 29, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Anastrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
 Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action