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Trial record 1 of 4 for:    elacestrant
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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 : Recruiting
First Posted : December 19, 2018
Last Update Posted : May 4, 2020
Sponsor:
Information provided by (Responsible Party):
Radius Pharmaceuticals, Inc.

Tracking Information
First Submitted Date  ICMJE December 3, 2018
First Posted Date  ICMJE December 19, 2018
Last Update Posted Date May 4, 2020
Actual Study Start Date  ICMJE November 20, 2018
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 14, 2018)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2018)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer
Official Title  ICMJE 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
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) .
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Elacestrant
    400 mg/day once daily oral dosing
    Other Name: RAD1901
  • 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
Study Arms  ICMJE
  • Experimental: Elacestrant
    Subjects in Arm 1 will receive elacestrant
    Intervention: Drug: Elacestrant
  • 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)
    Intervention: Drug: Standard of Care
Publications * Bardia A, Aftimos P, Bihani T, Anderson-Villaluz AT, Jung J, Conlan MG, Kaklamani VG. EMERALD: Phase III trial of elacestrant (RAD1901) vs endocrine therapy for previously treated ER+ advanced breast cancer. Future Oncol. 2019 Oct;15(28):3209-3218. doi: 10.2217/fon-2019-0370. Epub 2019 Aug 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 14, 2018)
466
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2022
Estimated Primary Completion Date August 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Director, Clinical Operations 1-855-672-3487 clinopsinfo@radiuspharm.com
Contact: Clinical Operations, Radius clinopsinfo@radiuspharm.com
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Canada,   Denmark,   France,   Greece,   Hungary,   Ireland,   Israel,   Italy,   Korea, Republic of,   Portugal,   Spain,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03778931
Other Study ID Numbers  ICMJE RAD1901-308
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Radius Pharmaceuticals, Inc.
Study Sponsor  ICMJE Radius Pharmaceuticals, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sr. Director, Clinical Operations Radius Health, Inc.
PRS Account Radius Pharmaceuticals, Inc.
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP