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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03778931
Registration number
NCT03778931
Ethics application status
Date submitted
3/12/2018
Date registered
19/12/2018
Titles & IDs
Public title
Phase 3 Trial of Elacestrant vs. Standard of Care for the Treatment of Patients With ER+/HER2- Advanced Breast Cancer
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Scientific 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
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Secondary ID [1]
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RAD1901-308
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Universal Trial Number (UTN)
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Trial acronym
EMERALD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Elacestrant
Treatment: Drugs - Standard of Care
Experimental: Elacestrant - Subjects in Arm 1 will receive 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)
Treatment: Drugs: Elacestrant
400 mg/day once daily oral dosing
Treatment: Drugs: 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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival in ESR1-mut Subjects
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Assessment method [1]
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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.
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Timepoint [1]
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From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months)
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Primary outcome [2]
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Progression-free Survival in All Subjects
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Assessment method [2]
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Progression-free Survival based on blinded Imaging Review Committee (IRC) assessment in all (ESR1-mut and ESR1-WT) subjects
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Timepoint [2]
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From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months)
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Secondary outcome [1]
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Overall Survival in ESR1-mut Subjects
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Assessment method [1]
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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
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Timepoint [1]
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From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months)
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Secondary outcome [2]
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Overall Survival in All Subjects
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Assessment method [2]
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Overall Survival in All (ESR1-mut and ESR1-WT) Subjects
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Timepoint [2]
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From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months)
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Eligibility
Key inclusion criteria
Critical
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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/05/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/08/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
478
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Mater Misericordiae Ltd Mater Cancer Care Centre - Brisbane
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St Vincent's Hospital Melbourne - Fitzroy
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Sunshine Coast University Hospital - Birtinya
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Macarthur Cancer Therapy - Campbelltown
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4101 - Brisbane
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3065 - Fitzroy
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4575 - Birtinya
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2560 - Campbelltown
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Spain
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Pontevedra
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Spain
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Barcelona
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Spain
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Sevilla
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Spain
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Valencia
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United Kingdom
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England
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United Kingdom
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State/province [132]
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Hampshire
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United Kingdom
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State/province [133]
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Kent
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United Kingdom
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Somerset
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United Kingdom
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Cardiff
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United Kingdom
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London
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Funding & Sponsors
Primary sponsor type
Other
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Name
Stemline Therapeutics, Inc.
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Ethics approval
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Summary
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) .
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Trial website
https://clinicaltrials.gov/study/NCT03778931
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Trial related presentations / publications
Bidard FC, Kaklamani VG, Neven P, Streich G, Montero AJ, Forget F, Mouret-Reynier MA, Sohn JH, Taylor D, Harnden KK, Khong H, Kocsis J, Dalenc F, Dillon PM, Babu S, Waters S, Deleu I, Garcia Saenz JA, Bria E, Cazzaniga M, Lu J, Aftimos P, Cortes J, Liu S, Tonini G, Laurent D, Habboubi N, Conlan MG, Bardia A. Elacestrant (oral selective estrogen receptor degrader) Versus Standard Endocrine Therapy for Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Results From the Randomized Phase III EMERALD Trial. J Clin Oncol. 2022 Oct 1;40(28):3246-3256. doi: 10.1200/JCO.22.00338. Epub 2022 May 18. Erratum In: J Clin Oncol. 2023 Aug 10;41(23):3962. doi: 10.1200/JCO.23.01239. 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.
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Public notes
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Contacts
Principal investigator
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/31/NCT03778931/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/31/NCT03778931/SAP_003.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03778931