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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
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
Secondary ID [1] 0 0
RAD1901-308
Universal Trial Number (UTN)
Trial acronym
EMERALD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival in ESR1-mut Subjects
Timepoint [1] 0 0
From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months)
Primary outcome [2] 0 0
Progression-free Survival in All Subjects
Timepoint [2] 0 0
From Date of Randomization until Disease Progression or Death Due to Any Cause (up to 12 Months)
Secondary outcome [1] 0 0
Overall Survival in ESR1-mut Subjects
Timepoint [1] 0 0
From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months)
Secondary outcome [2] 0 0
Overall Survival in All Subjects
Timepoint [2] 0 0
From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/05/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2024
Actual
Sample size
Target
Accrual to date
Final
478
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Mater Misericordiae Ltd Mater Cancer Care Centre - Brisbane
Recruitment hospital [2] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [3] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [4] 0 0
Macarthur Cancer Therapy - Campbelltown
Recruitment postcode(s) [1] 0 0
4101 - Brisbane
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy
Recruitment postcode(s) [3] 0 0
4575 - Birtinya
Recruitment postcode(s) [4] 0 0
2560 - Campbelltown
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Other
Name
Stemline Therapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
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Address 0 0
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Phone 0 0
Fax 0 0
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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
What data in particular will be shared?
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03778931