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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03778931




Registration number
NCT03778931
Ethics application status
Date submitted
3/12/2018
Date registered
19/12/2018
Date last updated
4/05/2020

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 (PFS) in the ESR1-mut subjects - Progression Free Survival (PFS) based on blinded IRC assessment in the 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
PFS in all (ESR1-mut and ESR1-WT) subjects - PFS based on blinded Imaging Review Committee (IRC) assessment in all (ESR1-mut and ESR1-WT) 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
Objective Survival (OS) in ESR1-mut subjects - OS in ESR1-mut subjects, where OS is defined as the length of time from randomization until the date of death from any cause
Timepoint [1] 0 0
From Date of Randomization until Death Due to Any Cause (Estimated up to 24 Months)
Secondary outcome [2] 0 0
OS in all (ESR1-mut and ESR1-WT) subjects - OS in all (ESR1-mut and ESR1-WT) 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
before subject is randomized.

Critical
Minimum age
18 Years
Maximum age
No limit
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Bankstown Cancer Centre - Bankstown
Recruitment hospital [2] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [3] 0 0
Macarthur Cancer Therapy - Campbelltown
Recruitment hospital [4] 0 0
St Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [5] 0 0
Royal Hobart Hospital - Hobart
Recruitment postcode(s) [1] 0 0
2200 - Bankstown
Recruitment postcode(s) [2] 0 0
4575 - Birtinya
Recruitment postcode(s) [3] 0 0
2560 - Campbelltown
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3065 - Fitzroy
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7000 - Hobart
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Wigan

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Radius Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

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) .
Trial website
https://clinicaltrials.gov/show/NCT03778931
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sr. Director, Clinical Operations
Address 0 0
Radius Health, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Director, Clinical Operations
Address 0 0
Country 0 0
Phone 0 0
1-855-672-3487
Fax 0 0
Email 0 0
clinopsinfo@radiuspharm.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03778931