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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05514054




Registration number
NCT05514054
Ethics application status
Date submitted
23/08/2022
Date registered
24/08/2022
Date last updated
25/06/2024

Titles & IDs
Public title
A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer
Scientific title
EMBER-4: A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients Who Have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer With an Increased Risk of Recurrence
Secondary ID [1] 0 0
J2J-MC-JZLH
Secondary ID [2] 0 0
18459
Universal Trial Number (UTN)
Trial acronym
EMBER-4
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Imlunestrant
Treatment: Drugs - Tamoxifen
Treatment: Drugs - Anastrozole
Treatment: Drugs - Letrozole
Treatment: Drugs - Exemestane

Experimental: Imlunestrant - Imlunestrant administered orally.

Active comparator: Investigator's Choice of Endocrine Therapy - Investigator's choice of tamoxifen, anastrozole, letrozole, or exemestane administered per local approved label.


Treatment: Drugs: Imlunestrant
Administered orally.

Treatment: Drugs: Tamoxifen
Administered per local approved label.

Treatment: Drugs: Anastrozole
Administered per local approved label.

Treatment: Drugs: Letrozole
Administered per local approved label.

Treatment: Drugs: Exemestane
Administered per local approved label.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Invasive Disease-Free Survival (IDFS)
Timepoint [1] 0 0
Randomization to recurrence or death from any cause (up to 10 years)
Secondary outcome [1] 0 0
Distant Recurrence-Free Survival (DRFS)
Timepoint [1] 0 0
Randomization to Distant Recurrence or Death from Any Cause (up to 10 Years)
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Randomization to Death from Any Cause (up to 10 Years)
Secondary outcome [3] 0 0
Pharmacokinetics (PK): Steady State Plasma Concentrations of Imlunestrant
Timepoint [3] 0 0
Year 1, Month 2 to Month 4
Secondary outcome [4] 0 0
Change from Baseline in the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (EORTC QLQ-C30) Physical Functioning
Timepoint [4] 0 0
Visit 1 Day 1 up to end of Year 5
Secondary outcome [5] 0 0
Change from Baseline in the EORTC QLQ-C30 Role Functioning
Timepoint [5] 0 0
Visit 1 Day 1 up to end of Year 5
Secondary outcome [6] 0 0
Change from Baseline in the EORTC QLQ-C30 Global QOL
Timepoint [6] 0 0
Visit 1 Day 1 up to end of Year 5
Secondary outcome [7] 0 0
Proportion of Time on Study Treatment with High Overall Adverse Event Burden
Timepoint [7] 0 0
Visit 1 Day 1 up to end of Year 5

Eligibility
Key inclusion criteria
* Have a diagnosis of ER+, HER2- early-stage, resected, invasive breast cancer without evidence of distant metastasis.
* Participants must have received at least 24 months but not more than 60 months of any adjuvant ET, from time of adjuvant ET initiation.
* Participants may have received (neo) adjuvant chemotherapy and/or targeted therapy with a CDK4/6- or PARP- inhibitor.
* Must have an increased risk of disease recurrence based on clinical-pathological risk features.
* Have a Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group scale.
* Have adequate organ function.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Have any evidence of metastatic disease (including contralateral ALN) or inflammatory breast cancer at primary breast cancer diagnosis.
* Participants with more than a 6-month consecutive gap in therapy during the course of prior adjuvant ET.
* Participants who have completed or discontinued prior adjuvant ET >6 months prior to screening.
* Participants with a history of previous breast cancer are excluded, with the exception of ipsilateral DCIS treated by locoregional therapy alone =5 years ago.
* Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of study intervention.
* Participant has previously received ET of any duration for breast cancer prevention (tamoxifen or AIs) or raloxifene.
* Participants with a history of any other cancer.
* Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study.

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
4/10/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/03/2032
Actual
Sample size
Target
6000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,NT,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Coffs Harbour Health Campus - Coffs Harbour
Recruitment hospital [2] 0 0
St Vincent's Hospital - Darlinghurst
Recruitment hospital [3] 0 0
Gosford Hospital - Gosford
Recruitment hospital [4] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [5] 0 0
Lake Macquarie Private Hospital - Newcastle
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Mater Hospital Sydney - Sydney
Recruitment hospital [7] 0 0
Royal Darwin Hospital - Tiwi
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Mackay Base Hospital - Mackay
Recruitment hospital [9] 0 0
Gold Coast University Hospital - Southport
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The Townsville Hospital - Townsville
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Hervey Bay Hospital - Urraween
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The Queen Elizabeth Hospital - Woodville
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Royal Hobart Hospital - Hobart
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Launceston General Hospital - Launceston
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Ballarat Health Services - Ballarat Central
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Box Hill Hospital - Box Hill
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Monash Health - Clayton
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Barwon Health - Geelong
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St Vincent's Hospital - Melbourne
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Northern Hospital - Melbourne
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Maroondah Hospital - Melbourne
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Goulburn Valley Health - Shepparton
Recruitment hospital [23] 0 0
Breast Cancer Research Centre-WA - Nedlands
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
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2010 - Darlinghurst
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2250 - Gosford
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2170 - Liverpool
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2290 - Newcastle
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2060 - Sydney
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0810 - Tiwi
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4740 - Mackay
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4215 - Southport
Recruitment postcode(s) [10] 0 0
4814 - Townsville
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4655 - Urraween
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5011 - Woodville
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7000 - Hobart
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7250 - Launceston
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3350 - Ballarat Central
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3128 - Box Hill
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3168 - Clayton
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3220 - Geelong
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3065 - Melbourne
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3076 - Melbourne
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3135 - Melbourne
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3630 - Shepparton
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6009 - Nedlands
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Reading

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years.
Trial website
https://clinicaltrials.gov/study/NCT05514054
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Address 0 0
Country 0 0
Phone 0 0
1-317-615-4559
Fax 0 0
Email 0 0
ClinicalTrials.gov@lilly.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05514054