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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04752332
Registration number
NCT04752332
Ethics application status
Date submitted
11/02/2021
Date registered
12/02/2021
Date last updated
15/07/2025
Titles & IDs
Public title
A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer
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Scientific title
eMonarcHER: A Randomized, Double Blind, Placebo-Controlled Phase 3 Study of Abemaciclib Plus Standard Adjuvant Endocrine Therapy in Participants With High-Risk, Node-Positive, HR+, HER2+ Early Breast Cancer Who Have Completed Adjuvant HER2-Targeted Therapy
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Secondary ID [1]
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I3Y-MC-JPCW
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Secondary ID [2]
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17384
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Universal Trial Number (UTN)
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Trial acronym
eMonarcHER
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms
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0
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Condition category
Condition code
Cancer
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0
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0
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Breast
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Intervention/exposure
Study type
Interventional(has expanded access)
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Description of intervention(s) / exposure
Treatment: Drugs - Abemaciclib
Treatment: Drugs - Standard Adjuvant ET
Treatment: Drugs - Placebo
Experimental: 150 mg Abemaciclib + Endocrine Therapy (ET) - Participants received 150 milligrams (mg) of abemaciclib administered twice daily (BID) orally along with standard adjuvant endocrine therapy (ET).
Active comparator: Placebo + ET - Participants received placebo administered BID orally along with standard adjuvant ET.
Treatment: Drugs: Abemaciclib
Administered orally.
Treatment: Drugs: Standard Adjuvant ET
Administered according to label instructions.
Treatment: Drugs: Placebo
Administered orally.
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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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Invasive Disease Free Survival (IDFS)
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Assessment method [1]
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IDFS, as defined by the STEEP System, is measured from the date of randomization to the date of first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer, death attributable to any cause. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
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Timepoint [1]
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Randomization to Recurrence or Death from Any Cause (up to 890 days)
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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OS is defined as the time from randomization until death from any cause. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
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Timepoint [1]
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Randomization to Death from Any Cause (up to 890 days)
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Secondary outcome [2]
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Distant Relapse-Free Survival (DRFS)
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Assessment method [2]
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DRFS is defined as the time from randomization to distant recurrence or death from any cause, whichever occurs first. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
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Timepoint [2]
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Randomization to Distant Recurrence or Death from Any Cause (up to 890 days)
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Secondary outcome [3]
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Percentage of Participants With Central Nervous System (CNS) Metastases as First Site of Disease Recurrence
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Assessment method [3]
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Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
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Timepoint [3]
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Randomization to Distant Recurrence or Death from Any Cause (up to 890 days)
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Secondary outcome [4]
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Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scale Score
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Assessment method [4]
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The EORTC QLQ-C30 (v. 3.0) is a self-administered, cancer-specific questionnaire with multidimensional scales assessing 15 domains (5 functional domains, 9 symptoms, and global health status). A linear transformation will be applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For the functional domains and global health status scale, higher scores represent a better level of functioning. For symptom scales, higher scores represent a greater degree of symptoms. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
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Timepoint [4]
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Cycle 1 up to 390 days
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Secondary outcome [5]
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Change From Baseline in the EuroQOL 5 Dimension 5 Level (EQ-5D 5L) Index Score
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Assessment method [5]
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The EQ-5D-5L is a standardized instrument for use as a measure of self-reported health status. Participants completed the 5-level (no problem, slight problem, moderate problem, severe problem, and inability or extreme problem), 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire concerning their current health state. Five dimensions of health status are each assessed with 5 response options and scored as a composite index which are anchored on a scale of 0 to 1 with a higher score representing better health status. Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
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Timepoint [5]
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Cycle 1 up to 390 days
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Secondary outcome [6]
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Pharmacokinetics (PK): Mean Steady State Concentrations of Abemaciclib
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Assessment method [6]
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Study was terminated early. Data was not collected for this outcome and outcome measures were not assessed.
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Timepoint [6]
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Day 1 of Cycles 1-3 (Cycle = 28 days)
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Eligibility
Key inclusion criteria
* Have confirmed HR+, HER2+ early invasive breast cancer without evidence of disease recurrence or distant metastases
* Have undergone definitive surgery of the primary breast tumor(s)
* Have tumor tissue from breast (preferred) or lymph node
* Have received a minimum of four cycles of chemotherapy in either the neoadjuvant or adjuvant setting per standard of care
* Have completed approximately nine to 20 months of standard HER2-targeted therapy (neoadjuvant/adjuvant combined duration)
* Have received one of the following eligible HER2-targeted adjuvant regimens AND be randomized within 12 weeks of completing the regimen:
* For participants treated with neoadjuvant therapy and HER2-targeted therapy: A minimum of 4 cycles of T-DM1 in the adjuvant setting. NOTE: Participants may have received up to approximately 6 cycles of adjuvant trastuzumab prior to initiation of T-DM1. Additionally, participants may have switched to trastuzumab-based therapy (monotherapy or in combination with other HER2-targeted therapies) after 4 cycles of T-DM1
* For participants who had definitive surgery prior to systemic therapy, a minimum of 4 cycles of adjuvant pertuzumab with trastuzumab.
* Have high risk disease, defined by one of the following criteria:
* Those who received neoadjuvant chemotherapy along with HER2-targeted treatment must have:
* residual disease in at least one axillary lymph node, or
* a residual tumor = 5 cm, or
* a residual tumor of any size that has direct extension to the chest wall and/or skin (ulceration or skin nodules).
* Those who had definitive surgery prior to systemic therapy and completed adjuvant chemotherapy along with HER2-targeted therapies (trastuzumab and pertuzumab) must have
* tumor involvement in =4 ipsilateral axillary lymph nodes, or
* tumor involvement in 1 to 3 ipsilateral axillary lymph node(s) and histological Grade 3, or
* primary invasive tumor size of = 5 cm on pathological evaluation.
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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
* Have breast cancer with any of the following features:
* Disease recurrence or distant metastatic disease (including contralateral axillary lymph nodes)
* Pathological complete response from any prior early breast cancer treatments. Participants are required to have residual primary tumor and/or lymph node disease at the time of definitive surgery as indicated in inclusion criteria.
* Inflammatory breast cancer
* Have other medical conditions including:
* Previous breast cancer (Exceptions: Ipsilateral ductal carcinoma in situ [DCIS] treated by locoregional therapy alone =5 years ago; contralateral DCIS treated by locoregional therapy at any time)
* Other cancer being treated and/or not in complete remission within the last 5 years (Exceptions: Appropriately treated non-melanomatous skin cancer or carcinoma in situ of cervix, bladder, or colon)
* Females who are pregnant or lactating
* History of venous thromboembolism
* Other serious medical conditions
* Have previously received treatment with:
* Any cyclin-dependent kinase (CDK)4 and CDK6 inhibitor
* Prior adjuvant treatment with immunotherapy, tucatinib, neratinib, any investigational HER2 directed therapy, or T-DXd (DS8201) for treatment of breast cancer
* Endocrine therapy (ET) (i.e., tamoxifen, raloxifene or aromatase inhibitor) for breast cancer prevention (without diagnosis of breast cancer)
* Additional chemotherapy, anti-cancer ET, or HER2-targeted therapy beyond standard of care at study enrollment
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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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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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
Stopped early
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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
10/05/2021
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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
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Actual
26/06/2024
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Sample size
Target
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Accrual to date
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Final
111
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Calvary Mater Newcastle - Waratah
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Recruitment hospital [2]
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Peter MacCallum Cancer Centre - Melbourne
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2298 - Waratah
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Recruitment postcode(s) [2]
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3000 - Melbourne
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Recruitment outside Australia
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Eli Lilly and Company
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Address
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Ethics approval
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Summary
Brief summary
The main purpose of this study is to measure how well abemaciclib works in participants with early breast cancer who are taking hormone therapy after surgery. Participants must have breast cancer that is hormone receptor positive (HR+) and human epidermal receptor 2 positive (HER2+). Your participation could last up to 10 years depending on how you and your tumor respond.
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Trial website
https://clinicaltrials.gov/study/NCT04752332
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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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)
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Address
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Eli Lilly and Company
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/32/NCT04752332/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/32/NCT04752332/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04752332
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