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A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer (eMonarcHER)

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ClinicalTrials.gov Identifier: NCT04752332
Recruitment Status : Recruiting
First Posted : February 12, 2021
Last Update Posted : October 18, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE February 11, 2021
First Posted Date  ICMJE February 12, 2021
Last Update Posted Date October 18, 2021
Actual Study Start Date  ICMJE May 10, 2021
Estimated Primary Completion Date May 1, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2021)
Invasive Disease Free Survival (IDFS) [ Time Frame: Randomization to Recurrence or Death from Any Cause (up to 10 Years) ]
IDFS as defined by the STEEP System
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2021)
  • Overall Survival (OS) [ Time Frame: Randomization to Death from Any Cause (up to 10 Years) ]
    OS
  • Distant Relapse-Free Survival (DRFS) [ Time Frame: Randomization to Distant Recurrence or Death from Any Cause (up to 10 Years) ]
    DRFS
  • Percentage of Participants with Central Nervous System (CNS) Metastases as First Site of Disease Recurrence [ Time Frame: Randomization to Distant Recurrence or Death from Any Cause (up to 10 Years) ]
    Percentage of Participants with CNS Metastases as First Site of Disease Recurrence
  • Change from Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Scale Score [ Time Frame: Cycle 1 up to end of Year 4 ]
    EORTC QLQ-C30 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.
  • Change from Baseline in the EuroQOL 5 Dimension 5 Level (EQ-5D 5L) Index Score [ Time Frame: Cycle 1 up to end of Year 4 ]
    The EQ-5D is a self-administered questionnaire that participants complete to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a scale from 1 to 5 (no problem, slight problems, moderate problems, severe problems, and extreme problems/unable to, respectively). These combinations of attributes were converted into a weighted Health State Index score; the possible values for the Health State Index score range from less than 0 (0 equals health state of "dead"; severe problems in all 5 dimensions) to 1.0 (full health; no problem in any dimension). Higher score indicates better health state.
  • Pharmacokinetics (PK): Mean Steady State Concentrations of Abemaciclib [ Time Frame: Day 1 of Cycles 1-3 (Cycle = 28 days) ]
    PK: Mean Steady State Concentrations of Abemaciclib
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Breast Neoplasms
Intervention  ICMJE
  • Drug: Abemaciclib
    Administered orally.
    Other Name: LY2835219
  • Drug: Standard Adjuvant ET
    Administered according to label instructions.
  • Drug: Placebo
    Administered orally.
Study Arms  ICMJE
  • Experimental: Abemaciclib Plus (+) Endocrine Therapy (ET)
    Abemaciclib administered orally and standard adjuvant ET (physician's choice) administered according to package label.
    Interventions:
    • Drug: Abemaciclib
    • Drug: Standard Adjuvant ET
  • Active Comparator: Placebo + ET
    Placebo administered orally and standard adjuvant ET (physician's choice) administered according to package label.
    Interventions:
    • Drug: Standard Adjuvant ET
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 11, 2021)
2450
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2033
Estimated Primary Completion Date May 1, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have confirmed HR+, HER2+ in initial diagnostic tissue, 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 therapy
  • Have completed approximately nine months to one year of standard HER2-targeted therapy without evidence of disease recurrence (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 (chemotherapy administered with HER2-targeted therapy): Single agent adjuvant ado-trastuzumab emtansine or
    • For participants not treated with neoadjuvant therapy: Adjuvant pertuzumab with trastuzumab
  • Have high risk disease, defined by one of the following:

    • For participants treated with neoadjuvant therapy (as defined above): Pathologically detected axillary nodal disease in the surgical specimen
    • For participants not treated with neoadjuvant therapy: Axillary node positive disease meeting one of the following criteria:

      • Pathological tumor involvement in greater than or equal to (≥) four ipsilateral axillary lymph nodes OR
      • Pathological tumor involvement in one to three ipsilateral axillary lymph node(s) and at least 1 of the following criteria:

        • Histological Grade 3
        • Primary invasive tumor size ≥5 centimeters determined pathologically

Exclusion Criteria:

  • Have breast cancer with any of the following features:

    • Disease recurrence or distant metastatic disease (including contralateral axillary lymph nodes)
    • Lymph node-negative status
    • Pathological complete response from any prior systemic treatments for early breast cancer
    • 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, investigational HER2 directed therapy, or trastuzumab deruxtecan 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 therapy for their breast cancer at study enrollment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   China,   Finland,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Puerto Rico,   Romania,   Russian Federation,   Spain,   Sweden,   Switzerland,   Taiwan,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04752332
Other Study ID Numbers  ICMJE 17384
I3Y-MC-JPCW ( Other Identifier: Eli Lilly and Company )
2020-004035-24 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: 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) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP