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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 : Not yet recruiting
First Posted : February 12, 2021
Last Update Posted : May 10, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: Abemaciclib Drug: Standard Adjuvant ET Drug: Placebo Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Estimated Study Start Date : May 12, 2021
Estimated Primary Completion Date : May 1, 2025
Estimated Study Completion Date : February 28, 2033

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Abemaciclib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Abemaciclib Plus (+) Endocrine Therapy (ET)
Abemaciclib administered orally and standard adjuvant ET (physician's choice) administered according to package label.
 Drug: Abemaciclib
Administered orally.
Other Name: LY2835219

Drug: Standard Adjuvant ET
Administered orally.
Active Comparator: Placebo + ET
Placebo administered orally and standard adjuvant ET (physician's choice) administered according to package label.
 Drug: Standard Adjuvant ET
Administered orally.

Drug: Placebo
Administered orally.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Randomization to Death from Any Cause (up to 10 Years) ]
    OS

  2. Distant Relapse-Free Survival (DRFS) [ Time Frame: Randomization to Distant Recurrence or Death from Any Cause (up to 10 Years) ]
    DRFS

  3. 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

  4. 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.

  5. 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.

  6. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 at least nine months and up 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 with trastuzumab-based 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 2 or 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
    • Bone-targeting agents prescribed as cancer modifying treatment agent (It is permitted as treatment for prevention of osteoporosis)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04752332


Contacts
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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

Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
More Information
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04752332    
Other Study ID Numbers: 17384
I3Y-MC-JPCW ( Other Identifier: Eli Lilly and Company )
2020-004035-24 ( EudraCT Number )
First Posted: February 12, 2021    Key Record Dates
Last Update Posted: May 10, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases