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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04752332
Recruitment Status : Active, not recruiting
First Posted : February 12, 2021
Last Update Posted : May 26, 2022
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
Actual Study Start Date : May 10, 2021
Estimated Primary Completion Date : February 9, 2024
Estimated Study Completion Date : February 9, 2024

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

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+ 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.

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
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


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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Additional 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 26, 2022
Last Verified: May 2022
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