Lewiston, Maine 04240

  • Breast Neoplasms

Purpose:

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.


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)


Study is Available At:


Original ID:

17384


NCT ID:

NCT04752332


Secondary ID:

I3Y-MC-JPCW


Study Acronym:

eMonarcHER


Brief Title:

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


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 Therap


Overall Status:

Recruiting


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Eli Lilly and Company


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

2450


Enrollment Type:

Anticipated


Overall Contact Information

Official Name: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)
Study Director
Eli Lilly and Company
Primary 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

Study Dates

Start Date:May 10, 2021
Completion Date:February 28, 2033
Completion Type:Anticipated
Primary Completion Date:May 1, 2025
Primary Completion Type:Anticipated
Verification Date:May 16, 2021
Last Changed Date:May 18, 2021
First Received Date:February 11, 2021

Study Outcomes

Outcome Type:Primary Outcome
Measure:Invasive Disease Free Survival (IDFS)
Time Frame:Randomization to Recurrence or Death from Any Cause (up to 10 Years)
Safety Issues:False
Description:IDFS as defined by the STEEP System
Outcome Type:Secondary Outcome
Measure:Overall Survival (OS)
Time Frame:Randomization to Death from Any Cause (up to 10 Years)
Safety Issues:False
Description:OS
Outcome Type:Secondary Outcome
Measure:Distant Relapse-Free Survival (DRFS)
Time Frame:Randomization to Distant Recurrence or Death from Any Cause (up to 10 Years)
Safety Issues:False
Description:DRFS
Outcome Type:Secondary Outcome
Measure: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)
Safety Issues:False
Description:Percentage of Participants with CNS Metastases as First Site of Disease Recurrence
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Description: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,
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Pharmacokinetics (PK): Mean Steady State Concentrations of Abemaciclib
Time Frame:Day 1 of Cycles 1-3 (Cycle = 28 days)
Safety Issues:False
Description:PK: Mean Steady State Concentrations of Abemaciclib

Study Interventions

Intervention Type:Drug
Name:Abemaciclib
Description:Administered orally.
Arm Name:Abemaciclib Plus (+) Endocrine Therapy (ET)
Other Name:LY2835219
Intervention Type:Drug
Name:Standard Adjuvant ET
Description:Administered orally.
Arm Name:Abemaciclib Plus (+) Endocrine Therapy (ET)
Intervention Type:Drug
Name:Placebo
Description:Administered orally.
Arm Name:Placebo + ET

Study Arms

Study Arm Type:Experimental
Arm Name:Abemaciclib Plus (+) Endocrine Therapy (ET)
Description:Abemaciclib administered orally and standard adjuvant ET (physician's choice) administered according to package label.
Study Arm Type:Active Comparator
Arm Name:Placebo + ET
Description:Placebo administered orally and standard adjuvant ET (physician's choice) administered according to package label.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Eli Lilly and Company

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 24, 2021

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