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Trial record 1 of 1 for:    NCT03155997
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Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer (monarchE)

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ClinicalTrials.gov Identifier: NCT03155997
Recruitment Status : Recruiting
First Posted : May 16, 2017
Last Update Posted : December 4, 2018
Sponsor:
Collaborator:
NSABP Foundation Inc
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Abemaciclib Drug: Standard Adjuvant Endocrine Therapy Phase 3

Expanded Access : An investigational treatment associated with this study has been approved for sale to the public.   More info ...

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4580 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone in Patients With High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer
Actual Study Start Date : July 12, 2017
Estimated Primary Completion Date : April 12, 2021
Estimated Study Completion Date : June 10, 2027

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Abemaciclib + Standard Adjuvant Endocrine Therapy
Abemaciclib administered orally and standard adjuvant endocrine therapy administered according to package label.
Drug: Abemaciclib
Administered orally.
Other Name: LY2835219

Drug: Standard Adjuvant Endocrine Therapy
Administered according to label instructions.

Standard Adjuvant Endocrine Therapy
Standard adjuvant endocrine therapy administered according to package label.
Drug: Standard Adjuvant Endocrine Therapy
Administered according to label instructions.




Primary Outcome Measures :
  1. Invasive Disease Free Survival (IDFS) [ Time Frame: Baseline to Recurrence or Death from Any Cause (Approximately 10 Years) ]
    IDFS


Secondary Outcome Measures :
  1. IDFS for Participants with Ki-67 Index ≥20% [ Time Frame: Baseline to Recurrence or Death from Any Cause (Approximately 10 Years) ]
    IDFS for participants with Ki-67 index ≥20%

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

  3. Overall Survival (OS) [ Time Frame: Baseline to Death from Any Cause (Approximately 10 Years) ]
    OS

  4. Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib [ Time Frame: Post Dose Day 1 through Month 3 ]
    PK: Cmin,ss of Abemaciclib

  5. Change from Baseline on the Functional Assessment of Cancer Therapy - Breast (FACT-B) [ Time Frame: Baseline, Follow Up (Approximately 3 Years) ]
    Change from Baseline on the FACT-B

  6. Change from Baseline on the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) [ Time Frame: Baseline, Follow Up (Approximately 3 Years) ]
    Change from Baseline on the FACT-ES

  7. Change from Baseline on the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) [ Time Frame: Baseline, Follow Up (Approximately 3 Years) ]
    Change from Baseline on the FACIT-F

  8. Change from Baseline on the EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L) [ Time Frame: Baseline, Follow Up (Approximately 3 Years) ]
    Change from Baseline on the EQ-5D-5L



Information from the National Library of Medicine

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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:

  • Women (regardless of menopausal status) or men ≥18 years of age (or per local regulations).
  • The participant has confirmed HR+, HER2-, early stage resected invasive breast cancer without evidence of distant metastases.
  • The participant must have undergone definitive surgery of the primary breast tumor.
  • The participant must have tumor tissue from breast (preferred) or lymph node for exploratory biomarker analysis available prior to randomization.
  • Pathologic lymph node involvement and at least one of the following indicating a higher risk of recurrence:

    • 4 or more positive axillary lymph nodes
    • Tumor size of at least 5 centimeters
    • Grade 3 defined as at least 8 points on the Bloom Richardson grading system
    • Ki-67 index by central analysis of ≥20% on untreated breast tissue
  • The participant must be randomized within 16 months from the time of definitive breast cancer surgery.
  • The participant may receive up to 12 weeks of endocrine therapy until randomization following the last non-endocrine therapy (surgery, chemotherapy, or radiation) whichever is last.
  • Participants must have recovered (grade ≤1) from the acute effects of chemotherapy and radiotherapy and from surgical side effects following definitive breast surgery.
  • Women of reproductive potential must have a negative blood pregnancy test and agree to use highly effective contraceptive methods.
  • The participant has a Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
  • The participant has adequate organ function.
  • The participant is able to swallow oral medications.

Exclusion Criteria:

  • Metastatic disease (including contralateral axillary lymph nodes) or node-negative disease.
  • Participants with inflammatory breast cancer.
  • Participants with a history of previous breast cancer, with the exception of ipsilateral ductal carcinoma in situ (DCIS) treated by locoregional therapy alone ≥5 years ago. Participants with a history of contralateral DCIS treated by local regional therapy at any time may be eligible. Participants with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 5 years from the date of randomization are excluded.
  • Females who are pregnant or lactating.
  • The participant has previously received treatment with any CDK4 and CDK6 inhibitor.
  • The participant is receiving concurrent exogenous reproductive hormone therapy (for example, birth control pills, hormone replacement therapy, or megestrol acetate).
  • The participant has previously received endocrine therapy for breast cancer prevention (tamoxifen or raloxifene or aromatase inhibitors).
  • The participant has serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
  • The participant has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin or sudden cardiac arrest. Any participant with a history of venous thromboembolism (VTE).
  • The participant has active systemic infections or viral load.
  • The participant has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer.

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): NCT03155997


Contacts
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

  Show 634 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
NSABP Foundation Inc
Investigators
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

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03155997     History of Changes
Other Study ID Numbers: 16338
I3Y-MC-JPCF ( Other Identifier: Eli Lilly and Company )
2016-004362-26 ( EudraCT Number )
NSABP B-58 ( Other Identifier: NSABP )
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eli Lilly and Company:
early stage breast cancer
cyclin-dependent kinase (CDK)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases