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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 : Active, not recruiting
First Posted : May 16, 2017
Last Update Posted : October 17, 2019
Sponsor:
Collaborator:
NSABP Foundation Inc
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE May 15, 2017
First Posted Date  ICMJE May 16, 2017
Last Update Posted Date October 17, 2019
Actual Study Start Date  ICMJE July 12, 2017
Estimated Primary Completion Date April 12, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2017)
Invasive Disease Free Survival (IDFS) [ Time Frame: Baseline to Recurrence or Death from Any Cause (Approximately 10 Years) ]
IDFS
Original Primary Outcome Measures  ICMJE
 (submitted: May 15, 2017)
Invasive Disease Free Survival (IDFS) [ Time Frame: Baseline to Recurrence or Death from Any Cause (Approximately 5 Years) ]
IDFS
Change History Complete list of historical versions of study NCT03155997 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2017)
  • 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%
  • Distant Relapse-Free Survival (DRFS) [ Time Frame: Baseline to Distant Recurrence or Death from Any Cause (Approximately 10 Years) ]
    DRFS
  • Overall Survival (OS) [ Time Frame: Baseline to Death from Any Cause (Approximately 10 Years) ]
    OS
  • Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib [ Time Frame: Post Dose Day 1 through Month 3 ]
    PK: Cmin,ss of Abemaciclib
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2017)
  • IDFS for Participants with Ki-67 Index ≥20% [ Time Frame: Baseline to Recurrence or Death from Any Cause (Approximately 5 Years) ]
    IDFS for participants with Ki-67 index ≥20%
  • Distant Relapse-Free Survival (DRFS) [ Time Frame: Baseline to Distant Recurrence or Death from Any Cause (Approximately 5 Years) ]
    DRFS
  • Overall Survival (OS) [ Time Frame: Baseline to Death from Any Cause (Approximately 5 Years) ]
    OS
  • Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib [ Time Frame: Post Dose Day 1 through Month 3 ]
    PK: Cmin,ss of Abemaciclib
  • 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
  • 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
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Abemaciclib
    Administered orally.
    Other Name: LY2835219
  • Drug: Standard Adjuvant Endocrine Therapy
    Administered according to label instructions.
Study Arms  ICMJE
  • Experimental: Abemaciclib + Standard Adjuvant Endocrine Therapy
    Abemaciclib administered orally and standard adjuvant endocrine therapy administered according to package label.
    Interventions:
    • Drug: Abemaciclib
    • Drug: Standard Adjuvant Endocrine Therapy
  • Standard Adjuvant Endocrine Therapy
    Standard adjuvant endocrine therapy administered according to package label.
    Intervention: Drug: Standard Adjuvant Endocrine Therapy
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 25, 2019)
4580
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2017)
3580
Estimated Study Completion Date  ICMJE June 10, 2027
Estimated Primary Completion Date April 12, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 aromatase inhibitors) or raloxifene.
  • 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.
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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   China,   Czechia,   Denmark,   Finland,   France,   Germany,   Greece,   Hong Kong,   Hungary,   India,   Israel,   Italy,   Japan,   Korea, Republic of,   Mexico,   Netherlands,   New Zealand,   Poland,   Portugal,   Puerto Rico,   Romania,   Russian Federation,   Saudi Arabia,   Singapore,   South Africa,   Spain,   Sweden,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Chile
 
Administrative Information
NCT Number  ICMJE NCT03155997
Other Study ID Numbers  ICMJE 16338
I3Y-MC-JPCF ( Other Identifier: Eli Lilly and Company )
2016-004362-26 ( EudraCT Number )
NSABP B-58 ( Other Identifier: NSABP )
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 NSABP Foundation Inc
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 2019

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