Clinical Trials /

Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer

NCT03155997

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

Title

  • Brief Title: A Study to Compare Treatment After Surgery of Abemaciclib (LY2835219) Combined With Standard Endocrine Therapy Versus Endocrine Therapy Alone in Participants With Breast Cancer
  • 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

Clinical Trial IDs

  • ORG STUDY ID: 16338
  • SECONDARY ID: I3Y-MC-JPCF
  • SECONDARY ID: 2016-004362-26
  • NCT ID: NCT03155997

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
AbemaciclibLY2835219Abemaciclib + Standard Adjuvant Endocrine Therapy
Standard Adjuvant Endocrine TherapyAbemaciclib + Standard Adjuvant Endocrine Therapy

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Abemaciclib + Standard Adjuvant Endocrine TherapyExperimentalAbemaciclib administered orally and standard adjuvant endocrine therapy administered according to package label.
  • Abemaciclib
  • Standard Adjuvant Endocrine Therapy
Standard Adjuvant Endocrine TherapyOtherStandard adjuvant endocrine therapy administered according to package label.
  • Standard Adjuvant Endocrine Therapy

Eligibility Criteria

        Inclusion Criteria:

          -  The participant is ≥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 surgical treatment for the current
             malignancy.

          -  The participant must have tumor tissue for biomarker analysis available prior to
             randomization.

          -  The participant must have axillary lymph node involvement by tumor and have one of
             the following indicating a higher risk of relapse:

               -  4 or more axillary lymph nodes involved with cancer

               -  Tumor size of at least 5 centimeters

               -  Grade 3 histology

               -  Ki67 index by central analysis of ≥20% (for study cohort 2)

          -  The participant must be randomized within 12 weeks of completion of last
             non-endocrine treatment.

          -  If the participant is currently receiving or initiating standard adjuvant endocrine
             therapy at time of study entry, she/he must not have received more than 8 weeks prior
             to randomization.

          -  Participants must have recovered from the acute effects of chemotherapy and
             radiotherapy and from surgical side effects following definitive breast surgery.

          -  Women regardless of menopausal status.

          -  Women of reproductive potential must have a negative serum 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:

          -  Stage IV (M1) disease (American Joint Committee on Cancer [AJCC] TNM Staging System
             for breast cancer - 7th edition).

          -  Stage IA disease (AJCC TNM Staging System for breast cancer - 7th edition).

          -  The participant has 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.

          -  Females who are pregnant or lactating.

          -  The participant has previously received treatment with any CDK4 and CDK6 inhibitor.

          -  The participant is receiving concurrent exogenous hormone therapy (for example, birth
             control pills or hormone replacement therapy).

          -  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.

          -  The participant has active bacterial infection, fungal infection, or detectable viral
             infection.

          -  The participant has received an experimental treatment in a clinical trial within the
             last 30 days or 5 half-lives, whichever is longer.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Invasive Disease Free Survival (IDFS)
Time Frame:Baseline to Recurrence or Death from Any Cause (Approximately 5 Years)
Safety Issue:
Description:IDFS

Secondary Outcome Measures

Measure:IDFS for Participants with Ki67 Index ≥20%
Time Frame:Baseline to Recurrence or Death from Any Cause (Approximately 5 Years)
Safety Issue:
Description:IDFS for participants with Ki67 index ≥20%
Measure:Distant Relapse-Free Survival (DRFS)
Time Frame:Baseline to Distant Recurrence or Death from Any Cause (Approximately 5 Years)
Safety Issue:
Description:DRFS
Measure:Overall Survival (OS)
Time Frame:Baseline to Death from Any Cause (Approximately 5 Years)
Safety Issue:
Description:OS
Measure:Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib
Time Frame:Post Dose Day 1 through Month 3
Safety Issue:
Description:PK: Cmin,ss of Abemaciclib
Measure:Change from Baseline on the Functional Assessment of Cancer Therapy - Breast (FACT-B)
Time Frame:Baseline, Follow Up (Approximately 3 Years)
Safety Issue:
Description:Change from Baseline on the FACT-B
Measure:Change from Baseline on the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)
Time Frame:Baseline, Follow Up (Approximately 3 Years)
Safety Issue:
Description:Change from Baseline on the FACT-ES
Measure:Change from Baseline on the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Time Frame:Baseline, Follow Up (Approximately 3 Years)
Safety Issue:
Description:Change from Baseline on the FACIT-F
Measure:Change from Baseline on the EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L)
Time Frame:Baseline, Follow Up (Approximately 3 Years)
Safety Issue:
Description:Change from Baseline on the EQ-5D-5L

Details

Phase:Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Eli Lilly and Company

Trial Keywords

  • early stage breast cancer
  • cyclin-dependent kinase (CDK)

Last Updated

June 13, 2017