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

ID: NCT03155997
Status: Recruiting
Phase: Phase 3
Start Date: July 12, 2017
First Submitted: May 15, 2017
Last Updated: February 23, 2018
Results: N/A
Organization: Eli Lilly and Company
Sponsors & Collaborators: Eli Lilly and Company, NSABP Foundation Inc
Location: 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, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, United States
Conditions: Breast Cancer
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Study Description

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

Condition or disease Intervention/treatment Phase

Breast Cancer

Drug: Abemaciclib
Other Names
LY2835219
Drug: Standard Adjuvant Endocrine Therapy
Other Names
Phase 3

Tracking Information

First Submitted DateMay 15, 2017
Last Update Posted DateFebruary 23, 2018
Actual Start DateJuly 12, 2017
Anticipated Completion DateJune 28, 2027
Actual Primary Completion DateJune 28, 2022
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Invasive Disease Free Survival (IDFS) [Time Frame: Baseline to Recurrence or Death from Any Cause (Approximately 10 Years)]

    IDFS

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • IDFS for Participants with Ki67 Index ≥20% [Time Frame: Baseline to Recurrence or Death from Any Cause (Approximately 10 Years)]

    IDFS for participants with Ki67 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

Not Available

Study Design

Brief TitleEndocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer
Official TitleA 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

Study TypeInterventional
Study PhasePhase 3
Estimated Enrollment
3580
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
None (Open Label)
Primary Purpose
Treatment
Conditions
Breast Cancer
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Drug: Abemaciclib

Administered orally.

Other Names
LY2835219
Drug: Standard Adjuvant Endocrine Therapy

Administered according to label instructions.

Other Names
Study Groups/Cohorts
Abemaciclib + Standard Adjuvant Endocrine Therapy
Abemaciclib administered orally and standard adjuvant endocrine therapy administered according to package label.

Standard Adjuvant Endocrine Therapy
Standard adjuvant endocrine therapy administered according to package label.

Study Arms
Experimental Abemaciclib + Standard Adjuvant Endocrine Therapy
Abemaciclib administered orally and standard adjuvant endocrine therapy administered according to package label.
Drug : Abemaciclib
Administered orally.

Experimental Abemaciclib + Standard Adjuvant Endocrine Therapy
Abemaciclib administered orally and standard adjuvant endocrine therapy administered according to package label.
Drug : Standard Adjuvant Endocrine Therapy
Administered according to label instructions.

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

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

Recruitment Information

Recruitment Status:Recruiting
Enrollment3580
Completion DateJune 28, 2027
Eligibility 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 surgical treatment for the current malignancy.
- The participant must have tumor tissue from breast (preferred) or lymph node for exploratory 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% on untreated breast tissue
- The participant must be randomized within 16 months from the time of surgery.
- 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 12 weeks of adjuvant endocrine therapy following his/her last non-endocrine therapy (surgery, chemotherapy, or radiation).
- Participants must have recovered 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:
- Stage IV (M1), Stage IA, and lymph node negative breast cancer.
- Participants with a history of previous breast cancer are excluded, with the exception of lobular carcinoma in situ (LCIS) or ductal carcinoma in situ (DCIS) treated by locoregional therapy alone ≥5 years ago. 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 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) (for example, deep vein thrombosis [DVT] of the leg or arm and/or pulmonary embolism) will be excluded.
- The participant has active bacterial infection, fungal infection, or detectable viral infection 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.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
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
Puerto Rico
Romania
Russian Federation
Saudi Arabia
Singapore
South Africa
Spain
Sweden
Taiwan
Turkey
Ukraine
United Kingdom
United States
Chile

Administrative Information

NCT Number:NCT03155997
Other Study ID Numbers
16338
I3Y-MC-JPCF
2016-004362-26
NSABP B-58
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Eli Lilly and Company
Collaborators
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