Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer
Trial Status: Closed to Accrual
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.
- 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.
- 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.
University of Alabama at Birmingham Cancer Center
Contact: Carla Isadora Falkson
Mayo Clinic in Arizona
Banner University Medical Center - Tucson
Contact: Elizabeth Jennie Collins
City of Hope Comprehensive Cancer Center
University of California Davis Comprehensive Cancer Center
UCSF Medical Center-Mount Zion
Contact: Trisha Burrello
Mayo Clinic in Florida
Moffitt Cancer Center
Contact: Hung T. Khong
Queen's Cancer Cenrer - POB I
Queen's Cancer Center - Kuakini
Brigham and Women's Hospital
Dana-Farber Cancer Institute
Dana-Farber / Brigham and Women's Cancer Center at Milford Regional
Dana-Farber / Brigham and Women's Cancer Center at South Shore
Mayo Clinic in Rochester
Dartmouth Hitchcock Medical Center
The Dana-Farber Cancer Institute at Londonderry
Memorial Sloan Kettering Cancer Center
Contact: Sarat Chandarlapaty
Wake Forest University Health Sciences
Case Comprehensive Cancer Center
OHSU Knight Cancer Institute
University of Pittsburgh Cancer Institute (UPCI)
Asplundh Cancer Pavilion
Medical University of South Carolina
UT Southwestern / Simmons Cancer Center-Dallas
Contact: Marcella West Aguilar
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
Contact: Sonia Lisa Creighton
Virginia Commonwealth University / Massey Cancer Center
Contact: Kimberly Garnett
Trial Phase Phase III
Trial Type Treatment
Eli Lilly and Company
- Primary ID 16338
- Secondary IDs NCI-2017-01451, 2016-004362-26, I3Y-MC-JPCF, NSABP B-58
- Clinicaltrials.gov ID NCT03155997