Standard Adjuvant Endocrine Therapy: Administered according to label instructions.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Invasive Disease Free Survival (IDFS) — Baseline to Recurrence or Death from Any Cause (Up to 32 Months) IDFS, as defined by the STEEP System, was measured from the date of randomization to the date of first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer, death attributable to any cause.
Trial sites (619)
Facility
City
Region
Status
University of Alabama Birmingham
Birmingham
Alabama
Providence Alaska Medical Center
Anchorage
Alaska
Banner MD Anderson Cancer Center
Gilbert
Arizona
Arizona Oncology Associates, P.C. - HOPE
Goodyear
Arizona
St. Joseph's Hospital and Medical Center
Phoenix
Arizona
Mayo Clinic Hospital
Phoenix
Arizona
The University of Arizona Cancer Center
Tucson
Arizona
Yuma Regional Cancer Center
Yuma
Arizona
St. Bernards Medical Center
Jonesboro
Arkansas
Highlands Oncology Group
Springdale
Arkansas
Beverly Hills Cancer Center
Beverly Hills
California
Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center
Burbank
California
City of Hope National Medical Center
Duarte
California
California Cancer Associates Research and Excellence
Fresno
California
Kaiser Permanente
Harbor City
California
Loma Linda University School of Medicine
Loma Linda
California
Cedars-Sinai Medical Center
Los Angeles
California
Pacific Cancer Care
Monterey
California
St. Joseph Hospital
Orange
California
University of California Davis (UC Davis) Comprehensive Cancer Center
Sacramento
California
UCSF Medical Center at Mission Bay
San Francisco
California
California Cancer Associates in Research and Excellence
San Marcos
California
Dignity Health Dominican Oncology and Hematology
Santa Cruz
California
Kaiser Permanente
Vallejo
California
USO-Rocky Mountain Cancer Center
Boulder
Colorado
USO-Rocky Mountain Cancer Center
Thornton
Colorado
Yale-New Haven Hospital
New Haven
Connecticut
Florida Cancer Specialists - South
Fort Myers
Florida
University of Florida College of Medicine
Gainesville
Florida
Millennium Oncology - Hollywood
Hollywood
Florida
Mayo Clinic in Florida
Jacksonville
Florida
Cancer Specialists of North Florida
Jacksonville
Florida
Florida Cancer Specialists - North
Lecanto
Florida
Ocala Oncology, P.A.
Ocala
Florida
Tallahassee Memorial Cancer Center
Tallahassee
Florida
Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
Tampa
Florida
University Cancer & Blood Center, LLC
Athens
Georgia
Northside Hospital
Atlanta
Georgia
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
Marietta
Georgia
Summit Cancer Care DBA Candler Medical Oncology Practice
Savannah
Georgia
+ 579 more sites — see the full list on the official registry below.
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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