Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer
a study on Breast Cancer
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.
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
Breast Cancer early stage breast cancer cyclin-dependent kinase (CDK) Breast Neoplasms
You can join if…
Open to people ages 18 years and up
- 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.
You CAN'T join if...
- 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.
- Univ of California San Francisco not yet accepting patients
San Francisco, California, 94115, United States
- California Cancer Associates Research and Excellence (cCARE) accepting new patients
Fresno, California, 93720, United States
- Kaiser Permanente not yet accepting patients
Vallejo, California, 94589, United States
- Dignity Health Dominican Oncology and Hematology accepting new patients
Santa Cruz, California, 95065, United States
- University of California, Davis - Health Systems accepting new patients
Sacramento, California, 95817, United States
- Pacific Cancer Care accepting new patients
Monterey, California, 93940, United States
- Cancer Center of Santa Barbara with Sansum Clinic accepting new patients
Santa Barbara, California, 93105, United States
- Providence St. Joseph's Medical Center accepting new patients
Burbank, California, 91505, United States
- Cedars Sinai Medical Center not yet accepting patients
Los Angeles, California, 90048, United States
- Beverly Hills Cancer Center accepting new patients
Beverly Hills, California, 90211, United States
- St. Joseph Hospital not yet accepting patients
Santa Ana, California, 92705, United States
- Loma Linda University School of Medicine accepting new patients
Loma Linda, California, 92350, United States
- Loma Linda University School of Medicine not yet accepting patients
Loma Linda, California, 92354, United States
- Comprehensive Cancer Centers of Nevada not yet accepting patients
Las Vegas, Nevada, 89169, United States
- California Cancer Associates in Research and Excellence accepting new patients
San Marcos, California, 92069, United States
- accepting new patients
- Start Date
- Completion Date
- Eli Lilly and Company
- Click here for more information about this study: A Study to Compare Treatment After Surgery of Abemaciclib (LY2835219) Combined With Standard Endocrine Therapy Versus Endocrine Therapy Alone in Participants With Breast Cancer (monarchE)
- Phase 3
- Study Type
- Last Updated
- May 16, 2018
Please contact me about this study
We will not share your information with anyone other than the team in charge of this study. Submitting your contact information does not obligate you to participate in research.
The study team should get back to you in a few business days.
You will also receive an email with next steps. Check your junk/spam folder if needed.
If you do not hear from the study team, please call 888-689-8273 and tell them you’re interested in study number NCT03155997.