Clinical Trial TitleA Randomized, Double Blind, Placebo-Controlled Phase 3 Study of Abemaciclib plus Standard Adjuvant Endocrine Therapy in Participants with High-Risk, Node-Positive, HR+, HER2+ Early Breast Cancer Who Have Completed Adjuvant HER2-Targeted Therapy
National Clinical Trial Number:04752332
Clinical Trial Protocol Description:
The purpose of this study is to find out whether there is a benefit to adding an investigational drug, abemaciclib, to hormone therapy for participants with hormone receptor positive (HR+), human epidermal growth factor receptor-2 positive (HER2+) breast cancer who are at high risk of disease recurrence.
“Investigational” means that the drug being tested has not been approved for routine clinical use or for the use described in this study by the United States Food and Drug Administration (FDA) and it must be tested to see if it is a safe and effective treatment for the disease or condition being studied. The FDA is allowing the use of abemaciclib for this research.
If you qualify to participate in this study, your participation may last up 5-10 years and the length of your participation will depend on how well your disease responds to the study treatment and how many cycles of treatment you receive. You will be asked to complete about 12 in-person study visits and receive treatment for up to 26 cycles (around 2 years).
More information can be found on the clinicaltrials.gov website and by searching for NCT04752332.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Male or female participant must be at least 18 years of age.
- The participant has confirmed HR+, HER2-positive (HER2+) in initial diagnostic tissue, early invasive breast cancer without evidence of disease recurrence or distant metastases.
- The participant must have undergone definitive surgery of the primary breast tumor(s).
- Participants must enroll in the study within 18 months of primary breast cancer surgery.
You will be excluded from the study if any of the following criteria apply to you:
- Participants with a history of any other cancer are excluded, unless in complete remission with no therapy for a minimum of 5 years from the date of randomization.
- Participant has breast cancer with any of the following features:
- Disease recurrence or distant metastatic disease (including contralateral axillary lymph nodes)
- Lymph node-negative status
- Pathological complete response (pCR) from any prior systemic treatments for early breast cancer
- Inflammatory breast cancer
This is a partial list of inclusion and exclusion criteria.