I3Y-MC-JPCF
- Conditions
- Breast Cancer
- Registration Number
- JPRN-jRCT2080223612
- Lead Sponsor
- Eli Lilly Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 4580
The participant is 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 for 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% (for study cohort 2)
-The participant must be randomized within 12 weeks of completion of last non-endocrine treatment.
-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 8 weeks prior to randomization.
-Participants must have recovered from the acute effects of chemotherapy and radiotherapy and from surgical side effects following definitive breast surgery.
-Women regardless of menopausal status.
-Women of reproductive potential must have a negative serum 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.
-Stage IV (M1) disease (American Joint Committee on Cancer [AJCC] TNM Staging System for breast cancer - 7th edition).
-Stage IA disease (AJCC TNM Staging System for breast cancer - 7th edition).
-The participant has 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.
-Females who are pregnant or lactating.
-The participant has previously received treatment with any CDK4 and CDK6 inhibitor.
-The participant is receiving concurrent exogenous hormone therapy (for example, birth control pills or hormone replacement therapy).
-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.
-The participant has active bacterial infection, fungal infection, or detectable viral infection.
-The participant has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>To evaluate the efficacy, in terms of invasive disease-free survival (IDFS), as defined by the STEEP System, for patients with HR+, HER2- early stage breast cancer for abemaciclib 150 mg twice daily plus adjuvant endocrine therapy versus adjuvant endocrine therapy alone
- Secondary Outcome Measures
Name Time Method