Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer MedDRA version: 20.0 Level: PT Classification code 10006199 Term: Breast cancer stage I System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Female (regardless of menopausal status) or male =18 years of age •The patient has confirmed HR+, HER2-negative (HER2-), early stage resected invasive breast cancer without evidence of distant metastases. •The patient must have undergone definitive surgical of the primary beast tumor(s). •The patient must have tumor tissue from breast (preferred) or lymph node for exploratory biomarker analysis available prior to randomization. •The patient must have high risk of disease recurrence based on nodal status, tumor size, or grade regardless of Ki67 status (Cohort 1), or eligible exclusively based on a Ki67 status (Cohort 2) •The patient must be randomized within 16 months from the time of definitive breast cancer surgery •If the patient is currently receiving or initiating standard adjuvant endocrine therapy at time of study entry, she/he may receive up to 12 weeks of endocrine therapy until randomization following the last non-endocrine therapy (surgery, chemotherapy, or radiation), whichever is last. •Women of reproductive potential must have a negative blood pregnancy test and agree to use highly effective contraceptive methods •The patient has a ECOG performance status =1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2290 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2290
Exclusion criteria
Exclusion criteria: •The patient has metastatic disease (including controlateral axillary lymph nodes) or lymph node-negative breast cancer. Patients with inflammatory breast cancer are excluded. •Patients with a history of previous breast cancer are excluded, with the exception of ipsilateral DCIS treated by locoregional therapy alone =5 years ago. Patients with a history of contralateral DCIS treated by local regional therapy at any time may be eligible. Patients with a history of any other cancer (except nonmelanoma 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 patient has previously received treatment with any CDK4 and CDK6 inhibitor. •The patient is receiving concurrent exogenous reproductive hormone therapy (for example, birth control pills or hormone replacement therapy). •The patient has previously received endocrine therapy for breast cancer prevention (tamoxifen or raloxifene or aromatase inhibitors).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare invasive disease free survival (IDFS) for patients receiving adjuvant endocrine therapy plus abemaciclib treatment versus adjuvant endocrine therapy alone in HR+, HER2- breast cancer (Cohort 1 only);Secondary Objective: To evaluate the efficacy, in terms of IDFS, for patients with pretreatment Ki67 index =20% by central lab To evaluate the efficacy in terms of distant relapse-free survival (DRFS) and overall survival (OS) To assess the safety profile To evaluate the relationship between abemaciclib exposure and clinical (efficacy and safety) outcomes To evaluate health status, general oncology and breast cancer self-reported health related quality of life;Primary end point(s): To compare invasive disease free survival (IDFS) for patients receiving adjuvant endocrine therapy plus abemaciclib treatment versus adjuvant endocrine therapy alone in HR+, HER2- breast cancer (Cohort 1 only).;Timepoint(s) of evaluation of this end point: After approximately 5 years when approximately 390 events have occured. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Invasive disease-free survival (IDFS) for patients with HR+, HER- early stage breast cancer with pretreatment Ki67 index = 20% (both Cohort 1 and Cohort 2 by central lab) •Efficacy endpoints: distant relapse-free survival (DRFS), overall survival (OS) •Safety endpoints will include but are not limited to the following: TEAEs, SAEs, and hospitalizations Clinical laboratory tests, vital signs, and physical examinations •Steady-state trough abemaciclib concentration (Cmin,ss), hazard ratio for IDFS, DRFS, OS, other efficacy and safety endpoints •Composite and single-item endpoints will be evaluated to examine differentiating effects of abemaciclib across study arms. Measurement will be undertaken using the FACT-B questionnaire for general oncology and breast cancer health-related quality of life; the FACT-ES subscale and additional FACIT-sourced items for cognitive and bladder endocrine therapy symptoms; and the FACIT-F subscale to characterize this symptom know to be associated with oncology, endocrine therapy, and abemaciclib treatment. •The EQ-5D-5L health state profile (the index score and the single-item health status measure) will be used to inform decision modeling for economic evaluations and this questionnaire will be coadministered with and after first completing the FACT/FACIT questionnaire, subscales, and additional items. ;Timepoint(s) of evaluation of this end point: After approximately 5 years when approximately 390 events have occured. At the end of trial. | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, New Zealand, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed