Breast Cancer
Conditions
Interventions
investigational material(s)
Generic name etc : Abemaciclib plus Standard Adjuvant Endocrine Therapy
INN of investigational material : Abemaciclib
Therapeutic category code : 429 Other antitumor agents
Sponsors
Eli Lilly Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -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.
Exclusion criteria
Exclusion criteria: -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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy 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
| Measure | Time frame |
|---|---|
| safety efficacy confirmatory pharmacokinetics other 1.IDFS for Participants with Ki-67 Index greater than or equal to 20% [ Time Frame: Baseline to Recurrence or Death from Any Cause (Approximately 10 Years) ] IDFS for participants with Ki-67 index greater than or equal to 20% 2.Distant Relapse-Free Survival (DRFS) [ Time Frame: Baseline to Distant Recurrence or Death from Any Cause (Approximately 10 Years) ] DRFS 3.Overall Survival (OS) [ Time Frame: Baseline to Death from Any Cause (Approximately 10 Years) ] OS 4.Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib [ Time Frame: Post Dose Day 1 through Month 3 ] PK: Cmin,ss of Abemaciclib 5.Change from Baseline on the Functional Assessment of Cancer Therapy - Breast (FACT-B) [ Time Frame: Baseline, Follow Up (Approximately 3 Years) ] Change from Baseline on the FACT-B 6.Change from Baseline on the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) [ Time Frame: Baseline, Follow Up (Approximately 3 Years) ] Change from Baseline on the FACT-ES 7.Change from Baseline on the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) [ Time Frame: Baseline, Follow Up (Approximately 3 Years) ] Change from Baseline on the FACIT-F 8.Change from Baseline on the EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L) [ Time Frame: Baseline, Follow Up (Approximately 3 Years) ] Change from Baseline on the EQ-5D-5L | — |
Countries
Africa, Asia except Japan, Europe, Japan, North America, Oceania, South America
Outcome results
None listed