Health Condition 1: null- Postmenopausal Women with Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer
Conditions
Interventions
Intervention1: Abemaciclib or Placebo: Abemaciclib or placebo will be supplied as capsules administered orally, 150 mg every 12 hours (Q12H) on Days 1 to 28 of a 28-day cycle.
Control Intervention1: N
Sponsors
Eli Lilly and Company
Eligibility
Inclusion criteria
Inclusion criteria: [1] have a diagnosis of HR+, HER2- breast cancer. Although not required as a protocol procedure, metastatic disease should be considered for biopsy whenever possible to reassess hormone receptor (HR) and human epidermal growth factor receptor 2 (HER2) status if clinically indicated. • To fulfill the requirement for HR+ disease, a breast cancer must express, by immunohistochemistry (IHC), at least 1 of the HRs (estrogen receptor [ER], progesterone receptor [PgR]) as defined in the relevant American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines (Hammond et al. 2010). • To fulfill the requirement of HER2- disease, a breast cancer must not demonstrate, at initial diagnosis or upon subsequent biopsy, overexpression of HER2 by either IHC or in-situ hybridization as defined in the relevant ASCO/CAP guidelines (Wolff et al. 2013). [2] meet either Inclusion Criterion (2a) or Inclusion Criterion (2b). Patients meeting Inclusion Criterion 2a will be enrolled in Cohort A and patients meeting Inclusion Criterion 2b will be enrolled in Cohort B. (2a) have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease • relapsed with radiologic evidence of progression more than 1 year from completion of adjuvant endocrine therapy and have received no prior endocrine therapy for locoregionally recurrent or metastatic disease (Note: prior adjuvant endocrine therapy for localized disease may have included, but is not limited to, anti-estrogens or aromatase inhibitors. In addition, a patient may be enrolled if she has received OR • presented de novo mBC and not received any prior endocrine therapy. (2b) have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease • relapsed with radiologic evidence of progression while receiving neoadjuvant or adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression OR • relapsed with radiologic evidence of progression within 1 year from completion of adjuvant endocrine therapy, with no subsequent endocrine therapy received following progression OR • relapsed with radiologic evidence of progression more than 1 year from completion of adjuvant endocrine therapy and then subsequently relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first- line endocrine therapy for metastatic disease. Patients may not have received more than 1 line of endocrine therapy or any prior chemotherapy for metastatic disease OR • presented de novo with metastatic disease and then relapsed with radiologic evidence of progression after receiving treatment with either an antiestrogen or an aromatase inhibitor as first-line endocrine therapy for metastatic disease. Patients may not have received more than 1 line of endocrine therapy or any prior chemotherapy for metastatic disease. [3] have postmenopausal status defined as meeting at least 1 of the following: • prior bilateral oophorectomy • age ï?³60 years • age
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival (PFS)Timepoint: Randomization to Measured Progressive Disease or Death (Estimated up to 38 Months) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Randomization in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30)Timepoint: Randomization, Follow-Up (Estimated up to 38 Months);Duration of Response (DoR)Timepoint: Date of CR or PR to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 38 Months);Overall Survival (OS)Timepoint: Randomization to Date of Death from Any Cause (Estimated up to 38 Months) ;Pharmacokinetics (PK): Area Under the Concentration Curve of Abemaciclib, its Metabolites, NSAI, and FulvestrantTimepoint: Post Dose Cycle 1 Day 1 through Pre-Dose Cycle 4 Day 1 (28 day cycles);Proportion of Participants who Exhibit Stable Disease (SD) or CR or PR [Disease Control Rate (DCR)]Timepoint: Randomization to Measured Progressive Disease (Estimated up to 38 Months);Proportion of Participants with Best Overall Response of Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]Timepoint: Randomization to Measured Progressive Disease (Estimated up to 38 Months);Proportion of Participants with Best Overall Response of CR, PR, or SD with Duration of SD for at Least 6 Months [Clinical Benefit Rate (CBR)]Timepoint: Randomization to Measured Progressive Disease (Estimated up to 38 Months) | — |
Countries
Brazil, China, India, South Africa
Contacts
Public ContactDr Rajeev Sharan Shrivastava
Eli Lilly and Company (India) Pvt. Ltd.
Outcome results
None listed