Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Abemaciclib: Abemaciclib + NSAI or Fulvestrant Abemaciclib given orally and nonsteroidal aromatase inhibitor (NSAI) of physician’s choice (anastrazole or letrozole) given orally or Fulv
Sponsors
Eli Lilly and Company India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: • Have a diagnosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer • Have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease • Have postmenopausal status • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale • Have adequate organ function • Have discontinued previous cytotoxic therapies, biological agents, investigational agents, and radiotherapy • Are able to swallow oral formulation
Exclusion criteria
Exclusion criteria: • Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis. • Have clinical evidence or history of central nervous system metastasis. • Have received prior treatment with chemotherapy (except for neoadjuvant/adjuvant chemotherapy), fulvestrant, everolimus, or any cyclin-dependent kinase (CDK) 4 & 6 inhibitor. • Have received recent (within 28 days prior to study intervention) live vaccination (for example, yellow fever). Seasonal flu vaccinations that do not contain a live virus are permitted. • Have a personal history of presyncope or syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest. • Have inflammatory breast cancer or 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 3 years. • Have received an autologous or allogeneic stem-cell transplant • Have clinically relevant active bacterial or fungal infection, or detectable viral infection (for example, human immunodeficiency virus or viral hepatitis). Screening is not required for enrolment. • Are pregnant or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants Experiencing at Least One Treatment Emergent Adverse EventTimepoint: Baseline through Month 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Participants who Discontinue from Study Treatment Due to Adverse EventsTimepoint: Baseline through Month 6 | — |
Countries
India
Contacts
Public ContactDr Rajeev Sharan Shrivastava
Eli Lilly and Company (India) Pvt. Ltd.
Outcome results
None listed