A Study of Abemaciclib in Indian Women With Advanced Breast Cancer

This is an interventional treatment trial for Breast Neoplasms Read More

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:

• 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.