A Study of Abemaciclib in Indian Women With Advanced Breast Cancer
Condition: Breast Neoplasms; Neoplasm Metastasis
MeSH terms: Neoplasms; Neoplasm Metastasis; Breast Neoplasms
Intervention: Abemaciclib; Nonsteroidal Aromatase Inhibitor (NSAI); Fulvestrant
Intervention description: Administered orally; Letrozole or anastrozole administered orally (physician choice); Administered intramuscularly
Intervention MeSH terms: Fulvestrant; Aromatase Inhibitors
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 200.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to learn more about the safety and tolerability of
      abemaciclib when given in combination with hormone therapy in Indian women with advanced
      breast cancer. Participants must have hormone receptor positive (HR+), human epidermal growth
      factor receptor 2 negative (HER2-) breast cancer and must live in India. For each
      participant, the study could last up to eight months and may include up to eight visits to
      the study center.
    

Eligibility 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:

          -  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.