A Single-Arm, Global, Phase 4 Study of Abemaciclib, a CDK 4 & 6 Inhibitor, in Combination With Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) in Participants With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced Breast Cancer With Poor Prognostic Factors
A Single-Arm, Global, Phase 4 Study of Abemaciclib, a CDK 4 & 6 Inhibitor, in Combination With Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) in Participants With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced Breast Cancer With Poor Prognostic Factors
The reason for this study is to see if the drug abemaciclib in combination with nonsteroidal aromatase inhibitors (anastrozole or letrozole) is effective in participants with Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) advanced breast cancer that have certain disease characteristics.
Inclusion Criteria:
Participants must have completed (neo) adjuvant endocrine therapy and have cancer return after at least 12 months or have de novo cancer that has spread to other organs at diagnosis
Participants must have 1 or more of the following:
Participants must have HR+, HER2- breast cancer
Participants must have adequate organ function
Exclusion Criteria:
CABA, Buenos Aires C1440CFD, Argentina
CABA, Ciudad Autonoma Buenos Aires C1125ABD, Argentina
Ciudad Autonoma Buenos Aires, C1430EGF, Argentina
Tucumain, 4000, Argentina
Haine-St.- Paul, 7100, Belgium
Sao Jose Rio Preto, São Paulo 15090-000, Brazil