Metastatic Breast Cancer
A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer (nextMONARCH 1)
The main purpose of this study is to evaluate the safety and efficacy of abemaciclib plus tamoxifen or abemaciclib alone in women with previously treated hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-), metastatic breast cancer.
The duration of your participation depends on how well your disease responds to the study treatment.
Key Participation Requirements
All clinical trials have rules about who can participate. This section outlines some of those rules. Please contact a study center to discuss the full set of criteria
- Participant must have a diagnosis of HR+, HER2- breast cancer
- Participant must have relapsed or progressed following endocrine therapy
- Participant must have received prior treatment with at least 2 chemotherapy regimens, of which at least 1 but no more than 2 have been administered in the metastatic setting
- Participant must have a negative serum pregnancy test within 7 days prior to randomization and agree to use medically approved precautions to prevent pregnancy during the study and for 12 weeks following last dose of study treatment
- Participant must be able to swallow oral medication
- Participant must not have active bacterial or fungal infection, or detectable viral infection
- Participant must not have received treatment with a prior cyclin-dependent kinase 4 (CDK4) and CDK 6 inhibitor
- Participant must not have a preexisting chronic condition resulting in persistent diarrhea
- Participant must not have a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix or breast), unless in complete remission with no therapy for a minimum of 3 years