Study Condition(s): Metastatic Breast Cancer

A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer (nextMONARCH 1)

Study Alias: JPCG

Study Identifier(s): Tool Tip Icon {{ defaultRegistry.registryAnchorText }} NCT02747004 {{ currentLocaleObject.registryAnchorText }}

Study Purpose

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.

Key Participation Requirements Tool Tip Icon

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

Gender

Female

Age

18+ years

Time Commitment

The duration of your participation depends on how well your disease responds to the study treatment.
  • 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

Where to Participate

58 locations are currently available of 72 planned
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