Study Condition(s): Metastatic Breast Cancer, Breast Cancer

A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer (monarcHER)

Study Alias: JPBZ

Study Identifier(s): Tool Tip Icon {{ defaultRegistry.registryAnchorText }} NCT02675231 {{ currentLocaleObject.registryAnchorText }}

Study Purpose

The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant or chemotherapy in women with HR+, HER2+ locally advanced or metastatic breast cancer after prior exposure to at least two HER2-directed therapies for advanced disease.

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 and how many cycles of treatment you receive.
  • Participant must have a diagnosis of HR+, HER2+ advanced breast cancer

  • Participant must have unresectable, locally advanced, recurrent breast cancer or metastatic breast cancer

  • Participant must provide adequate tumor tissue prior to participation

  • Participant must have previously received at least two HER2-directed therapies for advanced disease

  • Participant must have received a taxane and trastuzumab emtansine (T-DM1) in any disease setting

  • Participant must have received any endocrine therapy (excluding fulvestrant)

  • Participant must have postmenopausal status

  • Participant must not have received prior treatment with any cyclin-dependent kinase (CDK) 4 and CDK 6 inhibitor

  • Participant must not have had symptomatic congestive heart failure, heart attack, or unstable angina within the last 6 months

  • Participant must not have known central nervous system (CNS) metastases that are untreated, symptomatic, or require steroids to control symptoms

Where to Participate

88 locations are currently available of 92 planned
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