Study Condition(s): Breast Cancer

A Study of Abemaciclib (LY2835219) in Combination With Other Therapies in Participants With Breast Cancer That Has Spread

Study Alias: JPBH

Study Identifier(s): Tool Tip Icon {{ defaultRegistry.registryAnchorText }} NCT02057133 {{ currentLocaleObject.registryAnchorText }}

Study Purpose

The main purpose of this study is to evaluate the safety of a study drug known as Abemaciclib (LY2835219) in combination with different therapies (letrozole, anastrozole, tamoxifen, exemestane, exemestane plus everolimus, trastuzumab, or LY3023414 plus fulvestrant) for breast cancer that has spread to other parts of the body.

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

Your participation could last up to 4 years depending on how you and your tumor respond.
  • Participant in Parts A-E and G must have a diagnosis of hormone receptor positive (HR+), human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancer; Participant in Part F must have a diagnosis of HER2 positive metastatic breast cancer
  • Participant in Part A (LY2835219 + letrozole) must not have received prior systemic endocrine therapy for metastatic disease,eExcept for ongoing therapy with letrozole
  • Participant in Part B (LY2835219 + anastrozole) must not have received prior systemic endocrine therapy for metastatic disease, except for ongoing therapy with anastrozole
  • Participant in Part C (LY2835219 + tamoxifen) may have received prior systemic endocrine therapy for metastatic disease and may be receiving ongoing therapy with tamoxifen
  • Participant in Part D (LY2835219 + exemestane) must have received prior systemic endocrine therapy with at least one nonsteroidal aromatase inhibitor (anastrozole, letrozole) for metastatic disease and may be receiving ongoing therapy with exemestane
  • Participant in Part E (LY2835219 + exemestane + everolimus) must have received prior systemic endocrine therapy with at least one nonsteroidal aromatase inhibitor (anastrozole, letrozole) for metastatic disease and may be receiving ongoing therapy with either exemestane or exemestane + everolimus
  • Participant in Part F (LY2835219 + trastuzumab) must have received at least 1 chemotherapy regimen for metastatic disease and may be receiving ongoing therapy with trastuzumab
  • Participant in Part F must have an estimated left ventricular ejection fraction within the normal range by either echocardiogram or multigated acquisition (MUGA) scan
  • Participant in Part G (abemaciclib + LY3023414 + fulvestrant) may have received prior systemic endocrine therapy with at least one nonsteroidal aromatase inhibitor (anastrozole, letrozole) for metastatic disease
  • Participant in Part G must not have type 1 diabetes mellitus or a history of gestational diabetes mellitus. Participants with a type 2 diabetes mellitus are eligible if adequate control of blood glucose level is obtained with oral therapy as documented by Hemoglobin A1c <7%

Where to Participate

15 locations are currently available of 15 planned
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