A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer (proMONARCH)

Lilly

Status and phase: Withdrawn; Phase 4

Conditions: Metastatic Breast Cancer

Treatments: Drug: Nonsteroidal Aromatase Inhibitor (NSAI); Drug: Abemaciclib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03988114

I3Y-MC-JPCX (Other Identifier)

2019-001781-16 (EudraCT Number)

17395

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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:

  • A high grade tumor in tissue
  • Negative progesterone receptor (PR) status
  • Have cancer that has spread to the liver
  • Have a treatment-free interval (TFI) <36 months

• Participants must have HR+, HER2- breast cancer

• Participants must have adequate organ function

Exclusion criteria

• Participants must not have cancer that has spread to other organs that has severely affected their function
• Participants must not have cancer that has spread to the brain that is unstable or untreated
• Participants must not have received endocrine therapy in the metastatic setting
• Participants must not have known active infection
• Participants must not have received prior endocrine therapy and had disease return within 12 months from completion of treatment
• Participants must not have received prior treatment with any cyclin-dependent kinase (CDK) 4 & 6 inhibitor or everolimus

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Abemaciclib + NSAI

Experimental group

Description:

Abemaciclib given orally and nonsteroidal aromatase inhibitor (NSAI) of physician's choice (anastrazole or letrozole) given orally.

Treatment:

Drug: Abemaciclib

Drug: Nonsteroidal Aromatase Inhibitor (NSAI)