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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03988114
Recruitment Status : Withdrawn (Strategic decision due to emerging new data for patients with HR+, HER2- metastatic breast cancer.)
First Posted : June 17, 2019
Last Update Posted : September 6, 2019
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Abemaciclib Drug: Nonsteroidal Aromatase Inhibitor (NSAI) Phase 4

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Single-Arm, Global, Phase 4 Study of Abemaciclib, a CDK 4 & 6 Inhibitor, in Combination With Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) in Participants With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Advanced Breast Cancer With Poor Prognostic Factors
Estimated Study Start Date : September 16, 2019
Estimated Primary Completion Date : March 23, 2022
Estimated Study Completion Date : March 23, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Abemaciclib

Arm Intervention/treatment
Experimental: Abemaciclib + NSAI
Abemaciclib given orally and nonsteroidal aromatase inhibitor (NSAI) of physician's choice (anastrazole or letrozole) given orally.
Drug: Abemaciclib
Administered orally
Other Name: LY2835219

Drug: Nonsteroidal Aromatase Inhibitor (NSAI)
Letrozole administered orally or anastrozole administered orally (physician choice)

Primary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Baseline to Progressive Disease or Death from Any Cause (Estimated up to 26 Months) ]

  2. Objective Response Rate (ORR): Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [ Time Frame: Baseline to Objective Disease Progression (Estimated up to 26 Months) ]

Secondary Outcome Measures :
  1. Duration of Response (DoR) [ Time Frame: Date of CR or PR to Date of Objective Disease Progression or Death from Any Cause (Estimated up to 26 Months) ]

  2. Disease Control Rate (DCR): Percentage of Participants with a Best Overall Response of CR, PR, or Stable Disease (SD) [ Time Frame: Baseline to Objective Disease Progression (Estimated up to 26 Months) ]

  3. Clinical Benefit Rate (CBR): Proportion of Participants with Best Overall Response of CR, PR, or SD with Duration of SD for at Least 6 Months [ Time Frame: Date of CR, PR or SD to 6 Months Post CR, PR or SD (Estimated up to 26 Months) ]

  4. Time to Response (TTR) [ Time Frame: Baseline to Date of CR or PR (Estimated up to 26 Months) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03988114

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Sponsors and Collaborators
Eli Lilly and Company
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03988114    
Other Study ID Numbers: 17395
I3Y-MC-JPCX ( Other Identifier: Eli Lilly and Company )
2019-001781-16 ( EudraCT Number )
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://www.clinicalstudydatarequest.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs