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A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer (MONARCH 3)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02246621
First Posted: September 23, 2014
Last Update Posted: June 15, 2017
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.
Information provided by (Responsible Party):
Eli Lilly and Company
  Purpose
The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors (NSAI) plus abemaciclib are in postmenopausal women with breast cancer. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio.

Condition Intervention Phase
Breast Cancer Drug: Abemaciclib Drug: Anastrozole Drug: Letrozole Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Nonsteroidal Aromatase Inhibitors (Anastrozole or Letrozole) Plus LY2835219, a CDK4/6 Inhibitor, or Placebo in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer With No Prior Systemic Therapy in This Disease Setting

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Baseline up to Measured Progressive Disease or Death from Any Cause (Approximately 34 Months) ]

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Baseline to Date of Death from Any Cause (Approximately 82 Months) ]
  • Duration of Response (DoR) [ Time Frame: Date of Complete Response (CR) or Partial Response (PR) to Date of Objective Disease Progression or Death Due to Any Cause (Estimated up to 34 Months) ]
  • Disease Control Rate (DCR) [ Time Frame: Baseline to Disease Progression (Approximately 34 Months) ]
  • Clinical Benefit Rate (CBR) [ Time Frame: Baseline to Disease Progression (Approximately 34 Months) ]
  • Change from Baseline to End of Study in Symptom Burden on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) [ Time Frame: Baseline, End of Study (up to 34 Months) ]
  • Change from Baseline to End of Study in Symptom Burden on the EORTC QLQ-Breast23 Questionnaire [ Time Frame: Baseline, End of Study (up to 34 Months) ]
  • Change from Baseline to End of Study in Health Status on the EuroQuol 5-Dimension 5 Level (EuroQol-5D 5L) [ Time Frame: Baseline, End of Study (up to 34 Months) ]
  • Pharmacokinetics (PK): Volume of Distribution of Abemaciclib, its Metabolites, and NSAI Therapy [ Time Frame: Cycle 1 Postdose through Cycle 4 (Approximately 4 Months) ]
  • Objective Response Rate (ORR) [ Time Frame: Baseline to Disease Progression (Approximately 34 Months) ]
  • PK: Clearance of Abemaciclib, its Metabolites, and NSAI Therapy [ Time Frame: Cyle 1 Postdose through Cycle 4 (Approximately 4 Months) ]

Estimated Enrollment: 450
Study Start Date: November 2014
Estimated Study Completion Date: July 2021
Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Abemaciclib + NSAI
150 milligrams (mg) Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Drug: Abemaciclib
Administered orally
Other Name: LY2835219
Drug: Anastrozole
Administered orally
Drug: Letrozole
Administered orally
Placebo Comparator: Placebo + NSAI
Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).
Drug: Anastrozole
Administered orally
Drug: Letrozole
Administered orally
Drug: Placebo
Administered orally

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a diagnosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer
  • Have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease
  • Have postmenopausal status
  • Have either measurable disease or nonmeasurable bone-only disease
  • Have a performance status ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale
  • Have adequate organ function
  • Have discontinued previous localized radiotherapy for palliative purposes or for lytic lesions at risk of fracture prior to randomization and recovered from the acute effects of therapy
  • Are able to swallow capsules

Exclusion Criteria:

  • Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis
  • Have inflammatory breast cancer
  • Have clinical evidence or a history of central nervous system (CNS) metastasis
  • Are currently receiving or have previously received endocrine therapy for locoregionally recurrent or metastatic breast cancer
  • Have received prior (neo)adjuvant endocrine therapy with a disease-free interval ≤12 months from completion of treatment
  • Are currently receiving or have previously received chemotherapy for locoregionally recurrent or metastatic breast cancer
  • Have received prior treatment with everolimus
  • Have received prior treatment with any cyclin-dependent kinase (CDK) 4/6 inhibitor (or participated in any CDK4/6 inhibitor clinical trial for which treatment assignment is still blinded)
  • Have initiated bisphosphonates or approved receptor activator of nuclear factor kappa-B ligand (RANK-L) targeted agents <7 days prior to randomization
  • Are currently receiving an investigational drug in a clinical trial or participating in any other type of medical research judged not to be scientifically or medically compatible with this study
  • Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of randomization for a nonmyelosuppressive or myelosuppressive agent, respectively
  • Have had major surgery within 14 days prior to randomization
  Contacts and Locations
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): NCT02246621


  Show 167 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02246621     History of Changes
Other Study ID Numbers: 15417
I3Y-MC-JPBM ( Other Identifier: Eli Lilly and Company )
2014-001502-18 ( EudraCT Number )
First Submitted: September 18, 2014
First Posted: September 23, 2014
Last Update Posted: June 15, 2017
Last Verified: June 2017

Keywords provided by Eli Lilly and Company:
MONARCH 3

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Anastrozole
Aromatase Inhibitors
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal