A Study Of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread (MONARCH 1)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
First received: March 31, 2014
Last updated: July 7, 2015
Last verified: July 2015
The main purpose of this study is to evaluate whether the study drug known as abemaciclib is effective in treating participants with breast cancer who have already tried other drug treatments.

Condition Intervention Phase
Metastatic Breast Cancer
Drug: Abemaciclib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study Of LY2835219 For Patients With Previously Treated Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer

Resource links provided by NLM:

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Objective Response Rate (ORR) [ Time Frame: Baseline up to approximately 14 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall Survival (OS) [ Time Frame: Baseline up to approximately 24 months ] [ Designated as safety issue: No ]
  • Duration of Response [ Time Frame: Baseline up to approximately 14 months ] [ Designated as safety issue: No ]
  • Progression Free Survival (PFS) [ Time Frame: Baseline up to approximately 14 months ] [ Designated as safety issue: No ]
  • Disease Control Rate (DCR) [ Time Frame: Baseline up to approximately 14 months ] [ Designated as safety issue: No ]
  • Clinical Benefit Rate (CBR) [ Time Frame: Baseline up to approximately 14 months ] [ Designated as safety issue: No ]
  • Change From Baseline in Brief Pain Inventory Short Form (mBPI-sf) [ Time Frame: Baseline up to approximately 14 months ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area Under the Concentration Curve (AUC) of Abemaciclib [ Time Frame: Baseline up to approximately 3 months ] [ Designated as safety issue: No ]
  • Change from Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) [ Time Frame: Baseline up to approximately 14 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 128
Study Start Date: June 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Abemaciclib
200 milligrams (mg) abemaciclib given orally once every 12 hours for 28 days (1 cycle). Participants may continue to receive treatment until discontinuation criteria are met
Drug: Abemaciclib
Administered orally
Other Name: LY2835219


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria.

  • Have a diagnosis of Hormone Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer.
  • Recurrent, locally advanced, unresectable or metastatic breast cancer with disease progression following anti-estrogen therapy.
  • Prior treatment with at least 2 chemotherapy regimens:

    • At least 1 of these regimens must have been administered in the metastatic setting.
    • At least 1 of these regimens must have contained a taxane.
    • No more than 2 prior chemotherapy regimens in the metastatic setting.
  • Have a performance status (PS) of 0 to 1 on the Eastern Cooperative Oncology Group scale.
  • Have discontinued all previous therapies for cancer.
  • Have the presence of measureable disease as defined by Response Evaluation Criteria in Solid Tumors Version 1.1.

Exclusion Criteria:

  • Have either a history of central nervous system (CNS) metastasis or evidence of CNS metastasis on the magnetic resonance image of brain obtained at baseline.
  • Received prior therapy with another CDK4/6 inhibitor.
  • Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug.
  • Have had major surgery within 14 days of the initial dose of study drug.
  • Have a history of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02102490

  Show 36 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
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

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02102490     History of Changes
Other Study ID Numbers: 15419, I3Y-MC-JPBN, 2013-005548-27
Study First Received: March 31, 2014
Last Updated: July 7, 2015
Health Authority: United States: Food and Drug Administration
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Belgium: Federal Agency for Medicines and Health Products, FAMHP
France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Eli Lilly and Company:
Endocrine Therapy, Taxane, MONARCH 1

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 24, 2015