A Study of Abemaciclib (LY2835219) In Participants With Previously Treated Breast Cancer That Has Spread
MONARCH 1
A Phase 2 Study of LY2835219 for Patients With Previously Treated Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
3 other identifiers
interventional
132
4 countries
36
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2014
Typical duration for phase_2
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2014
CompletedFirst Posted
Study publicly available on registry
April 3, 2014
CompletedStudy Start
First participant enrolled
June 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2016
CompletedResults Posted
Study results publicly available
November 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 22, 2018
CompletedJanuary 21, 2020
January 1, 2020
1.9 years
March 31, 2014
October 27, 2017
January 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])
ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions.
From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
Secondary Outcomes (8)
Overall Survival (OS)
From Date of First Dose until Death Due to Any Cause (Up To 27 Months)
Duration of Response (DOR)
From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 14 Months)
Progression Free Survival (PFS)
From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 27 Months)
Percentage of Participants With CR, PR or SD (Disease Control Rate [DCR])
From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
Percentage of Participants With Tumor Response of Stable Disease (SD) for at Least 6 Months, Partial Response (PR) or Complete Response (CR) (Clinical Benefit Rate)
From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
- +3 more secondary outcomes
Study Arms (1)
Abemaciclib
EXPERIMENTAL200 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 cyclin-dependent kinases 4 and 6 (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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
Northern Arizona Hematology & Oncology Associates
Sedona, Arizona, 86336, United States
HOPE Hematology Oncology Physicians and Extenders
Tucson, Arizona, 85704, United States
Arizona Clinical Research Center
Tucson, Arizona, 85715, United States
Univ of California San Francisco
San Francisco, California, 94115, United States
Sansum Medical Research Foundation
Santa Barbara, California, 93105, United States
Rocky Mountain Cancer Center
Denver, Colorado, 80220, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Florida Cancer Specialists
Fort Myers, Florida, 33916, United States
Advanced Medical Specialties
Miami, Florida, 33176, United States
Florida Cancer Specialists
St. Petersburg, Florida, 33705, United States
Maryland Oncology Hematology, P.A.
Columbia, Maryland, 21044, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
Minnesota Oncology/Hematology PA
Minneapolis, Minnesota, 55404, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Oncology Hematology Care Inc
Cincinnati, Ohio, 45242, United States
Sarah Cannon Research Institute SCRI
Nashville, Tennessee, 37203, United States
Texas Oncology Cancer Center
Austin, Texas, 78731, United States
Texas Oncology - Bedford
Bedford, Texas, 76022, United States
Presbyterian Hospital Dallas
Dallas, Texas, 75231, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
The Center for Cancer and Blood Disorders
Fort Worth, Texas, 76104, United States
Texas Oncology-Memorial City
Houston, Texas, 77024, United States
Texas Oncology-Plano West
Plano, Texas, 75093, United States
Texas Oncology-Sherman
Sherman, Texas, 75090-0504, United States
US Oncology
The Woodlands, Texas, 77380, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
Northwest Cancer Specialists PC
Vancouver, Washington, 98684, United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Brussels, 1000, Belgium
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Charleroi, 6000, Belgium
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Leuven, 3000, Belgium
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Liège, 4000, Belgium
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Dijon, 21034, France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Paris, 75248, France
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Barcelona, 08035, Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Madrid, 28007, Spain
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Valencia, 46015, Spain
Related Publications (1)
Dickler MN, Tolaney SM, Rugo HS, Cortes J, Dieras V, Patt D, Wildiers H, Hudis CA, O'Shaughnessy J, Zamora E, Yardley DA, Frenzel M, Koustenis A, Baselga J. MONARCH 1, A Phase II Study of Abemaciclib, a CDK4 and CDK6 Inhibitor, as a Single Agent, in Patients with Refractory HR+/HER2- Metastatic Breast Cancer. Clin Cancer Res. 2017 Sep 1;23(17):5218-5224. doi: 10.1158/1078-0432.CCR-17-0754. Epub 2017 May 22.
PMID: 28533223RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
March 31, 2014
First Posted
April 3, 2014
Study Start
June 10, 2014
Primary Completion
April 30, 2016
Study Completion
October 22, 2018
Last Updated
January 21, 2020
Results First Posted
November 30, 2017
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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.
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.