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

Metastatic Breast Cancer Clinical Trial

— MONARCH 1  

Official title:

A Phase 2 Study of LY2835219 for Patients With Previously Treated Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02102490
• Other study ID #: 15419
• Secondary ID: I3Y-MC-JPBN2013-
• Status: Completed
• Phase: Phase 2
• Start date: June 10, 2014
• Est. completion date: October 22, 2018

Study information

• Verified date: January 2020
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: October 22, 2018
• Est. primary completion date: April 30, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 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).

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• Abemaciclib
Administered orally

Locations

Country	Name	City	State
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.	Brussel
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
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
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
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.	Dijon
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
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.	Barcelona
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
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
United States	Texas Oncology Cancer Center	Austin	Texas
United States	Texas Oncology - Bedford	Bedford	Texas
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Oncology Hematology Care Inc	Cincinnati	Ohio
United States	Maryland Oncology Hematology, P.A.	Columbia	Maryland
United States	Presbyterian Hospital Dallas	Dallas	Texas
United States	Texas Oncology-Baylor Charles A. Sammons Cancer Center	Dallas	Texas
United States	Rocky Mountain Cancer Center	Denver	Colorado
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	The Center for Cancer and Blood Disorders	Fort Worth	Texas
United States	Texas Oncology-Memorial City	Houston	Texas
United States	Advanced Medical Specialties	Miami	Florida
United States	Minnesota Oncology/Hematology PA	Minneapolis	Minnesota
United States	Sarah Cannon Research Institute SCRI	Nashville	Tennessee
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Texas Oncology-Plano West	Plano	Texas
United States	Florida Cancer Specialists	Saint Petersburg	Florida
United States	Univ of California San Francisco	San Francisco	California
United States	Sansum Medical Research Foundation	Santa Barbara	California
United States	Northern Arizona Hematology & Oncology Associates	Sedona	Arizona
United States	Texas Oncology-Sherman	Sherman	Texas
United States	US Oncology	The Woodlands	Texas
United States	Arizona Clinical Research Center	Tucson	Arizona
United States	HOPE Hematology Oncology Physicians and Extenders	Tucson	Arizona
United States	Tyler Cancer Center	Tyler	Texas
United States	Northwest Cancer Specialists PC	Vancouver	Washington
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Belgium,  France,  Spain, 

References & Publications (1)

Dickler MN, Tolaney SM, Rugo HS, Cortés J, Diéras 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 Patie — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Survival (OS)	OS defined as the time from first dose date to the date of death due to any cause. For each participant who is not known to have died as of the data-inclusion cutoff date for overall survival analysis, OS time was censored on the last date the participant is known to be alive.	From Date of First Dose until Death Due to Any Cause (Up To 27 Months)
Secondary	Duration of Response (DOR)	DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the 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 LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date.	From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 14 Months)
Secondary	Progression Free Survival (PFS)	PFS defined as the time from the first day of therapy to the first evidence of disease progression as defined by RECIST v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of first dose, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.	From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 27 Months)
Secondary	Percentage of Participants With CR, PR or SD (Disease Control Rate [DCR])	Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. 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 LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, 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	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)	Clinical benefit rate defined as percentage of patients with best overall response of CR, PR, or SD with a duration of at least 6 months. CR, PR, or SD were defined using RECIST, v1.1 criteria. 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 LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. Percentage of participants = (participants with CR+PR+SD with a duration of at least 6 months /number of participants enrolled) *100.	From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 14 Months)
Secondary	Number of Participants With Categorical Change From Baseline in Brief Pain Inventory Short Form (mBPI-sf) - Worst Pain Score	A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24 hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine).	Cycle 6 Day 1
Secondary	Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-8]) for Abemaciclib and Metabolites M2 and M20	Area Under the Concentration versus Time Curve from Time Zero to Infinity (AUC[0-8]) was evaluated for Abemaciclib and Metabolites M2 and M20	Cycle 1 Day 1 pre dose, Cycle 1 Day 15 4 hours (h) and 7 h post dose, Cycle 2 Day 1 pre dose and 3 h post dose, Cycle 3 Day1 pre dose
Secondary	Number of Participants With Categorical Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) - Global Health Status Score	EORTC QLQ-C30 v3.0 was a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For functional domains and global health status, higher scores represent a better level of functioning. For symptoms scales, higher scores represented a greater degree of symptoms.	Cycle 6 Day 1