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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02102490
Other study ID # 15419
Secondary ID I3Y-MC-JPBN2013-
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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).

Study Design


Related Conditions & MeSH terms


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
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