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A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer (MONARCH 2)

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ClinicalTrials.gov Identifier: NCT02107703
Recruitment Status : Active, not recruiting
First Posted : April 8, 2014
Results First Posted : March 13, 2018
Last Update Posted : August 9, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Breast Neoplasms
Interventions: Drug: Abemaciclib
Drug: Fulvestrant
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In the Participant Flow, participants who completed were those who died due to any cause or were alive and on study at conclusion but off treatment.

Reporting Groups
  Description
Abemaciclib + Fulvestrant 150 milligrams (mg) Abemaciclib given orally once every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
Placebo + Fulvestrant Placebo supplied as capsules administered orally every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.

Participant Flow:   Overall Study
    Abemaciclib + Fulvestrant   Placebo + Fulvestrant
STARTED   446   223 
Received at Least 1 Dose of Study Drug   441   223 
COMPLETED   85   48 
NOT COMPLETED   361   175 
Withdrawal by Subject                36                19 
Lost to Follow-up                6                4 
On study treatment/follow up                319                152 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants.

Reporting Groups
  Description
Abemaciclib + Fulvestrant 150 mg Abemaciclib given orally once every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
Placebo + Fulvestrant Placebo supplied as capsules administered orally every 12 hours in 28 day cycles. 500 mg fulvestrant administered as two 250-mg injections IM on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond. Participants may continue to receive treatment until discontinuation criteria are met.
Total Total of all reporting groups

Baseline Measures
   Abemaciclib + Fulvestrant   Placebo + Fulvestrant   Total 
Overall Participants Analyzed 
[Units: Participants]
 446   223   669 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed   446   223   669 
   59.3  (11.2)   61.1  (11.7)   59.9  (11.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Participants Analyzed   446   223   669 
Female   446   223   669 
Male   0   0   0 
Ethnicity (NIH/OMB) [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed   443   223   666 
Hispanic or Latino   57   25   82 
Not Hispanic or Latino   303   162   465 
Unknown or Not Reported   83   36   119 
[1] All randomized participants who had baseline Ethnicity data.
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Participants Analyzed   446   223   669 
American Indian or Alaska Native   18   8   26 
Asian   149   65   214 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   9   5   14 
White   237   136   373 
More than one race   0   0   0 
Unknown or Not Reported   33   9   42 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
North America       
Participants Analyzed   446   223   669 
North America   120   58   178 
Europe       
Participants Analyzed   446   223   669 
Europe   179   100   279 
Taiwan       
Participants Analyzed   446   223   669 
Taiwan   25   14   39 
Japan       
Participants Analyzed   446   223   669 
Japan   64   31   95 
South Korea       
Participants Analyzed   446   223   669 
South Korea   58   20   78 


  Outcome Measures

1.  Primary:   Progression-Free Survival (PFS)   [ Time Frame: From Date of Randomization until Disease Progression or Death Due to Any Cause (Up To 31 Months) ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: From Date of Randomization until Death Due to Any Cause (Up To 80 Months) ]

3.  Secondary:   Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) (Objective Response Rate [ORR])   [ Time Frame: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months) ]

4.  Secondary:   Duration of Response (DOR)   [ Time Frame: From Date of CR, PR until Disease Progression or Death Due to Any Cause (Up To 31 Months) ]

5.  Secondary:   Percentage of Participants Achieving CR, PR or Stable Disease (SD) (Disease Control Rate [DCR])   [ Time Frame: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months) ]

6.  Secondary:   Percentage of Participants With CR, PR or SD With a Duration of At Least 6 Months (Clinical Benefit Rate [CBR])   [ Time Frame: From Date of First Dose until Disease Progression or Death Due to Any Cause (Up To 31 Months) ]

7.  Secondary:   Change From Baseline in Pain and Symptom Burden Assessment Using the Modified Brief Pain Inventory-Short Form (mBPI-sf)   [ Time Frame: Baseline, End of Study (Up To 31 Months) ]

8.  Secondary:   Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of Abemaciclib, Its Metabolites M2 and M20   [ Time Frame: Cycle 1 Day 1 2-4 hours (h) post dose, Cycle 1 Day 15 4 and 7h post dose, Cycle 2 Day 1 pre dose and 3h post dose, Cycle 3 Day1 pre dose ]

9.  Secondary:   Change From Baseline in Health Status Using the EuroQol 5-Dimension 5 Level (EQ-5D 5L)   [ Time Frame: Baseline, End of Study (Up To 31 Months) ]

10.  Secondary:   Change From Baseline to Short Term Follow up in Quality of Life Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)   [ Time Frame: Baseline, Short Term Follow Up (Up To 31 Months) ]

11.  Secondary:   Change From Baseline to Short Term Follow up in Quality of Life Using the EORTC QLQ-BR23 (Breast) Questionnaire   [ Time Frame: Baseline, Short Term Follow Up (Up To 31 Months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979
e-mail: ClinicalTrials.gov@lilly.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02107703     History of Changes
Other Study ID Numbers: 15362
I3Y-MC-JPBL ( Other Identifier: Eli Lilly and Company )
2013-004728-13 ( EudraCT Number )
First Submitted: April 4, 2014
First Posted: April 8, 2014
Results First Submitted: February 12, 2018
Results First Posted: March 13, 2018
Last Update Posted: August 9, 2018