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Randomized Phase II Trial of Letrozole With or Without Dasatinib as First and Second-line Treatment for Hormone Receptor-positive, HER2-negative Post-menopausal Breast Cancer That is Unresectable, Locally Recurrent or Metastatic

This study has been completed.
Sponsor:
Collaborator:
US Oncology Research
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00696072
First received: June 10, 2008
Last updated: May 10, 2016
Last verified: May 2016
Results First Received: March 9, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Metastatic Breast Cancer
Interventions: Drug: Dasatinib
Drug: Letrozole

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Study started October 2008 and completed June 2014; 23 participants chose to remain on active treatment after the study completed.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
120 participants were enrolled, randomized and treated.

Reporting Groups
  Description
Dasatinib Plus Letrozole

Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years

Dasatinib 100 mg + Letrozole 2.5 mg Tablets, once daily up to 2 years. If a participant experienced intolerable toxicity related to dasatinib, they had the option to crossover to letrozole arm.

Letrozole Participants received letrozole 2.5 mg tablets, once daily, up to 2 years. If the participant developed progressive disease while on the single agent, the participant had the option to add dasatinib to their treatment regimen.

Participant Flow:   Overall Study
    Dasatinib Plus Letrozole     Letrozole  
STARTED     57     63  
COMPLETED     0     0  
NOT COMPLETED     57     63  
continuing active treatment                 10                 13  
Adverse Event                 10                 6  
Patient Request                 3                 7  
Investigator Request                 1                 4  
Sponsor Request                 0                 1  
Disease Progression                 32                 30  
Non-specified                 1                 2  



  Baseline Characteristics
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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.
Intent to treat (ITT) population

Reporting Groups
  Description
Dasatinib Plus Letrozole

Dasatinib + Letrozole: Tablets, Oral, once daily, up to 2 years

Dasatinib 100 mg + Letrozole 2.5 mg

Letrozole Letrozole: Tablets, Oral, 2.5 mg, once daily, up to 2 years
Total Total of all reporting groups

Baseline Measures
    Dasatinib Plus Letrozole     Letrozole     Total  
Number of Participants  
[units: participants]
  57     63     120  
Age, Customized  
[units: participants]
     
Less than 65 years     33     34     67  
Greater than or equal to 65 years     24     29     53  
Gender  
[units: participants]
     
Female     57     63     120  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     57     63     120  



  Outcome Measures
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1.  Primary:   Number of Participants With Clinical Benefit (CBR) and Number of Participants With CBR Having a Disease Free Interval (DFI) Greater Than 2 Years - Evaluable Population   [ Time Frame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years) ]

2.  Secondary:   Number of Participants With Complete Response, Partial Response, Stable Disease, and Disease Progression   [ Time Frame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years) ]

3.  Secondary:   Median Progression Free Survival (PFS) - Intent to Treat (ITT) Population   [ Time Frame: Day 1 to Study Completion (approximately 6 years) ]

4.  Secondary:   Percentage of Participants Best Overall Response After Change From Letrozole to Letrozole Plus Dasatinib   [ Time Frame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years) ]

5.  Secondary:   Percentage of Participants With PFS At 6 Months and At 12 Months - ITT Population   [ Time Frame: At 6 months and at 12 months ]

6.  Secondary:   Median Time to Treatment Failure (TTF) - ITT Population   [ Time Frame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years) ]

7.  Secondary:   Number of Participants With Adverse Events (AEs) Leading to Discontinuation, Serious Adverse Events (SAEs), and Deaths   [ Time Frame: First dose of study drug to last dose plus 30 days, up to study completion (approximately 6 years) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com



Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00696072     History of Changes
Other Study ID Numbers: CA180-185
USOR 06-185
Study First Received: June 10, 2008
Results First Received: March 9, 2016
Last Updated: May 10, 2016
Health Authority: United States: Food and Drug Administration