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18F-FLT-PET in Breast Cancer (MK-0000-139)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01015131
First received: November 17, 2009
Last updated: August 11, 2014
Last verified: August 2014
Results First Received: November 6, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Breast Cancer
Intervention: Radiation: 18F-FLT-PET/CT Imaging

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After enrollment, 2 of the 46 participants discontinued due to lack of available 3'-deoxy-3'[18F]-fluorothymidine (18-FLT), leaving 44 participants as the baseline population.

Reporting Groups
  Description
All Participants Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy

Participant Flow:   Overall Study
    All Participants  
STARTED     44  
COMPLETED     36  
NOT COMPLETED     8  
Physician Decision                 1  
Protocol Violation                 1  
Withdrawal by Subject                 2  
Other Protocol Specified Criteria                 4  



  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.
No text entered.

Reporting Groups
  Description
All Participants Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  44  
Age  
[units: years]
Mean ± Standard Deviation
  50.0  ± 9.0  
Gender  
[units: participants]
 
Female     44  
Male     0  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in 18F-FLT-PET Mean Standardized Uptake Value (SUVmean) After the First Cycle of Standard of Care (SOC) Neo-adjuvant Chemotherapy.   [ Time Frame: Baseline and up to 3 weeks ]

2.  Primary:   Change From Baseline in 18F-FLT-PET Maximum Standardized Uptake Value (SUVmax) After the First Cycle of SOC Neo-adjuvant Chemotherapy.   [ Time Frame: Baseline and up to 3 weeks ]

3.  Primary:   Change From Baseline in Ki-67 Labeling Index After the First Cycle of SOC Neo-adjuvant Chemotherapy.   [ Time Frame: Baseline and up to 3 weeks ]

4.  Primary:   Spearman's Rank Correlation Coefficient Between Change From Baseline in Ki-67 Labeling Index and Change From Baseline in SUVmean After the First Cycle of SOC Neo-adjuvant Chemotherapy.   [ Time Frame: Baseline and up to 3 weeks ]

5.  Primary:   Spearman's Rank Correlation Coefficient Between Change From Baseline in Ki-67 Labeling Index and Change From Baseline in SUVmax After the First Cycle of SOC Neo-adjuvant Chemotherapy.   [ Time Frame: Baseline and up to 3 weeks ]

6.  Secondary:   Change From Baseline in Proliferation Signature Score (PSS) After the First Cycle of SOC Neo-adjuvant Chemotherapy.   [ Time Frame: Baseline and up to 3 weeks ]

7.  Secondary:   Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy.   [ Time Frame: Baseline and up to 30 weeks ]

8.  Secondary:   Spearman's Rank Correlation Coefficient Between Change From Baseline in PSS After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy.   [ Time Frame: Baseline and up to 30 weeks ]

9.  Secondary:   Spearman's Rank Correlation Coefficient Between Change From Baseline in Ki-67 LI After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy.   [ Time Frame: Baseline and up to 30 weeks ]

10.  Secondary:   Spearman's Rank Correlation Coefficient Between Change From Baseline in SUVmax After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy.   [ Time Frame: Baseline and up to 30 weeks ]

11.  Secondary:   Spearman's Rank Correlation Coefficient Between Change From Baseline in SUVmean After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy.   [ Time Frame: Baseline and up to 30 weeks ]


  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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01015131     History of Changes
Other Study ID Numbers: 0000-139, 2009_692
Study First Received: November 17, 2009
Results First Received: November 6, 2012
Last Updated: August 11, 2014
Health Authority: United States: Food and Drug Administration