Phase II Study of Fluorine-18 3'-Deoxy-3'-Fluorothymidine (F-18-FLT) in Invasive Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00572728
First received: December 11, 2007
Last updated: December 10, 2015
Last verified: August 2014
Results First Received: March 18, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Stage IIB Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Interventions: Procedure: CT
Drug: 18F-FLT
Procedure: PET

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Diagnostic (18F-FLT)

Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.

Fluorothymidine F-18: Undergo 18F-FLT PET/CT

Positron Emission Tomography: Undergo 18F-FLT PET/CT

Computed Tomography: Undergo 18F-FLT PET/CT

Laboratory Biomarker Analysis: Correlative studies


Participant Flow:   Overall Study
    Diagnostic (18F-FLT)  
STARTED     90 [1]
Eligible     87  
Enrolled Under Amendment 5 or Later     82  
Did Not Withdraw     72  
On Study     71  
Completed FLT1 Scan     67  
First Therapy Initiated     65  
Completed FLT2 Scan     60  
Second Chemotherapy Initiated     59  
Second Chemotherapy Initiated After FLT2     52  
Pathology Complete     51  
Completed FLT3 Scan     43 [2]
LN Evaluation After NAC     38 [3]
RCB Evaluation     35 [4]
COMPLETED     51 [5]
NOT COMPLETED     39  
Withdrawal by Subject                 10  
Ineligible                 3  
Enrolled under Amendment 4                 5  
Offstudy due to complicating disease                 1  
FLT1 not completed                 4  
First Chemotherapy not initiated                 2  
FLT2 not completed                 5  
Second chemotherapy not initiated                 1  
FLT2 after second chemotherapy initiated                 7  
Pathology missing                 1  
[1] Registered
[2] Secondary analysis milestone: 43 pts had FLT-3 performed.
[3] Secondary:38 patients were available for histopathological LN evaluation after NAC
[4] Secondary: histopathology was available in 35 patients for RCB evaluation
[5] 51 patients eligible for primary objective analysis



  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.
Registered

Reporting Groups
  Description
Diagnostic (18F-FLT)

Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.

Fluorothymidine F-18: Undergo 18F-FLT PET/CT

Positron Emission Tomography: Undergo 18F-FLT PET/CT

Computed Tomography: Undergo 18F-FLT PET/CT

Laboratory Biomarker Analysis: Correlative studies


Baseline Measures
    Diagnostic (18F-FLT)  
Number of Participants  
[units: participants]
  90  
Age  
[units: years]
Mean (Full Range)
  51  
  (22 to 83)  
Gender [1]
[units: participants]
 
Female     90  
Male     0  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     9  
Not Hispanic or Latino     75  
Unknown or Not Reported     6  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     1  
Asian     2  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     25  
White     51  
More than one race     0  
Unknown or Not Reported     11  
Region of Enrollment  
[units: participants]
 
United States     90  
[1] Overall Number of Baseline Participants



  Outcome Measures
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1.  Primary:   %Change in FLT Uptake Between the Baseline (Pre-therapy) and the Early-therapy Imaging Studies to Predict Pathological Complete Response   [ Time Frame: Baseline (FLT-1) to early therapy (5-10 days after chemotherapy, FLT-2) ]

2.  Secondary:   Correlation Between SUVmax and Ki‐67 LI at FLT1(Baseline PET)   [ Time Frame: Baseline (FLT-1) ]

3.  Secondary:   Correlation Between SUVmax and Ki‐67 LI at FLT3 (Post-NAC)   [ Time Frame: Post-NAC (FLT3) ]

4.  Secondary:   SUVmax at FLT-1 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III   [ Time Frame: Baseline (FLT-1) ]

5.  Secondary:   SUVmax at FLT-2 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III   [ Time Frame: early treatment (FLT2) ]

6.  Secondary:   SUVmax at FLT-3 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III   [ Time Frame: post-NAC (FLT-3) ]

7.  Secondary:   Change in Uptake Between FLT1 and FLT3 to Predict Pathologic Complete Response (pCR) of the Primary Tumor   [ Time Frame: Baseline (FLT-1) and post-NAC (FLT-3) ]

8.  Secondary:   %Change SUVmax From FLT1‐FLT2 to Predict Lymph Node Status at Surgery   [ Time Frame: Baseline (FLT-1) and Early Therapy (FLT-2) ]

9.  Secondary:   %Change SUVmax From FLT1‐FLT3 to Predict Lymph Node Status at Surgery   [ Time Frame: Baseline (FLT-1) and post-NAC (FLT-3) ]


  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 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.
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: Ben Herman
Organization: ACRIN
phone: 401.863.9188
e-mail: bherman@stat.brown.edu


Publications of Results:

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00572728     History of Changes
Obsolete Identifiers: NCT00566293
Other Study ID Numbers: NCI-2009-00266
NCI-2009-00266 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ACRIN 6688 ( Other Identifier: American College of Radiology Imaging Network )
8029 ( Other Identifier: CTEP )
N01CM27165 ( US NIH Grant/Contract Award Number )
Study First Received: December 11, 2007
Results First Received: March 18, 2015
Last Updated: December 10, 2015
Health Authority: United States: Food and Drug Administration