Positron Emission Tomography Using 3'-Deoxy-3'-(18F) Fluorothymidine in Treating Women With Locally Advanced Cancer in One Breast Who Are Receiving Chemotherapy
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|ClinicalTrials.gov Identifier: NCT00534274|
Recruitment Status : Completed
First Posted : September 24, 2007
Last Update Posted : December 16, 2014
RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) using 3'-deoxy-3'-(18F) fluorothymidine, may be effective in assessing the response to chemotherapy before surgery in treating locally advanced breast cancer.
PURPOSE: This clinical trial is studying how well positron emission tomography using 3'-deoxy-3'-(18F) fluorothymidine works in treating women with locally advanced cancer in one breast who are receiving chemotherapy.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: 3'-deoxy-3'-[18F]fluorothymidine||Not Applicable|
- Evaluate the efficacy of positron emission tomography (PET) utilizing 3'-deoxy-3'-(18F) fluorothymidine (^18F-FLT) to correctly identify response to neoadjuvant chemotherapy in women with locally advanced unilateral breast cancer.
- Correlate PET-^18F-FLT results with histological response.
- Evaluate the correlation of early changes in tumor uptake of ^18F-FLT after the first course of chemotherapy with complete response after treatment completion.
- Evaluate the correlation of early changes in tumor uptake of ^18F-FLT with histologic response in biopsies obtained after 1 course of chemotherapy.
- Determine if the initial intensity of tumor uptake is a predictive value of response to chemotherapy.
- Determine if initial intensity of tumor uptake of ^18F-FLT varies according to histologic type of tumor, indices of proliferation, and tumor cellularity before therapy.
- Determine if the tumor uptake of ^18F-FLT during therapy varies according to histologic type of tumor, indices of proliferation, and tumor cellularity before therapy.
- Evaluate the role of TK1 on the kinetics of ^18 F-FLT.
- Analyze serum.
- Research biomarkers of genomics, transcription, and proteomics.
- Evaluate the toxicity of ^18F-FLT.
OUTLINE: This is a multicenter study.
Patients receive 3'-deoxy-3'-(18F) fluorothymidine (^18F-FLT) IV and undergo positron emission tomography (PET) before the first and second courses of neoadjuvant chemotherapy. Patients receiving bisequential chemotherapy undergo ^18F-FLT-PET before the change in drugs (usually the fourth or fifth course). All patients undergo a final ^18F-FLT-PET after the last chemotherapy course but before surgery.
After completion of study therapy, patients are followed for 1 month.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||97 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Study of Positron Emission Tomography With 3'-Deoxy-3'-[18F] Fluoro-thymidine ([18F]-FLT) for the Evaluation of Response to Neoadjuvant Chemotherapy for Cancers of the Breast|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||September 2013|
|Experimental: TEP FLT||Other: 3'-deoxy-3'-[18F]fluorothymidine|
- Intensity of tumor uptake of 3'-deoxy-3'-(18F) fluorothymidine (18F-FLT) determined visually and correlated with histological or surgical response according to Sataloff criteria [ Time Frame: Post surgery ]
- Intensity of tumor uptake of 18F-FLT by standardized uptake value (SUV) [ Time Frame: Post surgery ]
- Variation of tumoral uptake as seen by positron emission tomography (PET) before, during, and after therapy as determined visually and by SUV [ Time Frame: Post surgery ]
- Intensity of the tumoral uptake of 18F-FLT on initial exam visually and by SUV [ Time Frame: post surgery ]
- Histologic parameters: type, grade, mitotic index, CCIS , and microbiopsy embols after first course of chemotherapy (and on microbiopsy before therapeutic change of sequence in patients receiving bisequential chemotherapy) [ Time Frame: post surgery ]
- Immunohistochemical evaluation (estrogen and progesterone receptors, c-erbB2, Ki-67, e-cadherin) [ Time Frame: Post-surgery ]
- Rate of thymidine kinase 1 (TK1) [ Time Frame: Post surgery ]
- Toxicity by CTC-AE v. 3.0 [ Time Frame: Post surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00534274
|Centre Hospitalier Regional et Universitaire d'Angers|
|Angers, France, 49033|
|Centre Paul Papin|
|Angers, France, 49036|
|Centre Hospitalier de la Cote Basque|
|Bayonne, France, 64100|
|Hopital Saint Andre|
|Bordeaux, France, 33075|
|CHU de Bordeaux - Hopital Pellegrin|
|Bordeaux, France, 33076|
|Polyclinique Bordeaux Nord Aquitaine|
|Bordeaux, France, 33300|
|CHU Hopital A. Morvan|
|Brest, France, 29609|
|Centre Regional Francois Baclesse|
|Caen, France, 14076|
|Centre Jean Perrin|
|Clermont-Ferrand, France, 63011|
|Centre de Lutte Contre le Cancer Georges-Francois Leclerc|
|Dijon, France, 21079|
|Centre Oscar Lambret|
|Lille, France, 59020|
|Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes|
|Marseille, France, 13273|
|CHU de la Timone|
|Marseille, France, 13385|
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|Centre Regional Rene Gauducheau|
|Nantes-Saint Herblain, France, 44805|
|CHR Hotel Dieu|
|Nantes, France, 44093|
|Centre Antoine Lacassagne|
|Nice, France, 06189|
|Hopital de l'Archet CHU de Nice|
|Nice, France, F-06202|
|Paris, France, 75475|
|Paris, France, 75970|
|Poitiers, France, 86021|
|Centre Henri Becquerel|
|Rouen, France, 76038|
|Centre Rene Huguenin|
|Saint Cloud, France, 92211|
|Centre Hospitalier Universitaire Bretonneau de Tours|
|Tours, France, 37044|
|Study Chair:||Olivier Couturier, MD||Centre Hospitalier Regional et Universitaire d'Angers|