Positron Emission Tomography Using 3'-Deoxy-3'-(18F) Fluorothymidine in Treating Women With Locally Advanced Cancer in One Breast Who Are Receiving Chemotherapy
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|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|
- 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 ] [ Designated as safety issue: No ]
- Intensity of tumor uptake of 18F-FLT by standardized uptake value (SUV) [ Time Frame: Post surgery ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Intensity of the tumoral uptake of 18F-FLT on initial exam visually and by SUV [ Time Frame: post surgery ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Immunohistochemical evaluation (estrogen and progesterone receptors, c-erbB2, Ki-67, e-cadherin) [ Time Frame: Post-surgery ] [ Designated as safety issue: No ]
- Rate of thymidine kinase 1 (TK1) [ Time Frame: Post surgery ] [ Designated as safety issue: No ]
- Toxicity by CTC-AE v. 3.0 [ Time Frame: Post surgery ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2006|
|Study Completion Date:||September 2013|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00534274
|Centre Paul Papin|
|Angers, France, 49036|
|Centre Hospitalier Regional et Universitaire d'Angers|
|Angers, France, 49033|
|Centre Hospitalier de la Cote Basque|
|Bayonne, France, 64100|
|Polyclinique Bordeaux Nord Aquitaine|
|Bordeaux, France, 33300|
|CHU de Bordeaux - Hopital Pellegrin|
|Bordeaux, France, 33076|
|Hopital Saint Andre|
|Bordeaux, France, 33075|
|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|
|CHU de la Timone|
|Marseille, France, 13385|
|Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes|
|Marseille, France, 13273|
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|CHR Hotel Dieu|
|Nantes, France, 44093|
|Centre Regional Rene Gauducheau|
|Nantes-Saint Herblain, France, 44805|
|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|