Positron Emission Tomography Using 3'-Deoxy-3'-(18F) Fluorothymidine in Treating Women With Locally Advanced Cancer in One Breast Who Are Receiving Chemotherapy
- Conditions
- Breast Cancer
- Interventions
- Other: 3'-deoxy-3'-[18F]fluorothymidine
- Registration Number
- NCT00534274
- Lead Sponsor
- UNICANCER
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
Primary
* 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.
Secondary
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 97
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TEP FLT 3'-deoxy-3'-[18F]fluorothymidine -
- Primary Outcome Measures
Name Time Method 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 Post surgery
- Secondary Outcome Measures
Name Time Method Variation of tumoral uptake as seen by positron emission tomography (PET) before, during, and after therapy as determined visually and by SUV Post surgery Intensity of tumor uptake of 18F-FLT by standardized uptake value (SUV) Post surgery Intensity of the tumoral uptake of 18F-FLT on initial exam visually and by SUV post surgery Immunohistochemical evaluation (estrogen and progesterone receptors, c-erbB2, Ki-67, e-cadherin) Post-surgery Rate of thymidine kinase 1 (TK1) 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) post surgery Toxicity by CTC-AE v. 3.0 Post surgery
Trial Locations
- Locations (24)
Centre Hospitalier Regional et Universitaire d'Angers
🇫🇷Angers, France
CHU de Bordeaux - Hopital Pellegrin
🇫🇷Bordeaux, France
Centre Hospitalier de la Cote Basque
🇫🇷Bayonne, France
Hopital Saint Andre
🇫🇷Bordeaux, France
Polyclinique Bordeaux Nord Aquitaine
🇫🇷Bordeaux, France
CHU Hopital A. Morvan
🇫🇷Brest, France
Centre Regional Francois Baclesse
🇫🇷Caen, France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
🇫🇷Dijon, France
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
Centre Oscar Lambret
🇫🇷Lille, France
CHU de la Timone
🇫🇷Marseille, France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
🇫🇷Marseille, France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
🇫🇷Montpellier, France
Centre Regional Rene Gauducheau
🇫🇷Nantes-Saint Herblain, France
CHR Hotel Dieu
🇫🇷Nantes, France
Centre Antoine Lacassagne
🇫🇷Nice, France
Hopital de l'Archet CHU de Nice
🇫🇷Nice, France
Hopital Saint-Louis
🇫🇷Paris, France
Hopital Tenon
🇫🇷Paris, France
Centre Rene Huguenin
🇫🇷Saint Cloud, France
CHU Poitiers
🇫🇷Poitiers, France
Centre Hospitalier Universitaire Bretonneau de Tours
🇫🇷Tours, France
Centre Henri Becquerel
🇫🇷Rouen, France
Centre Paul Papin
🇫🇷Angers, France