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| ID | Type | Description | Link |
|---|---|---|---|
| FRE-FNCLCC-FLT-01/0505 | |||
| EU-20754 | |||
| 2005-005166-37 | EudraCT Number |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TEP FLT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3'-deoxy-3'-[18F]fluorothymidine | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of tumor uptake of 18F-FLT by standardized uptake value (SUV) | Post surgery | |
| Variation of tumoral uptake as seen by positron emission tomography (PET) before, during, and after therapy as determined visually and by SUV | Post surgery |
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DISEASE CHARACTERISTICS:
Inclusion criteria:
Histologically confirmed unilateral breast cancer
Negative for c-erbB2 by immunohistochemistry (IHC)
Planning neoadjuvant chemotherapy comprising anthracyclines and/or taxanes, alone or combined
Measurable disease by ultrasound
Hormone receptor status not specified
Exclusion criteria:
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Olivier Couturier, MD | Centre Hospitalier Regional et Universitaire d'Angers | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Regional et Universitaire d'Angers | Angers | 49033 | France | |||
| Centre Paul Papin |
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| Intensity of the tumoral uptake of 18F-FLT on initial exam visually and by SUV | 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 |
| Immunohistochemical evaluation (estrogen and progesterone receptors, c-erbB2, Ki-67, e-cadherin) | Post-surgery |
| Rate of thymidine kinase 1 (TK1) | Post surgery |
| Toxicity by CTC-AE v. 3.0 | Post surgery |
| Angers |
| 49036 |
| France |
| Centre Hospitalier de la Cote Basque | Bayonne | 64100 | France |
| Hopital Saint Andre | Bordeaux | 33075 | France |
| CHU de Bordeaux - Hopital Pellegrin | Bordeaux | 33076 | France |
| Polyclinique Bordeaux Nord Aquitaine | Bordeaux | 33300 | France |
| CHU Hopital A. Morvan | Brest | 29609 | France |
| Centre Regional Francois Baclesse | Caen | 14076 | France |
| Centre Jean Perrin | Clermont-Ferrand | 63011 | France |
| Centre de Lutte Contre le Cancer Georges-Francois Leclerc | Dijon | 21079 | France |
| Centre Oscar Lambret | Lille | 59020 | France |
| Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes | Marseille | 13273 | France |
| CHU de la Timone | Marseille | 13385 | France |
| Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | Montpellier | 34298 | France |
| CHR Hotel Dieu | Nantes | 44093 | France |
| Centre Regional Rene Gauducheau | Nantes-Saint Herblain | 44805 | France |
| Centre Antoine Lacassagne | Nice | 06189 | France |
| Hopital de l'Archet CHU de Nice | Nice | F-06202 | France |
| Hopital Saint-Louis | Paris | 75475 | France |
| Hopital Tenon | Paris | 75970 | France |
| CHU Poitiers | Poitiers | 86021 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| Centre Rene Huguenin | Saint-Cloud | 92211 | France |
| Centre Hospitalier Universitaire Bretonneau de Tours | Tours | 37044 | France |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C002854 | alovudine |
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