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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Purpose
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 | Intervention |
|---|---|
|
Breast Cancer |
Other: 3'-deoxy-3'-[18F]fluorothymidine |
| Study Type: | Interventional |
| 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 ]
| Estimated Enrollment: | 100 |
| Study Start Date: | November 2006 |
| Estimated Study Completion Date: | September 2013 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: TEP FLT | Other: 3'-deoxy-3'-[18F]fluorothymidine |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Inclusion criteria:
Histologically confirmed unilateral breast cancer
- T2 or T3, any N, M0
- Unifocal by mammography and ultrasound
- 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:
- Bilateral disease
- Multifocal tumor
- Invasive grade I lobular cancer
- Metastatic disease
- Stage ≥ T4 disease
- Cutaneous invasion, major adherence, or inflammatory disease
- Tumor overexpressing c-erbB2 by IHC (HER 2+++)
- Suspected clinical or radiological lesion (examined or not)
PATIENT CHARACTERISTICS:
Inclusion criteria:
- ECOG performance status 0-1
- Female
- Menopausal status not specified
- Hematologic, hepatic, and renal function normal
- Not pregnant or nursing
- Fertile patients must use effective contraception
Exclusion criteria:
- Alcohol dependency or prior reaction to ethanol injection
- Impossible to receive study therapy due to geographical, social, or psychological reasons
- Prisoners or patients under supervision
PRIOR CONCURRENT THERAPY:
Inclusion criteria:
- See Disease Characteristics
Exclusion criteria:
- Participation in another concurrent therapeutic study with an experimental drug
Contacts and Locations| France | |
| 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 | |
| CHU de Bordeaux - Hopital Pellegrin | |
| Bordeaux, France, 33076 | |
| Polyclinique Bordeaux Nord Aquitaine | |
| Bordeaux, France, 33300 | |
| 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 | |
| Hopital de l'Archet CHU de Nice | |
| Nice, France, F-06202 | |
| Centre Antoine Lacassagne | |
| Nice, France, 06189 | |
| Hopital Tenon | |
| Paris, France, 75970 | |
| Hopital Saint-Louis | |
| Paris, France, 75475 | |
| CHU Poitiers | |
| 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 |
More Information
No publications provided
| Responsible Party: | UNICANCER |
| ClinicalTrials.gov Identifier: | NCT00534274 History of Changes |
| Other Study ID Numbers: | FLT01 - UC-0140/0505, FRE-FNCLCC-FLT-01/0505, EU-20754, 2005-005166-37 |
| Study First Received: | September 20, 2007 |
| Last Updated: | January 17, 2013 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by UNICANCER:
|
stage II breast cancer stage IIIA breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on June 17, 2013