Positron Emission Tomography Using 3'-Deoxy-3'-(18F) Fluorothymidine in Treating Women With Locally Advanced Cancer in One Breast Who Are Receiving Chemotherapy
NCT ID: NCT00534274
Last Updated: 2014-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
97 participants
INTERVENTIONAL
2006-11-30
2013-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TEP FLT
3'-deoxy-3'-[18F]fluorothymidine
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
3'-deoxy-3'-[18F]fluorothymidine
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
* See Disease Characteristics
Exclusion Criteria
* 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:
* 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:
* Participation in another concurrent therapeutic study with an experimental drug
18 Years
65 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
UNICANCER
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Olivier Couturier, MD
Role: STUDY_CHAIR
Centre Hospitalier Regional et Universitaire d'Angers
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre Hospitalier Regional et Universitaire d'Angers
Angers, , France
Centre Paul Papin
Angers, , France
Centre Hospitalier de la Cote Basque
Bayonne, , France
Hopital Saint Andre
Bordeaux, , France
CHU de Bordeaux - Hopital Pellegrin
Bordeaux, , France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, , France
CHU Hopital A. Morvan
Brest, , France
Centre Regional Francois Baclesse
Caen, , France
Centre Jean Perrin
Clermont-Ferrand, , France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, , France
Centre Oscar Lambret
Lille, , France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, , France
CHU de la Timone
Marseille, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , France
CHR Hotel Dieu
Nantes, , France
Centre Regional Rene Gauducheau
Nantes-Saint Herblain, , France
Centre Antoine Lacassagne
Nice, , France
Hopital de l'Archet CHU de Nice
Nice, , France
Hopital Saint-Louis
Paris, , France
Hopital Tenon
Paris, , France
CHU Poitiers
Poitiers, , France
Centre Henri Becquerel
Rouen, , France
Centre Rene Huguenin
Saint-Cloud, , France
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FRE-FNCLCC-FLT-01/0505
Identifier Type: -
Identifier Source: secondary_id
EU-20754
Identifier Type: -
Identifier Source: secondary_id
2005-005166-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
FLT01 - UC-0140/0505
Identifier Type: -
Identifier Source: org_study_id