Positron Emission Tomography Using 3'-Deoxy-3'-(18F) Fluorothymidine in Treating Women With Locally Advanced Cancer in One Breast Who Are Receiving Chemotherapy
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
4 other identifiers
interventional
97
1 country
24
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Nov 2006
Longer than P75 for not_applicable breast-cancer
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 20, 2007
CompletedFirst Posted
Study publicly available on registry
September 24, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedDecember 16, 2014
December 1, 2014
5.4 years
September 20, 2007
December 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
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
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
- +2 more secondary outcomes
Study Arms (1)
TEP FLT
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UNICANCERlead
Study Sites (24)
Centre Hospitalier Regional et Universitaire d'Angers
Angers, 49033, France
Centre Paul Papin
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Olivier Couturier, MD
Centre Hospitalier Regional et Universitaire d'Angers
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2007
First Posted
September 24, 2007
Study Start
November 1, 2006
Primary Completion
April 1, 2012
Study Completion
September 1, 2013
Last Updated
December 16, 2014
Record last verified: 2014-12