Positron Emission Tomography Using 3'-Deoxy-3'-(18F) Fluorothymidine in Treating Women With Locally Advanced Cancer in One Breast Who Are Receiving Chemotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UNICANCER
ClinicalTrials.gov Identifier:
NCT00534274
First received: September 20, 2007
Last updated: January 17, 2013
Last verified: January 2013
  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

Resource links provided by NLM:


Further study details as provided by UNICANCER:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00534274

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
Sponsors and Collaborators
UNICANCER
Investigators
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
Alovudine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014