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

December 14, 2014 updated by: UNICANCER

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49033
        • Centre Hospitalier Regional et Universitaire d'Angers
      • Angers, France, 49036
        • Centre Paul Papin
      • Bayonne, France, 64100
        • Centre Hospitalier de la Cote Basque
      • Bordeaux, France, 33075
        • Hopital Saint Andre
      • Bordeaux, France, 33076
        • CHU de Bordeaux - Hôpital Pellegrin
      • Bordeaux, France, 33300
        • Polyclinique Bordeaux Nord Aquitaine
      • Brest, France, 29609
        • CHU Hopital A. Morvan
      • Caen, France, 14076
        • Centre Regional Francois Baclesse
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin
      • Dijon, France, 21079
        • Centre de Lutte Contre le Cancer Georges-Francois Leclerc
      • Lille, France, 59020
        • Centre Oscar Lambret
      • Marseille, France, 13385
        • CHU de la Timone
      • Marseille, France, 13273
        • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
      • Montpellier, France, 34298
        • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
      • Nantes, France, 44093
        • CHR Hotel Dieu
      • Nantes-Saint Herblain, France, 44805
        • Centre Regional Rene Gauducheau
      • Nice, France, F-06202
        • Hopital de l'Archet CHU de Nice
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Paris, France, 75970
        • Hôpital Tenon
      • Paris, France, 75475
        • Hôpital Saint-Louis
      • Poitiers, France, 86021
        • CHU Poitiers
      • Rouen, France, 76038
        • Centre Henri Becquerel
      • Saint Cloud, France, 92211
        • Centre René Huguenin
      • Tours, France, 37044
        • Centre Hospitalier Universitaire Bretonneau de Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TEP FLT
Other: 3'-deoxy-3'-[18F]fluorothymidine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: Post surgery
Post surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Intensity of tumor uptake of 18F-FLT by standardized uptake value (SUV)
Time Frame: Post surgery
Post surgery
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
Post surgery
Intensity of the tumoral uptake of 18F-FLT on initial exam visually and by SUV
Time Frame: post surgery
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)
Time Frame: post surgery
post surgery
Immunohistochemical evaluation (estrogen and progesterone receptors, c-erbB2, Ki-67, e-cadherin)
Time Frame: Post-surgery
Post-surgery
Rate of thymidine kinase 1 (TK1)
Time Frame: Post surgery
Post surgery
Toxicity by CTC-AE v. 3.0
Time Frame: Post surgery
Post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNICANCER

Investigators

  • Study Chair: Olivier Couturier, MD, Centre Hospitalier Regional et Universitaire d'Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

September 20, 2007

First Submitted That Met QC Criteria

September 20, 2007

First Posted (Estimate)

September 24, 2007

Study Record Updates

Last Update Posted (Estimate)

December 16, 2014

Last Update Submitted That Met QC Criteria

December 14, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLT01 - UC-0140/0505
  • FRE-FNCLCC-FLT-01/0505
  • EU-20754
  • 2005-005166-37 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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