Clinical trial NCT00534274: Positron Emission Tomography Using 3'-Deoxy-3'-(18F) Fluorothymidine in Treating Women With Locally Advanced Cancer in One Breast Who Are Receiving Chemotherapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: stage II breast cancer
stage IIIA breast cancer
Lead sponsor: UNICANCER
Sponsor class: OTHER
First posted: 2007-09-24
Enrollment: 97
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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 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

Primary outcomes:
measure: 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
timeFrame: Post surgery
Secondary outcomes:
measure: Intensity of tumor uptake of 18F-FLT by standardized uptake value (SUV)
timeFrame: Post surgery
measure: Variation of tumoral uptake as seen by positron emission tomography (PET) before, during, and after therapy as determined visually and by SUV
timeFrame: Post surgery
measure: Intensity of the tumoral uptake of 18F-FLT on initial exam visually and by SUV
timeFrame: post surgery
measure: 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)
timeFrame: post surgery
measure: Immunohistochemical evaluation (estrogen and progesterone receptors, c-erbB2, Ki-67, e-cadherin)
timeFrame: Post-surgery
measure: Rate of thymidine kinase 1 (TK1)
timeFrame: Post surgery
measure: Toxicity by CTC-AE v. 3.0
timeFrame: Post surgery
Other outcomes:
Locations:
city: Angers
country: France
facility: Centre Hospitalier Regional et Universitaire d'Angers
city: Angers
country: France
facility: Centre Paul Papin
city: Bayonne
country: France
facility: Centre Hospitalier de la Cote Basque
city: Bordeaux
country: France
facility: Hopital Saint Andre
city: Bordeaux
country: France
facility: CHU de Bordeaux - Hopital Pellegrin
city: Bordeaux
country: France
facility: Polyclinique Bordeaux Nord Aquitaine
city: Brest
country: France
facility: CHU Hopital A. Morvan
city: Caen
country: France
facility: Centre Regional Francois Baclesse
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Dijon
country: France
facility: Centre de Lutte Contre le Cancer Georges-Francois Leclerc
city: Lille
country: France
facility: Centre Oscar Lambret
city: Marseille
country: France
facility: Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
city: Marseille
country: France
facility: CHU de la Timone
city: Montpellier
country: France
facility: Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
city: Nantes-Saint Herblain
country: France
facility: Centre Regional Rene Gauducheau
city: Nantes
country: France
facility: CHR Hotel Dieu
city: Nice
country: France
facility: Centre Antoine Lacassagne
city: Nice
country: France
facility: Hopital de l'Archet CHU de Nice
city: Paris
country: France
facility: Hopital Saint-Louis
city: Paris
country: France
facility: Hopital Tenon
city: Poitiers
country: France
facility: CHU Poitiers
city: Rouen
country: France
facility: Centre Henri Becquerel
city: Saint Cloud
country: France
facility: Centre Rene Huguenin
city: Tours
country: France
facility: Centre Hospitalier Universitaire Bretonneau de Tours
Study officials:
affiliation: Centre Hospitalier Regional et Universitaire d'Angers
name: Olivier Couturier, MD
role: STUDY_CHAIR
References: