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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00534274
• Other study ID #: FLT01 - UC-0140/0505
• Secondary ID: FRE-FNCLCC-FLT-0
• Status: Completed
• Phase: N/A
• First received: September 20, 2007
• Last updated: December 14, 2014
• Start date: November 2006
• Est. completion date: September 2013

Study information

• Verified date: December 2014
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: September 2013
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• 3'-deoxy-3'-[18F]fluorothymidine

Locations

Country	Name	City	State
France	Centre Hospitalier Regional et Universitaire d'Angers	Angers
France	Centre Paul Papin	Angers
France	Centre Hospitalier de la Cote Basque	Bayonne
France	CHU de Bordeaux - Hopital Pellegrin	Bordeaux
France	Hopital Saint Andre	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	CHU de la Timone	Marseille
France	Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes	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

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Intensity of tumor uptake of 18F-FLT by standardized uptake value (SUV)		Post surgery	No
Secondary	Variation of tumoral uptake as seen by positron emission tomography (PET) before, during, and after therapy as determined visually and by SUV		Post surgery	No
Secondary	Intensity of the tumoral uptake of 18F-FLT on initial exam visually and by SUV		post surgery	No
Secondary	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	No
Secondary	Immunohistochemical evaluation (estrogen and progesterone receptors, c-erbB2, Ki-67, e-cadherin)		Post-surgery	No
Secondary	Rate of thymidine kinase 1 (TK1)		Post surgery	No
Secondary	Toxicity by CTC-AE v. 3.0		Post surgery	Yes