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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00534274
• Date of registration: 20/09/2007
• Prospective Registration: No
• Primary sponsor: UNICANCER
• Public title: Positron Emission Tomography Using 3'-Deoxy-3'-(18F) Fluorothymidine in Treating Women With Locally Advanced Cancer in One Breast Who Are Receiving Chemotherapy
• Scientific 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
• Date of first enrolment: November 2006
• Target sample size: 97
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00534274
• Study type: Interventional
• Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: Olivier Couturier, MD
• Affiliation: Centre Hospitalier Regional et Universitaire d'Angers

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

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

Primary Outcome(s)

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]

Secondary Outcome(s)

Rate of thymidine kinase 1 (TK1) [Time Frame: Post surgery]

Immunohistochemical evaluation (estrogen and progesterone receptors, c-erbB2, Ki-67, e-cadherin) [Time Frame: 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]

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]

Toxicity by CTC-AE v. 3.0 [Time Frame: Post surgery]

Intensity of the tumoral uptake of 18F-FLT on initial exam visually and by SUV [Time Frame: post surgery]

Intensity of tumor uptake of 18F-FLT by standardized uptake value (SUV) [Time Frame: Post surgery]

Secondary ID(s)

EU-20754

2005-005166-37

FLT01 - UC-0140/0505

FRE-FNCLCC-FLT-01/0505

Source(s) of Monetary Support

Please refer to primary and secondary sponsors