Breast Cancer
Conditions
Keywords
stage II breast cancer, stage IIIA breast cancer
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.
Interventions
Sponsors
UNICANCER
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| 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 | Post surgery |
Secondary
| Measure | Time frame |
|---|---|
| Variation of tumoral uptake as seen by positron emission tomography (PET) before, during, and after therapy as determined visually and by SUV | Post surgery |
| Intensity of the tumoral uptake of 18F-FLT on initial exam visually and by SUV | 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) | post surgery |
| Intensity of tumor uptake of 18F-FLT by standardized uptake value (SUV) | Post surgery |
| Rate of thymidine kinase 1 (TK1) | Post surgery |
| Toxicity by CTC-AE v. 3.0 | Post surgery |
| Immunohistochemical evaluation (estrogen and progesterone receptors, c-erbB2, Ki-67, e-cadherin) | Post-surgery |
Countries
France
Outcome results
None listed