Patient case: 56-year-old female with breast cancer; genetic feature: ERBB2

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

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: 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

Relevance to patient case: not relevant