Phase II Study of Fluorine-18 3'-Deoxy-3'-Fluorothymidine (F-18-FLT) in Invasive Breast Cancer
Condition: Stage IIB Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: CT; 18F-FLT; PET
Intervention description: Undergo 18F-FLT PET/CT; Undergo 18F-FLT PET/CT; Undergo 18F-FLT PET/CT
Intervention MeSH terms: Alovudine; Dideoxynucleosides
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well 3'-deoxy-3'-18F fluorothymidine (18F-FLT) positron
      emission tomography (PET)/computed tomography (CT) works in predicting response in patients
      receiving chemotherapy and undergoing surgery for breast cancer that has spread from where it
      started to nearby tissue or lymph nodes. Diagnostic procedures, such as 18F-FLT PET/CT, may
      help in learning how well chemotherapy works to kill breast cancer cells before surgery and
      help doctors plan the best treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Pathologically confirmed breast cancer, determined to be a candidate for primary
             systemic (neoadjuvant) therapy and for surgical resection of residual primary tumor
             following completion of neoadjuvant therapy

          -  Locally advanced breast cancer, not stage IV, and with a tumor size >= 2 cm (as
             measured on imaging or estimated by physical exam)

          -  No obvious contraindications for primary chemotherapy

          -  Residual tumor planned to be removed surgically following completion of neoadjuvant
             therapy

          -  Able to lie still for 1.5 hours for PET scanning

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

          -  Leukocytes >= 3,000/ul

          -  Absolute neutrophil count >= 1,500/ul

          -  Platelets >= 100,000/ul

          -  Total bilirubin within normal institutional limits

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
             =< 2.5 times the institutional upper limit of normal

          -  Creatinine within normal institutional limits OR creatinine clearance >= 30
             mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

          -  If female, postmenopausal for a minimum of one year, OR surgically sterile, OR not
             pregnant, confirmed by institutional standard of care (SOC) pregnancy test, and
             willing to use adequate contraception (hormonal or barrier method of birth control;
             abstinence) for the duration of study participation

          -  Able to understand and willing to sign a written informed consent document and a
             Health Insurance Portability and Accountability Act (HIPAA) authorization in
             accordance with institutional guidelines

        Exclusion Criteria:

          -  Previous treatment (chemotherapy, radiation, or surgery) to involved breast; including
             hormone therapy

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Medically unstable

          -  Condition requiring anesthesia for PET scanning and/or unable to lie still for 1.5
             hours

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to F-18 fluorothymidine

          -  Pregnant or nursing

          -  Previous malignancy, other than basal cell or squamous cell carcinoma of the skin or
             in situ carcinoma of the cervix, from which the patient has been disease free for less
             than 5 years

          -  Currently on hormone therapy as the primary systemic neoadjuvant therapy