Clinical Trial · NCT00572728

Phase II Study of Fluorine-18 3'-Deoxy-3'-Fluorothymidine (F-18-FLT) in Invasive Breast Cancer

Overview

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.

Sponsor

National Cancer Institute

Phase

Phase 2

Contacts

Lale Kostakoglu (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT00572728

Drug / Compound

FLT

Isotope(s):

Target(s):

cytosolic thymidine kinase 1

Ligand Class: Small Molecules

Eligibility

Inclusion

Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
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
Locally advanced breast cancer, not stage IV, and with a tumor size \>= 2 cm (as measured on imaging or estimated by physical exam)
Absolute neutrophil count \>= 1,500/ul
Residual tumor planned to be removed surgically following completion of neoadjuvant therapy
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
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
Leukocytes \>= 3,000/ul
Creatinine within normal institutional limits OR creatinine clearance \>= 30 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
No obvious contraindications for primary chemotherapy
Total bilirubin within normal institutional limits
Platelets \>= 100,000/ul
Able to lie still for 1.5 hours for PET scanning

Exclusion

Currently on hormone therapy as the primary systemic neoadjuvant 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
Previous treatment (chemotherapy, radiation, or surgery) to involved breast; including hormone therapy
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
Condition requiring anesthesia for PET scanning and/or unable to lie still for 1.5 hours
Medically unstable
History of allergic reactions attributed to compounds of similar chemical or biologic composition to F-18 fluorothymidine