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

Completed · Phase 2

Conditions studied: Stage IIB Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

In brief

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.

Key facts

Study ID

NCT00572728

Run by

National Cancer Institute (NCI)

People needed

90

Starts

2008-12-01

Expected to finish

2014-10-01

Last updated by the study team

2016-12-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Scottsdale Medical Imaging Limited — Scottsdale, Arizona, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Morton Plant Hospital — Clearwater, Florida, United States
• Morton Plant Mease — Dunedin, Florida, United States
• Ochsner Medical Center Jefferson — New Orleans, Louisiana, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Wayne State University/Karmanos Cancer Institute — Detroit, Michigan, United States
• Siteman Cancer Center at Washington University — St Louis, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• Mount Sinai Medical Center — New York, New York, United States
• Mount Sinai School of Medicine — New York, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Radiology Consultants Inc — Youngstown, Ohio, United States
• Penn State Milton S Hershey Medical Center — Hershey, Pennsylvania, United States
• American College of Radiology Imaging Network — Philadelphia, Pennsylvania, United States
• Hospital of The University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pennsylvania School of Medicine — Philadelphia, Pennsylvania, United States
• Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Excel Diagnostics — Houston, Texas, United States
• Westchase Oncology Center — Houston, Texas, United States
• Virginia Commonwealth University/Massey Cancer Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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