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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Recurrent Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

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Trial Information

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


PRIMARY OBJECTIVES:

I. To evaluate the relationship between 3'-deoxy-3'-18F fluorothymidine ([18F]FLT) uptake
parameters and pathologic complete response to chemotherapy of the primary tumor in patients
with locally advanced breast cancer.

SECONDARY OBJECTIVES:

I. To evaluate the relationship between [18F]FLT uptake parameters and the clinical
anatomical (CT) and metabolic (fludeoxyglucose [FDG] PET uptake) response.

II. To compare the utility of [18F]FLT and [18F]FDG uptake parameters for predicting early
treatment response (response assessment prior to completion of therapy) in patients with
locally advanced breast cancer.

III. To demonstrate correlation between [18F]FLT uptake parameters and tumor proliferation
markers in breast cancer.

IV. To continue to monitor for potential safety issues and define any physiologic effects
associated with [18F]FLT administration.

OUTLINE: This is a multicenter study.

On day 1, patients undergo 3'-deoxy-3'-(18F) fluorothymidine ( [18F]FLT) injection and
immediately dynamic regional positron emission tomography (PET)/CT imaging for 60 minutes,
followed by a static whole body image over approximately 30 minutes. A second static whole
body image is taken at 120 minutes post [18F]FLT injection.

On day 2, patients undergo[18F]FDG injection and PET/CT imaging 1 hour after injection. An
additional regional PET/CT image including the primary tumor in the field of view is
performed beginning at 2 hours after the injection of [18F]FDG.

Patients undergo three 2-day imaging sessions at baseline before neoadjuvant chemotherapy,
mid-neoadjuvant chemotherapy, and post-neoadjuvant chemotherapy before surgery. At the
beginning and end of each imaging session, patients complete a questionnaire indicating any
appearance or change in signs and symptoms.

After completion of neoadjuvant chemotherapy, patients undergo surgical resection of
residual tumor as planned.


Inclusion Criteria:



- Pathologically confirmed breast cancer

- Female patients must meet 1 of the following criteria:

- Postmenopausal for a minimum of one year

- Surgically sterile

- not pregnant, confirmed by β-HCG blood test and willing to use adequate
contraception during study participation

- Tumor size > 2 cm measured by imaging or estimated by physical exam

- Candidate for primary systemic (neoadjuvant) therapy and for surgical resection of
residual primary tumor following completion of neoadjuvant therapy

- WBC >= 3,000/microL

- Total bilirubin normal

- AST/ALT =< 2.5 x upper limit of normal

- Creatinine normal or creatinine clearance >= 60 mL/min

- Able to lie still for 1.5 hours

- No obvious contraindications for primary chemotherapy with docetaxel, doxorubicin
hydrochloride, or cyclophosphamide

- Platelet count >= 100,000/microL

- No previous treatment (e.g., chemotherapy, radiotherapy, or surgery) that involved
the breast

- Absolute neutrophil count >= 1,500/microL

Exclusion Criteria:

- Not nursing

- Must be medically stable

- No uncontrolled intercurrent illness including, but not limited to, any of the
following:

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Psychiatric illness/social situations that would limit compliance with study
requirements

- No condition requiring anesthesia for positron emission tomography (PET) scanning

- No history of allergic reactions attributed to compounds of similar chemical or
biologic composition to 3'-deoxy-3'-18F fluorothymidine

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Change in FLT uptake between the baseline (pre-therapy) and the early-therapy imaging studies using pathological complete response as a gold standard

Outcome Description:

To test if FLT uptake measures have any predictive (discriminating) ability, the Receiver Operating Characteristic (ROC) curve will be estimated and the area under the curve, along with its 95% confidence interval, will be determined.

Outcome Time Frame:

Baseline to 2 years

Safety Issue:

No

Principal Investigator

Lale Kostakoglu

Investigator Role:

Principal Investigator

Investigator Affiliation:

American College of Radiology Imaging Network

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00266

NCT ID:

NCT00572728

Start Date:

December 2008

Completion Date:

Related Keywords:

  • Recurrent Breast Cancer
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Breast Neoplasms

Name

Location
American College of Radiology Imaging Network Philadelphia, Pennsylvania  19103