Overview

This trial is active, not recruiting.

Conditions male breast cancer, stage ii breast cancer, stage iiia breast cancer, stage iiib breast cancer
Treatments fludeoxyglucose f 18, positron emission tomography, dynamic contrast-enhanced magnetic resonance imaging, laboratory biomarker analysis
Sponsor University of Washington
Collaborator National Cancer Institute (NCI)
Start date November 2011
End date February 2016
Trial size 65 participants
Trial identifier NCT01931709, 7587, NCI-2013-01668, P30CA015704, P50CA138293

Summary

This clinical trial studies fludeoxyglucose F 18 (FDG) positron emission tomography (PET) and dynamic contrast-enhanced (DCE)-magnetic resonance imaging (MRI) in predicting response to treatment in patients with breast cancer. Comparing results of diagnostic procedures done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).
fludeoxyglucose f 18 18FDG
Undergo FDG PET
positron emission tomography FDG-PET
Undergo FDG PET
dynamic contrast-enhanced magnetic resonance imaging DCE-MRI
Undergo DCE-MRI
laboratory biomarker analysis
Correlative studies

Primary Outcomes

Measure
Microscopic pathologic response, defined as no evidence of microscopic invasive tumor present at primary tumor site in the surgical specimen, as opposed to results "other than pathologic complete response (pCR)"
time frame: At time of surgery

Secondary Outcomes

Measure
Percent change in tumor perfusion
time frame: Baseline to up to 12 weeks (mid-therapy)
Percent change in tumor metabolism
time frame: Baseline to up to 12 weeks (mid-therapy)
Time from surgery to breast cancer recurrence or death
time frame: From surgery to breast cancer recurrence or death, assessed up to 5 years
Overall survival
time frame: From time of surgery until death, assessed up to 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

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 - Primary tumor 2.0 cm or greater, and/or clinical evidence of axillary disease (palpable N1 or N2 or biopsy proven) - No obvious contraindications for primary chemotherapy - Able to lie still for PET and MRI scanning - 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: - Serious systemic illness other than breast cancer - Contraindication to MRI or history of adverse reaction to gadolinium - Evidence of distant disease outside of regional lymph nodes - Pregnant - Poorly controlled diabetes mellitus (fasting blood glucose > 200) - Prior systemic cancer therapy

Additional Information

Official title Quantitative Dynamic PET and MRI and Breast Cancer Therapy
Principal investigator Jennifer Specht
Description PRIMARY OBJECTIVES: I. To determine whether detailed kinetic analysis of FDG PET and magnetic resonance (MR) imaging studies for measures of tumor metabolism and blood perfusion can predict response and outcome for breast cancer patients undergoing neo-adjuvant therapy. II. To compare the in vivo tumor biology associated with responsive and resistant tumors as measured by kinetic changes in FDG PET and MR imaging parameters to tumor subtypes analyzed from assay of pre-therapy biopsy and post-therapy surgical tissue. OUTLINE: Patients undergo FDG PET and DCE-MRI 1-2 weeks before prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of Washington.
Location data was received from the National Cancer Institute and was last updated in June 2016.