To Evaluate the Characteristics of a Breast Cancer

Early Phase 1

Withdrawn

• Conditions: Breast Cancer
• Interventions: Drug: EF5; Procedure: Partial or Total Mastectomy

• Registration Number: NCT01055678
• Lead Sponsor: Mark Dewhirst

Brief Summary

The purpose of this pilot study is to determine the prevalence of markers of chronic and cycling hypoxia and reactive species stress (oxidative and nitrosative) in the breast cancer tumor microenvironment. The study is based around four cornerstone features of the pathologic microenvironment - Hypoxia, Reactive Species (reactive oxygen and nitrogen species), HIF-1 and VEGF, which we term the HRHV axis. Fifty breast cancer patients with planned surgical excision will be administered the hypoxia marker drug, EF5, 24-36 hr prior to surgical excision. EF5 is a non-therapeutic drug and provides no direct benefit to those patients enrolled in this pilot study. Tissues obtained intra-operatively will be snap frozen and subsequently analyzed for EF5 binding. Immunohistochemical analysis of a cohort of immunohistochemical and urine markers that depict the HRHV axis will be examined. The association of the markers with the presence of hypoxia, as determined by EF5 positivity, will be determined. Data from this pilot study will be used to establish the prevalence of markers of the HRHV axis in breast cancer. This information will be crucial for future human trials in which the HRHV axis is therapeutically targeted.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-24
• Study First Submitted QC: 2010-01-24
• Study First Posted: 2010-01-26
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-14
• Last Update Posted: 2012-12-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Histologically confirmed Stage 0 - III invasive carcinoma of the breast
• Tumor size greater than 1-cm by radiological (mammogram/ultrasound or MRI) evaluation
• KPS status ≥ 70
• Bilirubin ≤ 1.5x normal
• Creatinine ≤ 1.8
• WBC > 3000/mm^3 and platelets > 100,000/mm^3

Exclusion Criteria

• Pregnant or breast-feeding women
• Neoadjuvant chemo or hormonal therapy for existent breast malignancy
• Allergy to IV contrast dye
• History of grade III or IV peripheral neuropathy as defined by the NCI CTC
• Previous history of any malignancy treated with radiotherapy and/or chemohormonal therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All Patients	EF5	Single arm study analyzing tumor hypoxia after EF5 injection
All Patients	Partial or Total Mastectomy	Single arm study analyzing tumor hypoxia after EF5 injection

Primary Outcome Measures

Name	Time	Method
To evaluate tumor characteristics	2 years

Secondary Outcome Measures

Name	Time	Method
Intra and Interpatient correlations with tumor hypoxia	3 years

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States