To Evaluate the Characteristics of a Breast Cancer

Mark Dewhirst

Status and phase: Withdrawn; Early Phase 1

Conditions: Breast Cancer

Treatments: Procedure: Partial or Total Mastectomy; Drug: EF5

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01055678

Pro00020382

R01CA040355 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

All Patients

Experimental group

Description:

Single arm study analyzing tumor hypoxia after EF5 injection

Treatment:

Procedure: Partial or Total Mastectomy

Drug: EF5