Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Demographic • Females ≥18 years of age
Disease related
Stage 0/I breast cancer by biopsy (patients may be consented and screened with suspected breast cancer, but no treatment will occur until cancer is confirmed by their biopsy).
Awaiting surgery which will consist of either lumpectomy or mastectomy.
ECOG performance status 0-1
Laboratory
Laboratory values that would not prevent the patient from receiving treatment as determined by the PI or study oncologist
Serum creatinine ≤2.0 mg/dL
Serum bilirubin ≤2.0 X ULN
Serum HgB ≥8.0 mg/dL
General
Competent to comprehend, sign, and date an IRB-approved informed consent form
Female subjects of childbearing potential have a negative pregnancy test
You may not be if
Disease Related
* History or known presence of metastases
* History of another primary cancer, except:
Curatively treated cervical carcinoma in situ, or
Curatively resected non-melanomatous skin cancer, or
Other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≤ 3 years prior to enrollment
* Other concurrent anticancer chemotherapy within 4 weeks as determined by the PI
* Any co-morbid disease that would increase risk of toxicity as determined by PI
Medications/Treatments
Subjects requiring chronic use of immunosuppressive agents (eg, methotrexate, cyclosporine, corticosteroids)
Recent infection requiring a course of systemic anti-infectives that was completed ≤ 14 days prior to enrollment (exception can be made at the judgment of the PI for oral treatment of an uncomplicated urinary tract infection (\[UTI\])
General
History of any medical or psychiatric condition or addictive disorder, or laboratory abnormality that, in the opinion of the PI, may increase the risks associated with study participation or study drug administration or may interfere with the conduct of the study or interpretation of study requirements
History of bronchospasm or severe asthma as determined by the PI
Subject unwilling or unable to comply with study requirements
Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection
Documented history of alcohol, cocaine or intravenous drug abuse ≤ 6 months of enrollment
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