Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-24 @ 1:33 PM
NCT ID:
NCT01878695
Eligibility Criteria:
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01878695
Study Brief:
Protocol Section:
NCT01878695