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 @ 9:24 PM
Ignite Modification Date:
2025-12-24 @ 9:24 PM
NCT ID:
NCT02061332
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years.
* Subjects with biopsy-proven DCIS, DCIS with microinvasion, DCIS with invasive disease under 5 mm, or Paget's Disease of the nipple (DCIS of the nipple) who have not yet received definitive treatment.
* HER-2/neu positive tumor as determined by \>5% of tumor population expressing this marker by immunohistochemical staining 2+ using anti-HER-2/neu verified by Dr. Paul Zhang in the Department of Pathology.
* Women of childbearing age with a negative pregnancy test documented prior to enrollment.
* Subjects with ECOG Performance Status Score of 0 or 1 (Appendix D).
* Subjects willing to use birth control if necessary
* Subjects who have voluntarily signed a written Informed Consent in accordance with institutional policies after its contents have been fully explained to them.
Exclusion Criteria:
* Pregnant or lactating females (pregnancy testing to be performed within 7 days prior to administration of first dose of vaccine).
* Subjects who have had a complete excisional biopsy of their tumor.
* Subjects with suspicion of invasive disease \> 5mm by MRI performed within 2 months of study recruitment.
* Screen and exclude subjects with positive HIV or hepatitis C at baseline.
* Subjects with coagulopathies, including thrombocytopenia with platelet count \<75,000, INR \> 1.5 and partial thromboplastin time \> 50 sec
* Subjects with major cardiac illness MUGA \< 50% EF.
* Subjects with pre-existing medical illnesses or medications which might interfere with the study.
* Subjects with laboratory tests reflecting ¬\> grade 1 toxicity by NCI CTC version 3.0 including CBC, liver function tests, urinalysis, EKG if cannot be corrected on repeat test in 7 days.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02061332
Study Brief:
Protocol Section:
NCT02061332