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:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-25 @ 1:45 AM
NCT ID:
NCT02391194
Eligibility Criteria:
Inclusion Criteria:
* Ductal carcinoma in situ (DCIS) or Stage I-III, primary invasive carcinoma of the breast
* Primary surgical treatment is planned to be a mastectomy or lumpectomy. Sentinel lymph node (LN) biopsy or axillary LN dissection (ALND) is planned as part of the subject's therapy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Adequate renal function
* Lab values (hematology and chemistry) within institution's normal laboratory limits
* Willing to remain on-site for approximately 24 hours after administration of AVB-620 or, if required, stay overnight after the surgical procedure
* If the subject received neoadjuvant therapy, residual tumor is present (to be determined by the primary surgeon)
* If the subject received prior anthracycline therapy, the left ventricular ejection fraction (LVEF) must be within institution's normal limits
* Subject has the ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Recurrent ipsilateral breast cancer
* Prior neoadjuvant chemotherapy or biologic therapy for current clinically or biopsy-proven node positive breast cancer within 4 weeks before the planned surgery.
* Open surgery in the ipsilateral breast within 1 year of AVB-620 administration
* History of radiation therapy to ipsilateral breast
* Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events, and/or heart failure within 1 year of AVB-620 administration
* Diagnosis of autoimmune disorders
* History of drug-related anaphylactic reactions or allergic reactions; subjects with an active diagnosis of uncontrolled airway hyperactivity, uncontrolled asthma, or asthma requiring oral corticosteroids will be excluded
* History of renal disease or current evidence of renal disease
* Current diagnosis of any other active or clinically significant non-breast cancer
* Systemic investigational drug of any kind within 6 weeks of AVB-620 administration
* Pregnant or breast feeding
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT02391194
Study Brief:
Protocol Section:
NCT02391194