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Brief Title: Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery
Official Title: A Phase 1 Trial of AVB-620 in Women With Primary, Non-Recurrent Breast Cancer Undergoing Surgery
Study ID: NCT02391194
Brief Summary: This is a Phase 1, open-label, dose escalation study in women with primary, non-recurrent breast cancer undergoing surgery. AVB-620 will be administered prior to surgery.
Detailed Description: This study will examine the safety and tolerability of AVB-620 administered as an IV infusion to women with primary, non-recurrent breast cancer undergoing surgery. The study will also characterize the pharmacokinetics of AVB-620 in this subject population and determine the dose of AVB-620 needed to generate a fluorescence signal in tumor and lymph node tissue to enable fluorescence recordings and image analysis with an imaging system. The study will also evaluate the effect of timing of AVB-620 administration, relative to surgery, on fluorescence characteristics.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Moores UC San Diego Cancer Center, La Jolla, California, United States
UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
Stanford Hospitals and Clinics, Stanford, California, United States