Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery

Overview

About this study

The purpose of this study is to evaluate the timing of AVB-620 administration relative to surgery on the fluorescence and accuracy of the AVB-620 imaging data to distinguish between malignant and nonmalignant tissues in women undergoing surgery with primary, nonrecurrent and nonmetastatic breast cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria:

  • DCIS or Stage I-III primary invasive carcinoma of the breast
  • Primary surgical treatment is lumpectomy + SLNB or ALND --or-- mastectomy + ALND
  • Signed written informed consent
  • At least 18 years of age
  • ECOG performance status 0 to 2
  • Life expectancy of at least 6 months
  • Total bilirubin ≤ 2 mg/dL
  • AST/SGOT and ALT/SGPT ≤ 2.5 X ULN
  • Negative serum pregnancy test and using medically acceptable form of contraception if of child bearing potential
  • LVEF within normal limits if patient received prior anthracycline therapy [Period 1]

Exclusion Criteria:

  • Recurrent ipsilateral breast cancer
  • Prior neoadjuvant chemotherapy, endocrine therapy, or biologic therapy for current breast cancer [Period 2]
  • Prior neoadjuvant chemo or biologic therapy for current breast cancer within 4 weeks prior to planned surgery [Period 1]
  • Open surgery in ipsilateral breast within 1 year
  • Prior malignancy, other than breast cancer, active within the last 6 months
  • Prior radiation therapy to the chest [Period 2]
  • Radiation therapy to ipsilateral breast [Period 1]
  • Abnormal cardiac rhythm not controlled with medication; Hx of stroke within 1 year; Hx of coronary events and/or heart failure within 1 year
  • Diagnosis of autoimmune disorder, including RA, SLE, or Sjogren's syndrome
  • Hx of drug-related anaphylactic reactions, severe allergic reactions related to drug; active diagnosis of uncontrolled airway hyperactivity, uncontrolled asthma, or asthma requiring oral corticosteroids
  • Hx of drug-induced acute tubular necrosis
  • Chronic renal failure or current evidence of moderate to severe renal impairment
  • Current diagnosis of any other active or clinically significant nonbreast cancer
  • Received systemic investigational drug within 6 weeks prior to AVB-620 administration or has received AVB-620 previously
  • Pregnant or breast feeding or plans to become pregnant within 6 months of AVB-620 administration
  • Unresolved acute toxicity from prior anticancer therapy

 

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Sarah McLaughlin, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Sarah McLaughlin, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Barbara Pockaj, M.D.

Closed for enrollment

Contact information:

No Contact

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions