Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery (NCT03113825) | Clinical Trial Compass
CompletedPhase 2
Study of AVB-620 in Women With Primary, Nonrecurrent Breast Cancer Undergoing Surgery
United States92 participantsStarted 2017-07-05
Plain-language summary
Phase 2, open-label study of AVB-620 in women with primary, nonrecurrent and nonmetastatic breast cancer undergoing surgery.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 re…
What they're measuring
1
Determine the accuracy of AVB-620 imaging data to distinguish between malignant and nonmalignant tissues.