Clinical trial NCT02391194: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: AVB-620
stage I
newly diagnosed
breast cancer
stage II
stage III
ductal carcinoma in situ
Lead sponsor: Avelas Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2015-03-18
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety of AVB-620 as assessed by the incidence of adverse events and abnormal laboratory values
timeFrame: 30 days
Secondary outcomes:
measure: Characterize the pharmacokinetic profile of AVB-620
timeFrame: 8 days
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Moores UC San Diego Cancer Center
state: California
city: San Francisco
country: United States
facility: UCSF Helen Diller Family Comprehensive Cancer Center
state: California
city: Stanford
country: United States
facility: Stanford Hospitals and Clinics
state: California
Study officials:
References: