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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 breast-cancer

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_1 breast-cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
14 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

1.8 years

First QC Date

February 20, 2015

Last Update Submit

March 21, 2017

Conditions

Breast Cancer

Keywords

AVB-620stage Inewly diagnosedbreast cancerstage IIstage IIIductal carcinoma in situ

Outcome Measures

Primary Outcomes (1)

  • Safety of AVB-620 as assessed by the incidence of adverse events and abnormal laboratory values

    The incidence, nature and severity of adverse events and abnormal laboratory values will be collected and analyzed in the evaluation of the safety of AVB-620.

    30 days

Secondary Outcomes (1)

  • Characterize the pharmacokinetic profile of AVB-620

    8 days

Study Arms (1)

AVB-620

EXPERIMENTAL

Eligible subjects will receive a single dose of AVB-620 as an intravenous infusion before the surgical procedure.

Drug: AVB-620

Interventions

AVB-620DRUG
AVB-620

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Moores UC San Diego Cancer Center

La Jolla, California, 92093, United States

Location

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

Stanford Hospitals and Clinics

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2015

First Posted

March 18, 2015

Study Start

April 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

March 22, 2017

Record last verified: 2017-03

Locations

US(3)