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

NCT03113825 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2021-06-11

No results posted yet for this study

Summary

Phase 2, open-label study of AVB-620 in women with primary, nonrecurrent and nonmetastatic breast cancer undergoing surgery.

Conditions

  • Primary Invasive Malignant Neoplasm of Female Breast
  • Carcinoma Breast
  • Breast Cancer Female
  • Carcinoma, Ductal, Breast
  • Stage II Breast Cancer
  • Stage I Breast Cancer
  • Stage III Breast Cancer

Interventions

DEVICE

Investigational Imaging device

Fluorescence imaging of the of the primary tumor specimen, any secondary breast specimens, and lymph nodes will be performed.

DRUG

AVB-620

AVB-620 will be administered IV before the surgical procedure.

Sponsors & Collaborators

  • RRD International, Inc.

    collaborator UNKNOWN

  • Clinipace Worldwide

    collaborator INDUSTRY

  • Avelas Biosciences, Inc.

    lead INDUSTRY

Principal Investigators

  • Steven Chen, MD, MBA · Avelas Biosciences, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-05
Primary Completion
2020-04-08
Completion
2020-11-18
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03113825 on ClinicalTrials.gov