NCT02065609

Brief Summary

The main purpose of this study is to see if Positron Emission Tomography (PET-Imaging) with 89Zr labeled trastuzumab can detect trastuzumab (HER2) positive breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P75+ for early_phase_1 breast-cancer

Timeline
Completed

Started Feb 2014

Typical duration for early_phase_1 breast-cancer

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 19, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2018

Completed
4.6 years until next milestone

Results Posted

Study results publicly available

October 6, 2022

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

3.9 years

First QC Date

February 5, 2014

Results QC Date

July 20, 2022

Last Update Submit

October 5, 2022

Conditions

Breast Cancer

Keywords

Trastuzumab

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Adverse Events as a Measure of Safety and Tolerability After 89Zr-Trastuzumab Administration

    Subjects medical record was followed for 30 days following 89Zr-Trastuzumab Administration for AE Assessment with AE being defined as Any unfavorable medical occurrence in a human subject who receives 89Zr-Trastuzumab and PET/CT imaging, including any abnormal sign, symptom, or disease. The event does not necessarily have to be causally related to injection of 89Zr-Trastuzumab or PET/CT imaging to qualify as an adverse event, just temporally related.

    30 Days following 89Zr-Trastuzumab Administration

Study Arms (2)

Cohort 1

EXPERIMENTAL

89Zr-Trastuzumab Human Dosimetry and Safety

Drug: 89Zr-Trastuzumab Human Dosimetry and SafetyDrug: HER2 Positive Lesion Detection and Safety

Cohort 2: Lesion Detection and Safety

EXPERIMENTAL

HER2 Positive Lesion Detection and Safety

Drug: 89Zr-Trastuzumab Human Dosimetry and SafetyDrug: HER2 Positive Lesion Detection and Safety

Interventions

89Zr-Trastuzumab Human Dosimetry and SafetyDRUG

PET Imaging following administration of 89Zr labeled Trastuzumab for calculation of human dosimetry and overall safety

Cohort 1Cohort 2: Lesion Detection and Safety
HER2 Positive Lesion Detection and SafetyDRUG

Detection of HER2 Positive Breast Cancer with 89Zr Labeled Trastuzumab and PET imaging

Cohort 1Cohort 2: Lesion Detection and Safety

Eligibility Criteria

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

You may qualify if:

  • Female patients 18 years of age or older
  • Cohort 1: Her2-positive (defined as 3+) or FISH HER2:CEP17 ratio \> 2 biopsy proven breast cancer
  • Cohort 2: Her2-positive (defined as 3+) or FISH HER2:CEP17 ratio \> 2 OR HER2negative (0 or 1+, 2+ and FISH negative) biopsy-proven breast cancer
  • Primary or recurrent/metastatic lesion size ≥ 1.5 cm as determined by imaging studies (ultrasonography, mammography, CT or MRI) or physical examination
  • Able to give informed consent
  • Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 89Zr-trastuzumab) is negative
  • Patients currently receiving trastuzumab therapy with or without other types of systemic therapy can participate if their disease progresses (development of new lesion(s) or worsening of known lesion(s) based on imaging modalities or physical examination.

You may not qualify if:

  • Patients with other invasive malignancies, with the exception of non- melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years
  • Unable to tolerate 60 min of PET imaging per imaging session

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine @ Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Safety

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Accident PreventionAccidentsPublic HealthEnvironment and Public Health

Results Point of Contact

Title
Dr. Farrokh Dehdashti
Organization
Washington University School of Medicine in St. Louis
dehdashtif@wustl.edu
314-362-1474

Study Officials

  • Farrokh Dehdashti, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Radiology

Study Record Dates

First Submitted

February 5, 2014

First Posted

February 19, 2014

Study Start

February 1, 2014

Primary Completion

December 31, 2017

Study Completion

February 13, 2018

Last Updated

October 13, 2022

Results First Posted

October 6, 2022

Record last verified: 2022-10

Locations

US(1)