89ZrTrastuzumab Breast Imaging With Positron Emission Tomography

Breast Cancer Clinical Trial

Official title:

Assessment of HER2 Receptors in Breast Carcinoma by Positron Emission Tomography (PET) Using 89 Zr-Trastuzumab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02065609
• Other study ID #: 201307037
• Secondary ID: R21CA182945
• Status: Completed
• Phase: Early Phase 1
• Start date: February 2014
• Est. completion date: February 13, 2018

Study information

• Verified date: October 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 13, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• 89Zr-Trastuzumab Human Dosimetry and Safety
PET Imaging following administration of 89Zr labeled Trastuzumab for calculation of human dosimetry and overall safety
• HER2 Positive Lesion Detection and Safety
Detection of HER2 Positive Breast Cancer with 89Zr Labeled Trastuzumab and PET imaging

Locations

Country	Name	City	State
United States	Washington University School of Medicine @ Barnes-Jewish Hospital	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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