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89ZrTrastuzumab Breast Imaging With Positron Emission Tomography

Early Phase 1
Completed
Conditions
Breast Cancer
Interventions
Drug: 89Zr-Trastuzumab Human Dosimetry and Safety
Drug: HER2 Positive Lesion Detection and Safety
Registration Number
NCT02065609
Lead Sponsor
Washington University School of Medicine
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
52
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.
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Cohort 189Zr-Trastuzumab Human Dosimetry and Safety89Zr-Trastuzumab Human Dosimetry and Safety
Cohort 2: Lesion Detection and SafetyHER2 Positive Lesion Detection and SafetyHER2 Positive Lesion Detection and Safety
Cohort 1HER2 Positive Lesion Detection and Safety89Zr-Trastuzumab Human Dosimetry and Safety
Cohort 2: Lesion Detection and Safety89Zr-Trastuzumab Human Dosimetry and SafetyHER2 Positive Lesion Detection and Safety
Primary Outcome Measures
NameTimeMethod
Number of Participants With Adverse Events as a Measure of Safety and Tolerability After 89Zr-Trastuzumab Administration30 Days following 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Washington University School of Medicine @ Barnes-Jewish Hospital

🇺🇸

Saint Louis, Missouri, United States

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