89ZrTrastuzumab Breast Imaging With Positron Emission Tomography

The Washington University

Status and phase: Completed; Early Phase 1

Conditions: Breast Cancer

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02065609

201307037

R21CA182945 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Cohort 1

Experimental group

Description:

89Zr-Trastuzumab Human Dosimetry and Safety

Treatment:

Drug: HER2 Positive Lesion Detection and Safety

Drug: 89Zr-Trastuzumab Human Dosimetry and Safety

Cohort 2: Lesion Detection and Safety

Experimental group

Description:

HER2 Positive Lesion Detection and Safety

Treatment:

Drug: HER2 Positive Lesion Detection and Safety

Drug: 89Zr-Trastuzumab Human Dosimetry and Safety