The general objective of the study is to improve the care of women with Human Epidermal Growth Factor Receptor-2 (HER2) positive metastatic or locally advanced breast cancer by using a radio-labelled biomarker with whole body Single Photon Emission Computed Tomography (SPECT) imaging to predict who will respond to treatment with Trastuzumab.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
3
111In-PmAb will be provided ready for injection in a vial by Dr. Reilly's laboratory.
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada
Change in tumour SUV (Standardized Uptake Value) from baseline to Day 8.
The imaging outcome for exploring the association between imaging and clinical outcome is the percent change in tumour SUV from baseline to Day 8 (Day 8 SUV - baseline SUV) /baseline SUV times 100%. The Positron Emission Tomography Evaluation Response Criteria In Solid Tumours (PERCIST) criterion will be used to measure SUV change.
Time frame: 8 days
Safety attributable to 111In-Pertuzumab injections
The safety, i.e. toxicities, attributable to 111In-Pertuzumab injections will be evaluated using the National Cancer Institute (NCI) Common Termination for Adverse Events Version 4.
Time frame: 3 months
Pharmacokinetics (PK) and tumour and normal tissue localization properties of 111In-PmAb will be measured.
The pharmacokinetics of 111In-PmAb and tumour and normal tissue localization properties of 111In-PmAb will be measured. Standard PK parameters (t1/2 alpha, t1/2β, V1, Vss and CL) will be calculated.
Time frame: 3 months
Optimal mass dose of 111In-PmAb
The dose of 111In-PmAb that is associated with the optimal SPECT-CT images will be established.
Time frame: 3 months
Change in tumour SUV from Baseline to Day 36
The imaging outcome for exploring the association between imaging and clinical outcome is the percent change in tumour SUV from baseline to Day 36 (Day 36 SUV - baseline SUV) /baseline SUV times 100%. The Positron Emission Tomography Evaluation Response Criteria In Solid Tumours (PERCIST) criterion will be used to measure SUV change.
Time frame: 3 months
Clinical response (complete or partial) to treatment will be measured using Response Evaluation Criteria In Solid Tumours (RECIST) criteria.
Clinical response (complete or partial) to treatment will be measured using Response Evaluation Criteria In Solid Tumours (RECIST) criteria.
Time frame: 3 months
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