Breast Cancer Foundation NZ
Safety and Efficacy of MagSense HER2 Test Reagent
Early Breast Cancer clinical trials for HER2+
This study will assess the safety and effectiveness of an investigational agent (MSH2TR) used to detect lymph node spread of cancer in patients with HER2+ breast cancer.
It is hoped this research will demonstrate that a single dose of MSH2TR is safe and well tolerated. It is also hoped that MSH2TR is an effective method for detecting HER2+ breast cancer that has spread to lymph nodes using MRI and MRX.
Who is it for?
You may be eligible for this study if you are a female aged 18 or older, you have histologically confirmed HER2+ primary breast cancer which you haven't had any prior treatment for (including surgery, radiotherapy, or systemic treatment) and you are scheduled for surgical intervention with lymph node detection by a specific diagnostic agent injection procedure being part of the surgical plan, or scheduled for a core biopsy of a lymph node that is clinically suspicious.
Study details
All enrolled participants will receive a subareolar (the pigmented area around the nipple) injection of the investigational agent after a baseline magnetic resonance imaging (MRI) scan on Day 1. The scan will last approximately 45 minutes.
Participants will return for another MRI in 24 hours (Day 2) and on Day 4 to detect the lymph node spread. Also on Day 4, participants will have a tissue sample (biopsy) taken from a cancerous lymph nodes for further examination. The biopsy will be investigated for standard of care as well as a new imaging technique called magnetic relaxometry (MRX).
As this study is investigating the safety of the investigational agent, participants will be asked to attend a series of seven clinic visits where they will provide up to three blood and urine samples.
Australia
Austin Hospital, Melbourne
Contact:
Geoff HollisIf you think you might be a candidate for this trial, use the contact details supplied, or talk to your doctor.
Want to access a trial that's not in your area? It's not always possible, but if you're interested, email us at intouch@bcf.org.nz
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For Early Breast Cancer
Are we out of date? If you have updated or new information about a trial, we’d be grateful if you’d share it with us – email your update to intouch@bcf.org.nz
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