Breast Cancer Foundation NZ
RAPID EBC
This study aims to find out if receiving intravenous iron ferric carboxymaltose will reduce the incidence of anaemia while patients are receiving adjuvant chemotherapy for breast cancer, and whether this is associated with an improvement in quality of life and exercise tolerance.
This is a randomised phase III open-label trial to examine the effect of intravenous iron replacement on anaemia and anaemia-related symptoms in breast cancer patients receiving adjuvant chemotherapy. It is hoped that this research will improve the quality of life of women undergoing adjuvant chemotherapy for breast cancer.
Who is it for?
This study may be suitable if you are 18 years or older and will be starting adjuvant chemotherapy to treat early or locally advanced resected breast cancer.
Study details
Participants will be randomly allocated to receive either:
- Iron ferric carboxymaltose (FCM) intravenously at baseline and further FCM if functional iron deficiency criteria are met OR
- Standard of care during chemotherapy according to local guidelines.
All participants will be regularly monitored every 5-6 weeks (depending on the type of chemotherapy) throughout treatment to evaluate their health. There will be a final treatment visit one cycle-length after the last dose of chemotherapy. Follow-up visits will occur at six weeks, three months, six months and 12 months after the last dose of chemotherapy. Further treatment will be at the discretion of the participant and their treating clinician.
At each visit, all participants will:
- Complete online functional assessments to assess cognitive function, daily function and quality of life, using the FACT-COG, CogState(TM) and FACT-An
- Complete a 6 Minute Walk Test to evaluate exercise tolerance
- Have blood samples collected for additional assessments of iron parameters in the blood.
This trial is due to open in Q3/4 2021.
New Zealand
Australia
If 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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