Breast Cancer Foundation NZ
BCT 2003
Advanced Breast Cancer clinical trials for ER+
Pending
Updated: January 20, 2022
This study will look at the effect of intravenous iron on anaemia and anaemia-related symptoms during chemotherapy and up to 12 months after chemotherapy treatment.
Women with breast cancer receiving adjuvant chemotherapy will receive intravenous iron to examine its effect on anaemia and anaemia-related symptoms during chemotherapy and up to 12 months after chemotherapy treatment.
Key inclusion criteria
- Provide written, informed consent to participate in the study
- Female >= 18 years with Stage 1-3 (non-metastatic) resected breast cancer
- Planned for adjuvant chemotherapy of > 3 months duration following breast cancer surgery. Acceptable chemotherapy regimens are: ddAC-wPac; ddAC-Doc; ddAC-ddPac; FEC -Doc; AC-Doc; AC- wPac; TCH. Regimens may include trastuzumab +/- pertuzumab.
- Haemoglobin < 130 g/L.
- Either:
- Ferritin < 100 ng/mL; OR
- TSAT < 20% AND ferritin < 300 ng/mL.
- Physically able to complete baseline 6 Minute Walk Test.
- English language proficiency to complete Functional Capacity Assessments
Key exclusion criteria
- Hb < 100 g/L.
- Ferritin < 30 ng/mL
- Prior intolerance or reaction to FCM or its constituents.
- Prior or planned neoadjuvant chemotherapy.
- Planned surgery within 6 weeks after completing chemotherapy.
- Known haemoglobinopathy, including, but not limited to sickle cell anaemia and thalassemia. Participants with other forms of chronic anaemia such as myelodysplasia and aplastic anaemia are also excluded.
- Known hypersensitivity reactions to IV iron.
- History of haemochromatosis.
- Intravenous iron therapy within 4 weeks before randomisation
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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