None listed
Conditions
Brief summary
This study aims to find out if receiving intravenous iron ferric carboxymaltose (FCM) will reduce the incidence of anaemia while patients are receiving chemotherapy before or after surgery for breast cancer, and whether this is associated with an improvement in quality of life (QoL) and exercise tolerance. Who is it for? This study may be suitable if you are 18 years or older and will be starting adjuvant or neoadjuvant chemotherapy to treat early or locally advanced resected breast cancer. Trial Details Participants will be randomly allocated to receive either: 1) Iron ferric carboxymaltose (FCM) intravenously at baseline and further FCM if functional iron deficiency criteria are met OR 2) 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 3 weeks after the last dose of chemotherapy. Follow-up visits will occur at 3 months, 6 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 PROMIS Cognitive Function Short Form 8a (PROMIS-Cog 8a), Daily Cognition and Mood (DCAM) cognitive assessment, 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. It is hoped that this research will improve the quality of life of women undergoing adjuvant or neoadjuvant chemotherapy for breast cancer.
Interventions
Ferric carboxymaltose administered intravenously:
* At baseline 1000 mg for bodyweight >= 50 kg or 2 administrations of 500 mg each separated by at least a week for bodyweight < 50 kg
* Every 5-6 weeks (depending on chemotherapy regimen) for 17-25 weeks only if functional iron deficiency criteria is met (as determined by blood test) of ferritin < 100 ng/mL, or transferrin saturation < 20 % and ferritin < 300 ng/mL
Total dose during study 1000-2500 mg.
Sponsors
Breast Cancer Trials
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For inclusion in the study, participants must fulfil all the following criteria: 1) Provide written, informed consent to participate in the study 2) Female >= 18 years with Stage 1-3 (non-metastatic) breast cancer and: a) Planned for adjuvant chemotherapy of > 3 months duration following breast cancer surgery OR b) Planned for neoadjuvant chemotherapy of > 3 months duration before breast cancer surgery. i) Carboplatin may be weekly or 3 weekly in the neoadjuvant treatment of triple negative breast cancer Notes for adjuvant/neoadjuvant chemotherapy: * Acceptable chemotherapy regimens are: ddAC/EC-wPac; wPac-ddAC/EC; ddAC/EC-Doc; Doc-ddAC/EC; AC/EC-ddPac; ddPac-AC/EC; ddAC/EC-ddPac; ddPac-ddAC/EC; (F)EC-Doc; Doc-(F)EC; AC/EC-Doc; Doc-AC/EC; AC/EC-wPac; wPac-AC/EC ddAC-wPac; ddAC-Doc; ddAC-ddPac; FEC -Doc; AC-Doc; AC- wPac; TCH * For sequential anthracycline-taxane regimens the paclitaxel or docetaxel component may be administered before or after the anthracycline at the investigator’s discretion * The taxane component of treatment may include trastuzumab +/- pertuzumab (HER2-positive disease). 3) Haemoglobin >= 100g/L and <= 130 g/L 4) Either: a) Ferritin >= 30 ng/mL and < 100 ng/mL; OR b) TSAT < 20% AND ferritin < 300 ng/mL. 5) Physically able to complete baseline 6 Minute Walk Test 6) English language proficiency to complete Functional Capacity Assessments.
Exclusion criteria
Any one of the following is regarded as a criterion for exclusion from the study: 1) Hb < 100 g/L 2) Ferritin < 30 ng/mL 3) Prior intolerance or reaction to FCM or its constituents 4) 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 5) Known hypersensitivity reactions to IV iron 6) History of haemochromatosis 7) Intravenous iron therapy within 4 weeks before randomisation 8) Unstable angina within 1 month before randomisation 9) Myocardial infarction within 3 months before randomisation.
Outcome results
None listed