Women with breast cancer receiving chemotherapy before or after surgery will receive intravenous iron to examine its effect on anaemia and anaemia-related symptoms during chemotherapy and up to 12 months after chemotherapy treatment.

Phase 3

Withdrawn

• Conditions: Anaemia and anaemia-related symptoms; Breast Cancer; Cancer - Breast; Blood - Anaemia; Metabolic and Endocrine - Other metabolic disorders

• Registration Number: ACTRN12620001105932
• Lead Sponsor: Breast Cancer Trials

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-26
• Last Update Posted: 18 July 2023

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Female
• Target Recruitment: 290

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified