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Trial registered on ANZCTR


Registration number
ACTRN12620001105932p
Ethics application status
Not yet submitted
Date submitted
1/09/2020
Date registered
26/10/2020
Date last updated
26/10/2020
Date data sharing statement initially provided
26/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
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.
Scientific title
BCT 2003: 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
Secondary ID [1] 301252 0
Nil known
Universal Trial Number (UTN)
Trial acronym
BCT 2003 RAPID EBC (Reducing Anaemia with Parenteral Iron Delivery in Early Breast Cancer chemotherapy)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anaemia and anaemia-related symptoms 317429 0
Breast Cancer 319224 0
Condition category
Condition code
Cancer 315522 315522 0 0
Breast
Blood 317186 317186 0 0
Anaemia
Metabolic and Endocrine 317187 317187 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 317553 0
Treatment: Drugs
Comparator / control treatment
Standard of care (as per local guidelines)
Control group
Active

Outcomes
Primary outcome [1] 323762 0
The proportion of women with a haemoglobin (Hb) below 100 g/L as measured by standard haematology assessments.
Timepoint [1] 323762 0
At any point after baseline during adjuvant chemotherapy until 6 weeks after last dose.
Secondary outcome [1] 382822 0
The frequency of hypersensitivity and anaphylaxis (composite outcome) to FCM in the study population measured by adverse event reporting as observed by study doctors in the 30 minutes after FCM administration.
Timepoint [1] 382822 0
At the end of FCM treatment (17-25 weeks, depending on chemotherapy regimen)
Secondary outcome [2] 382823 0
To compare the change in exercise tolerance during and following a course of adjuvant chemotherapy of FCM treated women with the control group using the 6 Minute Walk Test.
Timepoint [2] 382823 0
Mean changes in scores from baseline and at 6 weeks, and 3-, 6- and 12-months following completion of chemotherapy.
Secondary outcome [3] 382824 0
To compare the use of interventions for the management of anaemia (red cell transfusion, chemotherapy dose modification or treatment delay, non-protocol mandated administration of oral or IV iron) as reported on the CRF during the study.
Timepoint [3] 382824 0
At the end of FCM treatment (17-25 weeks, depending on chemotherapy regimen)
Secondary outcome [4] 382825 0
To compare anaemia-related symptoms and QoL (composite endpoint) between groups utilising the FACT-AN questionnaire.
Timepoint [4] 382825 0
Mean changes in FACT-AN scores from baseline and at 6 weeks, and 3-, 6- and 12-months following completion of chemotherapy.
Secondary outcome [5] 382826 0
To compare subjective changes in cognitive function between FCM treated subjects and controls using the FACT-COG assessment.
Timepoint [5] 382826 0
Mean changes in FACT-COG scores from baseline and at 6 weeks, and 3-, 6- and 12-months following completion of chemotherapy.
Secondary outcome [6] 382827 0
To compare objective changes in cognitive function between FCM treated subjects and controls using the CogState(TM) online assessment.
Timepoint [6] 382827 0
Mean changes in CogState(TM) scores from baseline and at 6 weeks, and 3-, 6- and 12-months following completion of chemotherapy.

Eligibility
Key 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) resected breast cancer
3) 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.
4) Haemoglobin < 130 g/L.
5) Either:
a) Ferritin < 100 ng/mL; OR
b) TSAT < 20% AND ferritin < 300 ng/mL.
6) Physically able to complete baseline 6 Minute Walk Test.
7) English language proficiency to complete Functional Capacity Assessments.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key 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) Prior or planned neoadjuvant chemotherapy.
5) Planned surgery within 6 weeks after completing chemotherapy.
6) 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.
7) Known hypersensitivity reactions to IV iron.
8) History of haemochromatosis.
9) Intravenous iron therapy within 4 weeks before randomisation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,VIC
Recruitment outside Australia
Country [1] 22549 0
New Zealand
State/province [1] 22549 0

Funding & Sponsors
Funding source category [1] 305699 0
Other Collaborative groups
Name [1] 305699 0
Breast Cancer Trials
Address [1] 305699 0
PO Box 283
The Junction NSW 2291
Country [1] 305699 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Breast Cancer Trials
Address
PO Box 283
The Junction NSW 2291
Country
Australia
Secondary sponsor category [1] 306116 0
None
Name [1] 306116 0
Address [1] 306116 0
Country [1] 306116 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 305977 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 305977 0
Level 3, Roma Mitchell House
136 North Terrace
ADELAIDE SA 5000
Ethics committee country [1] 305977 0
Australia
Date submitted for ethics approval [1] 305977 0
31/03/2021
Approval date [1] 305977 0
Ethics approval number [1] 305977 0

Summary
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 adjuvant chemotherapy 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 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 1 cycle-length after the last dose of chemotherapy. Follow-up visits will occur at 6 weeks, 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 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.

It is hoped that this research will improve the quality of life of women undergoing adjuvant chemotherapy for breast cancer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 102282 0
A/Prof Nick Murray
Address 102282 0
Royal Adelaide Hospital
Cancer Clinical Trials (MDP 46)
Level 6E-351
Port Road
ADELAIDE SA 5000
Country 102282 0
Australia
Phone 102282 0
+61 2 4925 5235
Fax 102282 0
Email 102282 0
corinna.beckmore@bctrials.org.au
Contact person for public queries
Name 102283 0
Ms Corinna Beckmore
Address 102283 0
Breast Cancer Trials
PO Box 283
The Junction NSW 2291
Country 102283 0
Australia
Phone 102283 0
+61 2 4925 5235
Fax 102283 0
Email 102283 0
corinna.beckmore@bctrials.org.au
Contact person for scientific queries
Name 102284 0
A/Prof Nick Murray
Address 102284 0
Royal Adelaide Hospital
Cancer Clinical Trials (MDP 46)
Level 6E-351
Port Road
ADELAIDE SA 5000
Country 102284 0
Australia
Phone 102284 0
+61 2 4925 5235
Fax 102284 0
Email 102284 0
corinna.beckmore@bctrials.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data Sharing process for this study is in development and will be updated as soon as it is available.
What supporting documents are/will be available?
No other documents available
Summary results
No Results