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Trial registered on ANZCTR


Registration number
ACTRN12610000045011
Ethics application status
Approved
Date submitted
12/01/2010
Date registered
15/01/2010
Date last updated
15/01/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Inter-ethnic differences in tolerance of anti-cancer drugs in breast cancer patients
Scientific title
Exploration of differences in tolerance of anthracycline-based chemotherapy between Caucasian and Asian breast cancer patients
Secondary ID [1] 1272 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
tolerance of adjuvant anthracycline-based chemotherapy in breast cancer patients 256510 0
Condition category
Condition code
Cancer 256677 256677 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observe side effects, nutritional status and measure drug clearance of the cycle 1 treatment (21 days):
FEC regimen: epirubicin, 5-fluorouracil (5-FU), cyclophosphamide.
AC regimen: doxorubicin, cyclophosphamide.
EC: epirubicin, cyclophosphamide
Collect Deoxyribonucleic acid (DNA) samples for pharmacogenomics purpose
Intervention code [1] 255789 0
Not applicable
Comparator / control treatment
Compare side effects and drug clearance between Caucasian and Asian patients
Control group
Active

Outcomes
Primary outcome [1] 257565 0
adverse events of the treatment including hematological toxicity, and other toxicity such as nausea, vomiting, diarrhoea, fatigue and mucositis according to common terminology criteria for adverse event v3.0(CTCAE)
Timepoint [1] 257565 0
3 weeks during cycle 1 at day 7, day 10 , day 14 and day 21 of cycle 1
Secondary outcome [1] 262811 0
rate of drug clearance measured by using population pharmacokinetics approach with limited sampling model
Timepoint [1] 262811 0
day 0 and day 1 of cycle 1
Secondary outcome [2] 262812 0
single nucleotide polymorphism of gene coding drug metabolizing enzymes measured by rapid throughput genotyping being preformed using high-resolution melt-curve analysis
Timepoint [2] 262812 0
before start of chemotherapy
Secondary outcome [3] 262826 0
nutritional status measured by patient-generated subjective global assessment (PGSGA)
Timepoint [3] 262826 0
before start of chemotherapy

Eligibility
Key inclusion criteria
- Asian or Caucasian patients.
- Histologically confirmed breast cancer.
- Women with non-metastatic breast cancer for whom adjuvant chemotherapy with AC or EC or FEC is appropriate
- Age greater than or equal to 18.
- Eastern Cooperative Oncology Group (ECOG)Performance Status of 0-2.
- Ability to comply with the planned procedures and provide written evidence of informed consent.
- Adequate haematology and biochemistry. (Haemoglobin>100 g/L, White blood cell count >4.0 x 109/L, neutrophil count > 1.5 × 109, platelets >100 x 109/L; Aspartate transaminase (AST), Alanine transaminase (ALT) and bilirubin < 1.5 x ULN (AST, ALT < 5 x upper limit of normal in case liver metastases); calculated creatinine clearance according to Corkroft formula > 60 ml/min.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients who require dose adjustment.
- Clinical evidence of brain metastases.
- Suspected or documented bone marrow involvement.
- Significant intercurrent illness including active infection, inflammatory bowel disease or other uncontrolled autoimmune disease.
- The requirement for ongoing systemic treatment with corticosteroids or other immunosuppressive therapy.
- Patients who have had chemotherapy 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
- Ongoing major side effects from radiology.
- Other active malignancy.
- Known allergy to any of the investigational agents.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
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)
Recruitment postcode(s) [1] 2382 0
2139
Recruitment outside Australia
Country [1] 1881 0
China
State/province [1] 1881 0
Shanghai

Funding & Sponsors
Funding source category [1] 256274 0
Government body
Name [1] 256274 0
National Health and Medical Research Council, Australia
Address [1] 256274 0
National Health and Medical Research Council
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 256274 0
Australia
Primary sponsor type
Hospital
Name
Sydney Cancer Centre
Address
Sydney Cancer Centre,
Concord Hospital, Hospital road
Concord NSW 2139
Country
Australia
Secondary sponsor category [1] 251603 0
University
Name [1] 251603 0
The University of Sydney
Address [1] 251603 0
Faculty of Medicine,
The University of Sydney,
NSW 2006
Country [1] 251603 0
Australia
Other collaborator category [1] 1020 0
Hospital
Name [1] 1020 0
Renji Hospital, Shanghai
Address [1] 1020 0
Oncology Department, Renji Hospital,
1630 Dongfang road, Pudong 200122
Shanghai
Country [1] 1020 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258366 0
Human Research Ethics Committee-Concord Repatriation General Hospital Zone
Ethics committee address [1] 258366 0
Sydney South West Area Health Service
Human Research Ethics Committee-CRGH Zone
Concord Repatriation General Hospital
Hospital road
Concord NSW 2139
Ethics committee country [1] 258366 0
Australia
Date submitted for ethics approval [1] 258366 0
Approval date [1] 258366 0
26/10/2006
Ethics approval number [1] 258366 0
CH62/6/2006-092
Ethics committee name [2] 258367 0
Human Research Ethics Committee
Ethics committee address [2] 258367 0
Sydney South West Area Health Service
Human Research Ethics Committee-RPAH zone
Royal Prince Alfred Hospital,
Missenden road
Camperdown NSW 2050
Ethics committee country [2] 258367 0
Australia
Date submitted for ethics approval [2] 258367 0
Approval date [2] 258367 0
01/12/2006
Ethics approval number [2] 258367 0
X06-0298

Summary
Brief summary
Recent evidence shows an ethnic variability in tolerance of anticancer drugs between Asian and Caucasian breast cancer patients. Pharmacogenetic differences in drug metabolising enzymes have been proposed as the cause of these differences, however they have not been associated with altered cytotoxic drug pharmacokinetics (PK). Other possible explanations include differences in dietary/concomitant medicine intake and inflammatory status. The aim of this study was to investigate inter-ethnic differences in cytotoxic drug metabolism, inflammatory/nutritional status, genotype and outcomes between Asian and Caucasian breast cancer patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29894 0
Address 29894 0
Country 29894 0
Phone 29894 0
Fax 29894 0
Email 29894 0
Contact person for public queries
Name 13141 0
Prof. Stephen Clarke
Address 13141 0
Sydney Cancer Centre,
Concord Hospital, Hospital road
Concord, NSW 2139
Country 13141 0
Australia
Phone 13141 0
+ 61 2 97676775
Fax 13141 0
Email 13141 0
stephen.clarke@usyd.edu.au
Contact person for scientific queries
Name 4069 0
Prof. Stephen Clarke
Address 4069 0
Sydney Cancer Centre,
Concord Hospital, Hospital road
Concord, NSW 2139
Country 4069 0
Australia
Phone 4069 0
+61 2 97676775
Fax 4069 0
Email 4069 0
stephen.clarke@usyd.edu.au

No information has been provided regarding IPD availability
Summary results
No Results