Inter-ethnic differences in tolerance of anti-cancer drugs in breast cancer patients

Exploration of differences in tolerance of anthracycline-based chemotherapy between Caucasian and Asian breast cancer patients

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12610000045011

Enrollment

120

Registered

2010-01-15

Start date

2007-01-24

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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.

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.

Outcome results