RecruitingACTRN12610000045011

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


Sponsor

Sydney Cancer Centre

Enrollment

120 participants

Start Date

Jan 24, 2007

Study Type

Observational

Conditions

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.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at whether Asian and Caucasian women with breast cancer respond differently to chemotherapy drugs. Some research suggests that Asian women may experience more side effects from certain cancer medicines than Caucasian women, possibly due to genetic differences in how the body breaks down these drugs. This study will measure drug levels in the blood and look at genetic factors and nutrition to understand these differences. You may be eligible if: - You are a woman aged 18 or older - You are of Asian or Caucasian background - You have confirmed breast cancer (not spread to other organs) for which chemotherapy with AC, EC, or FEC regimens is recommended - Your blood counts and organ function are within acceptable ranges You may NOT be eligible if: - You need a dose adjustment from the standard chemotherapy dose - You have brain metastases (cancer that has spread to the brain) - You have active infection, inflammatory bowel disease, or an uncontrolled autoimmune condition - You have another active cancer - You are allergic to any of the study drugs Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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, cy

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


Locations(1)

Shanghai, China

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ACTRN12610000045011