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

Not Applicable

Recruiting

• Conditions: tolerance of adjuvant anthracycline-based chemotherapy in breast cancer patients; Cancer - Breast

• Registration Number: ACTRN12610000045011
• Lead Sponsor: Sydney Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-01-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 120

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)[3 weeks during cycle 1 at day 7, day 10 , day 14 and day 21 of cycle 1]

Secondary Outcome Measures

Name	Time	Method
rate of drug clearance measured by using population pharmacokinetics approach with limited sampling model[day 0 and day 1 of cycle 1];single nucleotide polymorphism of gene coding drug metabolizing enzymes measured by rapid throughput genotyping being preformed using high-resolution melt-curve analysis[before start of chemotherapy];nutritional status measured by patient-generated subjective global assessment (PGSGA)[before start of chemotherapy]