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A Multi-Centre Study of Tamoxifen Dose Escalation Study in Breast Cancer Patients With CYP2D6 Polymorphisms


N/A
18 Years
N/A
Not Enrolling
Both
Breast Cancer, CYP2D6 Polymorphism

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Trial Information

A Multi-Centre Study of Tamoxifen Dose Escalation Study in Breast Cancer Patients With CYP2D6 Polymorphisms


Inclusion Criteria:



- ECOG performance status ≤ 1

- Life expectancy ≥ 6 months

- Histologically or cytologically confirmed early, locally advanced or metastatic
breast cancer

- Oestrogen receptor positive

- About to start tamoxifen treatment or already on tamoxifen 20mg daily

- Adequate hepatic and renal function

Exclusion Criteria:

- Concurrent chemotherapy or radiotherapy

- Treatment with medications that may alter cytochrome P450 (CYP450)3A4/5 and CYP2D6
activities

- History of thrombosis

- History of non-compliance with previous or current treatment;

- Medical or psychiatric conditions that compromise the patient's ability to give
informed consent

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Effects of genotype of CYP2D on plasma and serum concentration of tamoxifen and its metabolites, with consequent recommendation for dosage adjustment

Outcome Time Frame:

dose escalation over 40 weeks

Safety Issue:

No

Principal Investigator

Howard Gurney, MBBS,FRACP

Investigator Role:

Principal Investigator

Investigator Affiliation:

South West Sydney Local Health District

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

TADE study

NCT ID:

NCT01075802

Start Date:

March 2010

Completion Date:

December 2012

Related Keywords:

  • Breast Cancer
  • CYP2D6 Polymorphism
  • Breast cancer
  • Tamoxifen
  • Endoxifen
  • polymorphism of CYP2D6
  • Breast Neoplasms

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