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Activity of CYP3A and Genotypes of CYP3A5 and MDR1 as Predictors of the Clearance and Adverse Effects of Docetaxel, and the Effect of Docetaxel to CYP3A Activity in Previously Untreated Breast Cancer Patients


N/A
18 Years
60 Years
Not Enrolling
Female
CYP3A Phenotyping, CYP3A5 and MDR1 Genotyping, Docetaxel Toxicity, Associations Between Genetic Data and Docetaxel Toxicity

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Trial Information

Activity of CYP3A and Genotypes of CYP3A5 and MDR1 as Predictors of the Clearance and Adverse Effects of Docetaxel, and the Effect of Docetaxel to CYP3A Activity in Previously Untreated Breast Cancer Patients


Inclusion Criteria:



Subjects may be included in the study only if they meet all of the following criteria:

1. The patient has received information on the purpose of the study and the meaning of
the treatment, and has given verbal and written consent to participate in the study.
The patient is accessible for treatment and follow-up.

2. Histologically verified diagnosis of breast cancer

3. High risk for recurrence ( node positive or node negative if T2 with histological
grade 2 or 3, or Pgr negative)

4. No metastases

5. Females, age =<60

6. No concomitant regular medication which is either substrate, inducer or inhibitor of
CYP3A4

Exclusion Criteria:

Subjects will be excluded from the study for any of the following reasons:

1. Poor performance status,>=2 according to WHO

2. Inadequate bone marrow reserve defined as:

- hemoglobin < 100 g/L

- leukocytes < 3.0 x 10E9/L or neutrophiles < 1.5 x 10E9/L

- plateless < 120 x 10E9/L

3. Inadequate liver function defined as:

- ALAT is > 1.5 x units of normal level

- elevated bilirubin (unless verified GilbertĀ“s syndrome)

- alkaline phosphatase is > 2.5 x units of normal level

4. History of concomitant serious physical or psychiatric disease, which makes a
regular cytotoxic treatment impossible

5. cardiac insufficience; severe arrhythmia; severe hypertension; cardiac infarction
within one year or other active cardiac disease

6. pregnant or lactating patients

7. abuse of alcohol or any narcotic substances

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

docetaxel toxicity

Outcome Description:

There were no specific outcome measures in this study. The chemotherapy was given in a predetermined schedule and additionally blood samples were drawn for genotyping. The adverse events were recorded and compared with the data from genotyping.

Safety Issue:

Yes

Principal Investigator

Johanna Hilli, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Pharmacology, Drug Development and Therapeutics, University of Turku, Turku, Finland

Authority:

Finland: Finnish Medicines Agency

Study ID:

XRP 6976A/6022

NCT ID:

NCT01110291

Start Date:

April 2003

Completion Date:

March 2009

Related Keywords:

  • CYP3A Phenotyping
  • CYP3A5 and MDR1 Genotyping
  • Docetaxel Toxicity
  • Associations Between Genetic Data and Docetaxel Toxicity
  • docetaxel toxicity
  • CYP3A activity
  • CYP3A5
  • MDR1
  • peroral midazolam

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