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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01075802




Registration number
NCT01075802
Ethics application status
Date submitted
24/02/2010
Date registered
25/02/2010
Date last updated
6/05/2013

Titles & IDs
Public title
Study of Tamoxifen Dose Escalation in Breast Cancer Patients With CYP2D6 Polymorphisms
Scientific title
A Multi-Centre Study of Tamoxifen Dose Escalation Study in Breast Cancer Patients With CYP2D6 Polymorphisms
Secondary ID [1] 0 0
TADE study
Universal Trial Number (UTN)
Trial acronym
TADE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
CYP2D6 Polymorphism 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tamoxifen

Experimental: Tamoxifen - Dose escalation of tamoxifen in patients with low endoxifen levels


Treatment: Drugs: Tamoxifen
Dose escalation
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Effects of genotype of CYP2D on plasma and serum concentration of tamoxifen and its metabolites, with consequent recommendation for dosage adjustment
Timepoint [1] 0 0
dose escalation over 40 weeks
Primary outcome [2] 0 0
To test whether Tamoxifen dose escalation in patients with genetic polymorphism of CYP2D6 will increase endoxifen blood levels to a target level
Timepoint [2] 0 0
Dose escalation over 40 weeks
Primary outcome [3] 0 0
Correlate tamoxifen and its metabolites concentration with tamoxifen side effects
Timepoint [3] 0 0
dose escalation over 40 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2012
Sample size
Target
Accrual to date
Final
121
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
St George Hospital - Sydney
Recruitment hospital [2] 0 0
Westmead Cancer Care Centre - Westmead
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment postcode(s) [2] 0 0
2145 - Westmead

Funding & Sponsors
Primary sponsor type
Other
Name
Western Sydney Local Health District
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
St George Hospital, Australia
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Howard Gurney, MBBS,FRACP
Address 0 0
South West Sydney Local Health District
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01075802