Breast CancerTADENCT01075802
Study of Tamoxifen Dose Escalation in Breast Cancer Patients With CYP2D6 Polymorphisms
A study testing Tamoxifen in people with Breast Cancer and CYP2D6 Polymorphism, run by Western Sydney Local Health District at 2 sites in Australia.
Trial summary
Tamoxifen is an important drug for the treatment of breast cancer. Used adjuvantly after operation in early breast cancer, tamoxifen reduces annual recurrence rate by half and cancer death by one third. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, CYP2D6 Polymorphism
- What is being tested?
- Tamoxifen
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 2 sitesAustralia
- Study dates
- Mar 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
St George Hospital
Sydney, New South Wales
Westmead Cancer Care Centre
Westmead, New South Wales, 2145
About this study
Official title: A Multi-Centre Study of Tamoxifen Dose Escalation Study in Breast Cancer Patients With CYP2D6 Polymorphisms
Tamoxifen is an important drug for the treatment of breast cancer. Used adjuvantly after operation in early breast cancer, tamoxifen reduces annual recurrence rate by half and cancer death by one third. Used preventatively it also reduces the risk of breast cancer by 50% in women at high risk for developing the disease Tamoxifen needs to be activated in the body to an active form called endoxifen, mainly by the enzyme called CYP2D6. Patients have variable capability to activate tamoxifen due to variable function of this enzyme. Studies showed clear correlation of specific genetic variant of CYP2D6 with endoxifen blood levels. It is estimated that up to 25% Caucasian population have reduced or even absent CYP2D6 function. More recently, there were studies that showed the correlation with genetic variant of CYP2D6 and breast cancer relapse in early breast cancer patients treated with tamoxifen. Food and Drug Authority (FDA) in America and recommended checking CYP2D6 genotype in patients receiving tamoxifen treatment, but they did not specify how to interpret the genotype results and what kind actions to take in patient with adverse genotype. The aim of the investigators study is to see if increasing tamoxifen in patients with genetic polymorphism of CYP2D6 will increase endoxifen level to the same range of most patients who have wild type (normal functional)CYP2D6.
- Conditions
- Breast Cancer, CYP2D6 Polymorphism
- Being tested
- Tamoxifen
- Keywords
- Breast cancer, Tamoxifen, Endoxifen, polymorphism of CYP2D6
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamoxifenDrug
Dose escalation
| Study group | Role | What they receive |
|---|---|---|
| Tamoxifen | Experimental | Dose escalation of tamoxifen in patients with low endoxifen levels Receives: Drug: Tamoxifen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of genotype of CYP2D on plasma and serum concentration of tamoxifen and its metabolites, with consequent recommendation for dosage adjustment
Measured: dose escalation over 40 weeks
To test whether Tamoxifen dose escalation in patients with genetic polymorphism of CYP2D6 will increase endoxifen blood levels to a target level
Measured: Dose escalation over 40 weeks
Correlate tamoxifen and its metabolites concentration with tamoxifen side effects
Measured: dose escalation over 40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionOct 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Sydney Local Health District
- Sponsor type
- University, hospital or other
- Collaborators
- St George Hospital, Australia
- Responsible party
- Principal investigator, Howard Gurney, Western Sydney Local Health District
- Investigators
- Howard Gurney, MBBS,FRACP, Principal investigator, South West Sydney Local Health District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01075802
- Sponsor's protocol ID
- TADE study
- Acronym
- TADE
- Status last verified
- May 2013
- First submitted
- 24 Feb 2010
- Last updated
- 6 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre Study of Tamoxifen Dose Escalation Study in Breast Cancer Patients With CYP2D6 Polymorphisms
- ClinicalTrials.gov ID
- NCT01075802
- Acronym / sponsor ID
- TADE / TADE study
- Conditions
- Breast Cancer, CYP2D6 Polymorphism
- Keywords
- Breast cancer, Tamoxifen, Endoxifen, polymorphism of CYP2D6
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Western Sydney Local Health DistrictUniversity, hospital or other
- Collaborators
- St George Hospital, Australia
- Study start
- Mar 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 25 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tamoxifen is an important drug for the treatment of breast cancer. Used adjuvantly after operation in early breast cancer, tamoxifen reduces annual recurrence rate by half and cancer death by one third. Used preventatively it also reduces the risk of breast cancer by 50% in women at high risk for developing the disease Tamoxifen needs to be activated in the body to an active form called endoxifen, mainly by the enzyme called CYP2D6. Patients have variable capability to activate tamoxifen due to variable function of this enzyme. Studies showed clear correlation of specific genetic variant of CYP2D6 with endoxifen blood levels. It is estimated that up to 25% Caucasian population have reduced or even absent CYP2D6 function. More recently, there were studies that showed the correlation with genetic variant of CYP2D6 and breast cancer relapse in early breast cancer patients treated with tamoxifen. Food and Drug Authority (FDA) in America and recommended checking CYP2D6 genotype in patients receiving tamoxifen treatment, but they did not specify how to interpret the genotype results and what kind actions to take in patient with adverse genotype. The aim of the investigators study is to see if increasing tamoxifen in patients with genetic polymorphism of CYP2D6 will increase endoxifen level to the same range of most patients who have wild type (normal functional)CYP2D6.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tamoxifen | Experimental | Drug: TamoxifenDose escalation of tamoxifen in patients with low endoxifen levels |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TamoxifenDose escalation | Drug | Tamoxifen |
Primary outcome
Effects of genotype of CYP2D on plasma and serum concentration of tamoxifen and its metabolites, with consequent recommendation for dosage adjustment
Time frame: dose escalation over 40 weeks
To test whether Tamoxifen dose escalation in patients with genetic polymorphism of CYP2D6 will increase endoxifen blood levels to a target level
Time frame: Dose escalation over 40 weeks
Correlate tamoxifen and its metabolites concentration with tamoxifen side effects
Time frame: dose escalation over 40 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Howard Gurney, MBBS,FRACP principal investigator
South West Sydney Local Health District
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tamoxifen in people with Breast Cancer and CYP2D6 Polymorphism, run by Western Sydney Local Health District at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of genotype of CYP2D on plasma and serum concentration of tamoxifen and its metabolites, with consequent recommendation for dosage adjustment (time frame: dose escalation over 40 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2013.