Breast CancerPhase 3NCT00963209
Tamoxifen Citrate in Patients With Breast Cancer
A Phase 3 study testing tamoxifen citrate, laboratory biomarker analysis and pharmacological study in people with Breast Cancer, run by Centre Hospitalier Universitaire Vaudois at 2 sites in Switzerland.
Trial summary
RATIONALE: Estrogen can promote growth of endocrine sensitive breast cancer cells. Endocrine therapy with tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells. Pharmacokinetics and -genomics can have an impact on the efficacy of the treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- tamoxifen citrate, laboratory biomarker analysis and pharmacological study
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Jun 2009to Dec 2013
- Phase
- Phase 3
- 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
DISEASE CHARACTERISTICS:
- Diagnosis of breast cancer
- Hormone-sensitive breast cancer defined as > 10% estrogen receptor and/or > 10% progesterone receptor positivity by immunohistochemistry
- Receiving treatment with tamoxifen citrate and must be eligible for exposure to higher doses
PATIENT CHARACTERISTICS:
- No history of deep venous thrombosis or pulmonary embolism
- No history of endometrial carcinoma
- No known history of vaginal bleeding, endometriosis, endometrial hyperplasia, endometrial hypertrophy, and/or polyps
- Not pregnant or nursing
- No contraindication to tamoxifen citrate treatment
- No known allergy to midazolam or dextromethorphan
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites, 2 recruiting
- Recruiting
Hôpitaux Universitaire de Genève
Geneva, 1211
Alexandre Bodmer, MD, 41 22 382 40 14
- Recruiting
Centre Hospitalier Universitaire Vaudois
Lausanne, 1011
Khalil Zaman, MD, 41-21-314-0168, Khalil.Zaman@chuv.ch
About this study
Official title: Tamoxifen Metabolism and the Impact of Tamoxifen Dose on the Level of the Active Metabolites in Endocrine Sensitive Breast Cancer Patients
RATIONALE: Estrogen can promote growth of endocrine sensitive breast cancer cells. Endocrine therapy with tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells. Pharmacokinetics and -genomics can have an impact on the efficacy of the treatment.
PURPOSE: This phase III trial is studying blood samples to see if the level of active metabolites of tamoxifen can be improved in patients with breast cancer.
Read the detailed description
OBJECTIVES:
Primary
- To determine how the increase of tamoxifen citrate dose influences the level of its major metabolites in patients with hormone-sensitive breast cancer.
Secondary
- To characterize the population pharmacokinetic profile
- To investigate the role of the other CYPs
- To assess the relation between clinical symptoms and CYP2D6 genotypes and/or active metabolites levels
- To explore the correlation between genotypes/metabolites levels and clinical outcomes in terms of tumor relapse.
- To assess the feasibility, efficacy, and safety of concentration-guided adjustment of tamoxifen citrate dosage.
- To conduct other exploratory analysis based on the eventual new data coming up in the future.
OUTLINE: Patients receive oral tamoxifen citrate (at a dose of 40 mg/day) daily for 4 months in the absence of disease progression or unacceptable toxicity.
Blood samples are collected for PK, genotyping, phenotyping, and further analysis.
- Conditions
- Breast Cancer
- Being tested
- tamoxifen citrate, laboratory biomarker analysis, pharmacological study
- Keywords
- endocrine sensitive, breast cancer, tamoxifen, genotyping, phenotyping, Pharmacokinetics, Endoxifen
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tamoxifen citrateDrug
laboratory biomarker analysisOther
| Study group | Role | What they receive |
|---|---|---|
| Tamoxifen | Experimental | Not described Receives: Drug: tamoxifen citrate; Other: laboratory biomarker analysis; Other: pharmacological study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of CYP2D6 genotype and determination of plasma concentrations of tamoxifen citrate and its metabolites (N-desmethyl-tamoxifen, 4-hydroxy-tamoxifen and endoxifen) under the 20 mg daily and 40 mg daily schedules
Measured: Jan 2013
Secondary outcomes (9)
Patients' characteristics
Measured: prospectively
Tumor characteristics
Measured: prospectively
Cancer treatments history
Measured: prospectively
CYP3A4 (phenotype), and possibly other cytochromes involved in the metabolism and transport of drugs
Measured: prospectively
Characteristics of drug intake (date of tx initiation, current dosage and frequency, time of last intake) along with patient-reported adherence, assessed by questionnaire
Measured: prospectively
Concomitant medication
Measured: prospectively
Presence and quantitation of clinical symptoms
Measured: prospectively
Detection and classification of general comorbidities and side effects according to NCI-CTC v3.0
Measured: prospectively
Detection of tumor relapse during the observation period of the study
Measured: prospectively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2009 (estimated)
- Study startJun 2009
- Primary completionSep 2013 (estimated)
- Study completionDec 2013 (estimated)
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.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr K. Zaman, Centre Hospitalier Universitaire Vaudois
- Investigators
- Khalil Zaman, MD, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963209
- Sponsor's protocol ID
- CDR0000650376
- Other IDs
- CHUV-CEPO-TM, EU-20973
- Status last verified
- Jul 2013
- First submitted
- 20 Aug 2009
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tamoxifen Metabolism and the Impact of Tamoxifen Dose on the Level of the Active Metabolites in Endocrine Sensitive Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00963209
- Acronym / sponsor ID
- CDR0000650376
- Conditions
- Breast Cancer
- Keywords
- endocrine sensitive, breast cancer, tamoxifen, genotyping, phenotyping, Pharmacokinetics, Endoxifen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 21 Aug 2009 (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.
RATIONALE: Estrogen can promote growth of endocrine sensitive breast cancer cells. Endocrine therapy with tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells. Pharmacokinetics and -genomics can have an impact on the efficacy of the treatment.
PURPOSE: This phase III trial is studying blood samples to see if the level of active metabolites of tamoxifen can be improved in patients with breast cancer.
Detailed description
OBJECTIVES:
Primary
- To determine how the increase of tamoxifen citrate dose influences the level of its major metabolites in patients with hormone-sensitive breast cancer.
Secondary
- To characterize the population pharmacokinetic profile
- To investigate the role of the other CYPs
- To assess the relation between clinical symptoms and CYP2D6 genotypes and/or active metabolites levels
- To explore the correlation between genotypes/metabolites levels and clinical outcomes in terms of tumor relapse.
- To assess the feasibility, efficacy, and safety of concentration-guided adjustment of tamoxifen citrate dosage.
- To conduct other exploratory analysis based on the eventual new data coming up in the future.
OUTLINE: Patients receive oral tamoxifen citrate (at a dose of 40 mg/day) daily for 4 months in the absence of disease progression or unacceptable toxicity.
Blood samples are collected for PK, genotyping, phenotyping, and further analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tamoxifen | Experimental | Drug: tamoxifen citrate, Other: laboratory biomarker analysis, Other: pharmacological study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| tamoxifen citrate | Drug | Tamoxifen |
| laboratory biomarker analysis | Other | Tamoxifen |
| pharmacological study | Other | Tamoxifen |
Primary outcome
Determination of CYP2D6 genotype and determination of plasma concentrations of tamoxifen citrate and its metabolites (N-desmethyl-tamoxifen, 4-hydroxy-tamoxifen and endoxifen) under the 20 mg daily and 40 mg daily schedules
Time frame: Jan 2013
9 secondary outcomes
Patients' characteristics
Time frame: prospectively
Tumor characteristics
Time frame: prospectively
Cancer treatments history
Time frame: prospectively
CYP3A4 (phenotype), and possibly other cytochromes involved in the metabolism and transport of drugs
Time frame: prospectively
Characteristics of drug intake (date of tx initiation, current dosage and frequency, time of last intake) along with patient-reported adherence, assessed by questionnaire
Time frame: prospectively
Concomitant medication
Time frame: prospectively
Presence and quantitation of clinical symptoms
Time frame: prospectively
Detection and classification of general comorbidities and side effects according to NCI-CTC v3.0
Time frame: prospectively
Detection of tumor relapse during the observation period of the study
Time frame: prospectively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 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.
Khalil Zaman, MD principal investigator
Centre Hospitalier Universitaire Vaudois
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tamoxifen citrate, laboratory biomarker analysis and pharmacological study in people with Breast Cancer, run by Centre Hospitalier Universitaire Vaudois at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 2 Aug 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 Switzerland. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of CYP2D6 genotype and determination of plasma concentrations of tamoxifen citrate and its metabolites (N-desmethyl-tamoxifen, 4-hydroxy-tamoxifen and endoxifen) under the 20 mg daily and 40 mg daily schedules (time frame: Jan 2013). 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 2 Aug 2013.