Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
140 participants
INTERVENTIONAL
2009-06-30
2013-12-31
Brief Summary
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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
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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
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Tamoxifen
tamoxifen citrate
laboratory biomarker analysis
pharmacological study
Interventions
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tamoxifen citrate
laboratory biomarker analysis
pharmacological study
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire Vaudois
OTHER
Responsible Party
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Dr K. Zaman
Médecin associé
Principal Investigators
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Khalil Zaman, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire Vaudois
Locations
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Hôpitaux Universitaire de Genève
Geneva, , Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Countries
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Facility Contacts
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Alexandre Bodmer, MD
Role: primary
Khalil Zaman, MD
Role: primary
Other Identifiers
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CHUV-CEPO-TM
Identifier Type: -
Identifier Source: secondary_id
EU-20973
Identifier Type: -
Identifier Source: secondary_id
CDR0000650376
Identifier Type: -
Identifier Source: org_study_id