Tamoxifen Citrate in Patients With Breast Cancer
This study is currently recruiting participants.
Verified August 2012 by Centre Hospitalier Universitaire Vaudois
Sponsor:
Centre Hospitalier Universitaire Vaudois
Information provided by (Responsible Party):
Dr K. Zaman, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier:
NCT00963209
First received: August 20, 2009
Last updated: August 8, 2012
Last verified: August 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: tamoxifen citrate Other: laboratory biomarker analysis Other: pharmacological study |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Tamoxifen Metabolism and the Impact of Tamoxifen Dose on the Level of the Active Metabolites in Endocrine Sensitive Breast Cancer Patients |
Resource links provided by NLM:
Further study details as provided by Centre Hospitalier Universitaire Vaudois:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Patients' characteristics [ Time Frame: prospectively ] [ Designated as safety issue: No ]
- Tumor characteristics [ Time Frame: prospectively ] [ Designated as safety issue: No ]
- Cancer treatments history [ Time Frame: prospectively ] [ Designated as safety issue: No ]
- CYP3A4 (phenotype), and possibly other cytochromes involved in the metabolism and transport of drugs [ Time Frame: prospectively ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Concomitant medication [ Time Frame: prospectively ] [ Designated as safety issue: No ]
- Presence and quantitation of clinical symptoms [ Time Frame: prospectively ] [ Designated as safety issue: No ]
- Detection and classification of general comorbidities and side effects according to NCI-CTC v3.0 [ Time Frame: prospectively ] [ Designated as safety issue: Yes ]
- Detection of tumor relapse during the observation period of the study [ Time Frame: prospectively ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 140 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Tamoxifen | Drug: tamoxifen citrate Other: laboratory biomarker analysis Other: pharmacological study |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00963209
Locations
| Switzerland | |
| Hôpitaux Universitaire de Genève | Recruiting |
| Genève, Switzerland, 1211 | |
| Contact: Alexandre Bodmer, MD 41 22 382 40 14 | |
| Centre Hospitalier Universitaire Vaudois | Recruiting |
| Lausanne, Switzerland, 1011 | |
| Contact: Khalil Zaman, MD 41-21-314-0168 Khalil.Zaman@chuv.ch | |
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
Investigators
| Principal Investigator: | Khalil Zaman, MD | Centre Hospitalier Universitaire Vaudois |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr K. Zaman, Médecin associé, Centre Hospitalier Universitaire Vaudois |
| ClinicalTrials.gov Identifier: | NCT00963209 History of Changes |
| Other Study ID Numbers: | CDR0000650376, CHUV-CEPO-TM, EU-20973 |
| Study First Received: | August 20, 2009 |
| Last Updated: | August 8, 2012 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by Centre Hospitalier Universitaire Vaudois:
|
endocrine sensitive breast cancer tamoxifen genotyping |
phenotyping Pharmacokinetics Endoxifen |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Tamoxifen Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents Estrogen Antagonists |
ClinicalTrials.gov processed this record on May 19, 2013