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Tamoxifen Citrate in Patients With Breast Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2013 by Dr K. Zaman, Centre Hospitalier Universitaire Vaudois.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00963209
First Posted: August 21, 2009
Last Update Posted: August 2, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr K. Zaman, Centre Hospitalier Universitaire Vaudois
  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: None (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 Dr K. Zaman, 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 140
Study Start Date: June 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: September 2013 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: August 20, 2009
First Posted: August 21, 2009
Last Update Posted: August 2, 2013
Last Verified: July 2013

Keywords provided by Dr K. Zaman, 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
Citric Acid
Tamoxifen
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents