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Tamoxifen Citrate in Patients With Breast Cancer

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.
 
ClinicalTrials.gov Identifier: NCT00963209
Recruitment Status : Unknown
Verified July 2013 by Dr K. Zaman, Centre Hospitalier Universitaire Vaudois.
Recruitment status was:  Recruiting
First Posted : August 21, 2009
Last Update Posted : August 2, 2013
Sponsor:
Information provided by (Responsible Party):
Dr K. Zaman, Centre Hospitalier Universitaire Vaudois

Tracking Information
First Submitted Date  ICMJE August 20, 2009
First Posted Date  ICMJE August 21, 2009
Last Update Posted Date August 2, 2013
Study Start Date  ICMJE June 2009
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2012)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 20, 2009)
Determination of CYP2D6 genotype (*3, *4, *5, *6) 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
Change History Complete list of historical versions of study NCT00963209 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2009)
  • Patients' characteristics: age, body weight and height, ethnic origin
  • Tumor characteristics: TNM classification, size, number of metastatic nodes, grade, vascular invasion or not, HER2 overexpression (by IHC: 3+ vs 0 to 2+) or gene amplification (by FISH: ratio ≥ 2 vs < 2), ER expression (%), PR expression (%)
  • Cancer tx history: surgery (tumorectomy or mastectomy and sentinel node or axillary dissection), adjuvant radiotherapy (yes/no), adjuvant chemotherapy (yes/no; type), adjuvant trastuzumab (yes/no), and endocrine therapy (what; start/end date)
  • CYP3A4 (phenotype by midazolam test), CYP3A5, CYP2C19, SULT1A1, and possibly other cytochromes involved in the metabolism and transport of drugs
  • Characteristics of drug intake (date of tx initiation, current dosage and frequency, time of last intake) along with patient-reported adherence, assessed by questionnaire
  • Concomitant medication during the month before each determination of drug concentration
  • Presence and quantitation of hot flashes/sudations, scored as the average number of hot flashes over the previous days times their average intensity on a 0-3 scale
  • Detection and classification of general comorbidities and side effects according to NCI-CTC v3.0
  • Detection of tumor relapse during the observation period of the study
  • Other analysis may be conducted exclusively limited to the pharmacology of tamoxifen citrate
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tamoxifen Citrate in Patients With Breast Cancer
Official Title  ICMJE Tamoxifen Metabolism and the Impact of Tamoxifen Dose on the Level of the Active Metabolites in Endocrine Sensitive Breast Cancer Patients
Brief 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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: tamoxifen citrate
  • Other: laboratory biomarker analysis
  • Other: pharmacological study
Study Arms  ICMJE Experimental: Tamoxifen
Interventions:
  • Drug: tamoxifen citrate
  • Other: laboratory biomarker analysis
  • Other: pharmacological study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 20, 2009)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2013
Estimated Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00963209
Other Study ID Numbers  ICMJE CDR0000650376
CHUV-CEPO-TM
EU-20973
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr K. Zaman, Centre Hospitalier Universitaire Vaudois
Study Sponsor  ICMJE Centre Hospitalier Universitaire Vaudois
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Khalil Zaman, MD Centre Hospitalier Universitaire Vaudois
PRS Account Centre Hospitalier Universitaire Vaudois
Verification Date July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP