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Genetic Study of CYP2D6 Enzyme and Therapeutic Drug Monitoring of Tamoxifen

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ClinicalTrials.gov Identifier: NCT03582865
Recruitment Status : Not yet recruiting
First Posted : July 11, 2018
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Amira Fawzy Taha, Assiut University

Brief Summary:

Aim of work:

  1. To estimate the frequency of Cyp2D6*1 and *4 alleles in Egyptian patients maintained on tamoxifen (20 mg/day) for management of ER +ve breast cancer.
  2. To measure levels of tamoxifen, 4-hydroxy tamoxifen, N-desmethyl-tamoxifen and 4- hydroxyl-N-desmethyl-tamoxifen (endoxifen) in the serum of these patients.
  3. To correlate between the levels of tamoxifen/active metabolite enoxifen ratio and CYP2D6*1,*4 genotyping.
  4. To investigate which is more valuable investigatory tool for prediction of the clinical outcome (response and/or toxicity) in these patients; either the measurements related to pharmacokinetics: tamoxifen/endoxifen levels or the pharmacogenetic analysis of CYP2D6 *1,*4.

Condition or disease Intervention/treatment
Breast Cancer Drug: Tamoxifen 20 mg

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genetic Study of CYP2D6 Enzyme and Therapeutic Drug Monitoring of Tamoxifen in Premenopausal Women With Breast Cancer
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
responding
patients who received Tamoxifen 20 mg daily for at least 3 years with good response (no relapse) to tamoxifen. Both genotyping assessment and TDM of tamoxifen and its metabolites will be performed and correlated with the records. Follow up for these patients for further assessment of tamoxifen effectiveness will be carried out for 1- 2 years.
Drug: Tamoxifen 20 mg
Tamoxifen 20 mg is a selective estrogen receptor modulator
Other Name: Genetic

relapse
patients who received Tamoxifen 20 mg daily for at least 3 years who were good responder to the drug but then the response has been diminished (relapse) and they have been shifted to another therapy. They will be exposed to genotyping study of CYP 2D6 to recognize the phenotyping style of that patient that may explain diminishing of response to tamoxifen therapy.
Drug: Tamoxifen 20 mg
Tamoxifen 20 mg is a selective estrogen receptor modulator
Other Name: Genetic

tamoxifen resistant
patients who received Tamoxifen 20 mg daily for not more than 1 year with poor response to tamoxifen (early relapse) and clinically will be shifted to use another medication as they were diagnosed as tamoxifen resistant. Like the second group, they will be exposed to genotyping study of CYP2D6 with the same concept.
Drug: Tamoxifen 20 mg
Tamoxifen 20 mg is a selective estrogen receptor modulator
Other Name: Genetic




Primary Outcome Measures :
  1. Estimate the frequency of Cyp2D6*1 and *4 alleles in Egyptian patients maintained on tamoxifen (20 mg/day) for management of ER +ve breast cancer. [ Time Frame: 6 months ]
    The CYP2D6 genotypes will be determined using the TaqMan Allelic Discrimination Assay.


Secondary Outcome Measures :
  1. measuring levels of tamoxifen, 4-hydroxy tamoxifen, N-desmethyl-tamoxifen and 4- hydroxyl-N-desmethyl-tamoxifen (endoxifen) in the serum ofbreast cancer patients. [ Time Frame: 2 months ]
    Plasma concentrations of tamoxifen, 4-hydroxy-tamoxifen (4-OH-tam), N-desmethyl-tamoxifen (N-DM-tam) and 4-hydroxy-N-desmethyl-tamoxifen (endoxifen) will be measured using sensitive HPLC-PDA assay method.



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Premenopausal women suffering from breast cancer
Criteria

Inclusion Criteria:

  • Premenopausal patients will be included in this study, with hormone receptor positive tumors.
  • The hormone receptor positive tumor is diagnosed by microscopic examination if ≥ 10% of the cells are positive for estrogen by immunohistochemistry analysis.
  • All patients with normal hepatic and renal function, aspartate aminotransferase and alanine aminotransferase (≤2 upper normal limit) and serum creatinine (≤1.2 mg/dl).

Exclusion Criteria:

  • Patients treated with other hormonal therapy, radiation or chemotherapy will be excluded from the study.
  • Pregnant or breast feeding women will be excluded from the study.
  • Patients who are taking drugs that are known to inhibit CYP2D6 activity as SSRIs will be excluded from the study.

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): NCT03582865


Contacts
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Contact: Amira Taha +201003606486 dr_amira.fawzy88@hotmail.com

Sponsors and Collaborators
Assiut University
Investigators
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Principal Investigator: Amira Taha Assiut University
Study Director: Ehab Eldesoky Assiut University
Study Director: Mohammad Hareedy Assiut University

Publications:

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Responsible Party: Amira Fawzy Taha, Assistant Lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT03582865     History of Changes
Other Study ID Numbers: Genetic study and TDM
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amira Fawzy Taha, Assiut University:
Breast cancer
Genotyping
Tamoxifen
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
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