Tamoxifen in Women With Breast Cancer and in Women at High-Risk of Breast Cancer Who Are Receiving Venlafaxine, Citalopram, Escitalopram, Gabapentin, or Sertraline

NCT00667121 | Completed DMC

• 3 other identifiers: MC073807-006133NCI-2011-00406
• Study Type: observational
• Target: 88
• Locations: 1 country
• Sites: 6

Brief Summary

RATIONALE: Studying samples of blood in the laboratory from patients receiving tamoxifen may help doctors learn more about the effects of other drugs on the level of tamoxifen in the blood. PURPOSE: This clinical trial is studying levels of tamoxifen in the blood of women with breast cancer and in women at high risk of breast cancer who are receiving tamoxifen together with venlafaxine, citalopram, escitalopram, gabapentin, or sertraline.

Conditions

Breast Cancer; Depression; Hot Flashes; Psychosocial Effects of Cancer and Its Treatment

Keywords

psychosocial effects of cancer and its treatment; breast cancer; hot flashes; depression

Outcome Measures

Primary Outcomes (1)

• Percent change in plasma concentrations of 4-hydroxy tamoxifen and of endoxifen after ≥ 8 weeks of concurrent administration of tamoxifen citrate and a CYP2D6 inhibitor

  Between 8-16 weeks

Interventions

citalopram hydrobromide DRUG

escitalopram oxalate DRUG

gabapentin DRUG

sertraline hydrochloride DRUG

tamoxifen citrate DRUG

venlafaxine DRUG

molecular genetic technique GENETIC

high performance liquid chromatography OTHER

laboratory biomarker analysis OTHER

pharmacological study OTHER

adjuvant therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

PATIENT CHARACTERISTICS: * Menopausal status not specified * Life expectancy ≥ 16 weeks * No contraindication for venlafaxine, citalopram hydrobromide, escitalopram oxalate, gabapentin, or sertraline hydrochloride PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 4 weeks since prior and no concurrent medications that are known to inhibit the CYP2D6 system

You may qualify if:

• Prescribed tamoxifen either for the prevention or treatment of non-invasive or invasive breast cancer.
• Tamoxifen use \> 4 weeks without any breaks at a dose of 20 mg/day prior to registration
• to begin medical therapy with one of the following drugs: venlafaxine, citalopram, escitalopram, sertraline or gabapentin as determined by their physician
• Agree to continue tamoxifen during the proposed minimum study period of 8 weeks
• Willing to avoid known inhibitors of the CYP2D6 system for duration of study
• Ability to provide informed consent
• Willing to return to primary site of enrollment for follow-up
• Life expectancy \>= 16 weeks
• Agree to provide a blood specimen at the time of pre-treatment (baseline) and at follow-up

You may not qualify if:

• Contraindication to the use of venlafaxine, citalopram, escitalopram, gabapentin or sertraline.
• Use of medications that are known to inhibit the CYP2D6 system within 3 weeks of registration. (see appendix II for list)
• Known to be a CYP2D6 poor metabolizer (defined as homozygous for one of the following CYP2D6 null alleles: \*3, \*4, \*5, \*6).
• Note: CYP2D6 genotyping is not required prior to enrollment; however, CYP2D6 genotyping will be performed at baseline and the treating physician will be notified of the results: all genotypic CYP2D6 PM will be replaced

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (6)

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202-5289, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-0942, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599, United States

Location

Virginia Cancer Specialists PC-Arlington

Arlington, Virginia, 22205, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms; Depression; Hot Flashes

Interventions

Citalopram; Escitalopram; Gabapentin; Sertraline; Tamoxifen; Venlafaxine Hydrochloride; Genetic Testing; Chromatography, High Pressure Liquid; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; 1-Naphthylamine; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Phenethylamines; Ethylamines; Lipids; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services; Chromatography, Liquid; Chromatography; Chemistry Techniques, Analytical; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Matthew P. Goetz, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2008
• First Posted: April 25, 2008
• Study Start: March 16, 2011
• Primary Completion: May 12, 2014
• Study Completion: May 27, 2014
• Last Updated: February 14, 2025

Record last verified: 2024-08

Locations

US (6)