The Clinical and Economic Impact of Pharmacogenomic Testing for Tamoxifen Metabolism in Postmenopausal Women Receiving Tamoxifen for Prevention of Recurrent Breast Cancer

NCT00830973 | Completed DMC

• 1 other identifier: MedcoTamoxifen1
• Study Type: observational
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the impact of CYP450 2D6 genotype pharmacogenetic testing and the corresponding prescribing impact for postmenopausal women using tamoxifen in a patient care setting for prevention of recurrent breast cancer.

Conditions

Breast Neoplasms; Tamoxifen

Keywords

Estrogen Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Hormones; Hormone Substitutes; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Neoplasms; Neoplasms by Site

Outcome Measures

Primary Outcomes (1)

• Determine the prevalence of different CYP450 2D6 phenotypes including poor metabolism status

  14 months

Secondary Outcomes (2)

• Determine the prevalence of concomitant drug therapy involving tamoxifen and potent CYP450 2D6 inhibitors

  14 months

• Determine the effect of CYP450 2D6 genotyping that indicates poor metabolism status has on physician willingness to change tamoxifen therapy within 60 days of receiving test results and accompanying interpretations

  60 days

Study Arms (1)

Active Study Group

The active study group consists of 50 year or older postmenopausal women taking tamoxifen for the prevention of reoccurrence of breast cancer, do not meet exclusion criteria, meet all inclusion criteria, and are enrolled members for Medco clients agreeing to participate.

Other: Poor Metabolism Status Follow Up Therapy Considerations; Other: CYP2D6 Inhibiting Drugs

Interventions

Poor Metabolism Status Follow Up Therapy Considerations OTHER

If the patient's CYP2D6 metabolism status is 'poor' then specialist pharmacist will discuss drug therapy alternatives to tamoxifen.

Also known as: Poor Metabolism

Active Study Group

CYP2D6 Inhibiting Drugs OTHER

If the patient after having a CYP2D6 test has any drugs that inhibit tamoxifen metabolism then specialist pharmacist will contact the physician for alternative drug therapies.

Active Study Group

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The active study group consists of 50 year or older postmenopausal women taking tamoxifen for the prevention of reoccurrence of breast cancer, do not meet exclusion criteria, meet all inclusion criteria, and are enrolled members for Medco clients agreeing to participate.

You may qualify if:

• Patient currently has a pharmacy benefit with Medco for an enrolled client
• Patient has a adjudicated tamoxifen pharmacy claims within the last six months
• Patient is still taking tamoxifen to prevent recurrent breast cancer
• Patient is a natural postmenopausal women 50 years of age or older
• Patient signs consent
• Patient is willing to provide sample for genetic testing
• Physician managing tamoxifen therapy is willing to order pharmacogenetic test

You may not qualify if:

• Patient is male
• Patient is under 50 years old
• Patient has previous history of CYP450 2D6 testing
• Patient is no longer taking tamoxifen
• Patient refuses to sign consent
• Patient wishes to no longer participate after testing
• Patient's physician refuses to order pharmacogenetic test

Sponsors & Collaborators

• Medco Health Solutions, Inc.: lead
• Laboratory Corporation of America: collaborator
• International Business Machines (IBM): collaborator
• Indiana University School of Medicine: collaborator
• Mayo Clinic: collaborator

Study Sites (1)

Robert Epstein

Franklin Lakes, New Jersey, 07417, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Buccal swab

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms; Neoplasms by Site

Condition Hierarchy (Ancestors)

Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Robert Epstein, MD, MS

  Medco Health Solutions, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 26, 2009
• First Posted: January 28, 2009
• Study Start: October 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2009
• Last Updated: October 14, 2009

Record last verified: 2009-10

Locations

US (1)