Effect of Pharmacogenomics Differences in Phase I and II Metabolism of Tamoxifen on Efficacy and Toxicity

NCT ID: NCT00886535

Last Updated: 2019-03-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 41 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2017-07-27

Brief Summary

This study will be an open-label prospective observational trial designed to test associations between polymorphisms of candidate genes and tamoxifen. Pre- and post-menopausal women taking tamoxifen as standard therapy or chemopreventive therapy will be included in this study.

Detailed Description

This study will be an open-label prospective observational trial designed to test associations between polymorphisms of candidate genes (focusing initially on the UGT2B7 enzyme) and tamoxifen (TAM) toxicity. Pre- & post-menopausal women (aged ≥18 years) taking TAM (20 mg/day) as standard therapy or chemopreventive therapy will be included in this study. Patients will be enrolled after they complete all primary surgery, radiation, and adjuvant chemotherapy. Patients will be excluded if they are undergoing other adjuvant endocrine therapies. Other reasons for exclusion will include patients who are pregnant or lactating, or are currently on corticosteroids, phenobarbital, or megestrol acetate. The goal will be to recruit a total of 45 eligible patients over a 1 year accrual period. The investigators expect to treat ~50 new patients per year with TAM at the standard dose of 20 mg/day.

Conditions

Breast Cancer; Ductal Carcinoma in Situ

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patients receiving tamoxifen for adjuvant therapy of breast cancer or ductal carcinoma in situ, or as chemoprevention
• Age 18 years and above
• May be pre- and post-menopausal
• Females
• Patients may be at any point in their hormonal treatment, but must have completed any planned surgery, radiation and chemotherapy
• Must use a reliable form of birth control

Exclusion Criteria

• Pregnant
• Breastfeeding
• Concurrent use of corticosteroids, megestrol, or phenobarbital
• History of allergy to tamoxifen
• Unwilling to have a yearly gynecological exam

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Leah Cream

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Leah Cream, MD

Role: PRINCIPAL_INVESTIGATOR

Penn State Hershey Cancer Institute

Locations

Penn State Hershey Cancer Institute

Hershey, Pennsylvania, United States

Countries

United States

Other Identifiers

PSHCI 08-047

Identifier Type: -

Identifier Source: org_study_id