Breast Cancer Clinical Trial

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

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.

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Full 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.

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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

Study is for people with:

Breast Cancer

Estimated Enrollment:

41

Study ID:

NCT00886535

Recruitment Status:

Completed

Sponsor:

Milton S. Hershey Medical Center

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There is 1 Location for this study

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Penn State Hershey Cancer Institute
Hershey Pennsylvania, 17033, United States

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Study is for people with:

Breast Cancer

Estimated Enrollment:

41

Study ID:

NCT00886535

Recruitment Status:

Completed

Sponsor:


Milton S. Hershey Medical Center

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