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

An Observational Trial of the Effect of Pharmacogenomics Differences in Phase I and II Metabolism of Tamoxifen on Efficacy and Toxicity

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00886535

Enrollment

Registered

2009-04-23

Start date

2010-02-28

Completion date

2017-07-27

Last updated

2019-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Ductal Carcinoma in Situ

Keywords

breast cancer, hot flashes, tamoxifen

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Hot flashes	2 years

Countries

United States

Outcome results