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


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Ductal Carcinoma in Situ

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Hot flashes

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Leah Cream, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Penn State Hershey Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

PSHCI 08-047

NCT ID:

NCT00886535

Start Date:

February 2010

Completion Date:

December 2013

Related Keywords:

  • Breast Cancer
  • Ductal Carcinoma In Situ
  • breast cancer
  • hot flashes
  • tamoxifen
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating
  • Carcinoma, Ductal, Breast
  • Carcinoma, Ductal

Name

Location

Penn State Hershey Cancer InstituteHershey, Pennsylvania  17033