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A Pilot Trial Correlating Metabolic Profile of Tamoxifen With Pharmacogenetic Predictors and Clinical Effects

Phase 4
18 Years
70 Years
Not Enrolling
Breast Cancer

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Trial Information

A Pilot Trial Correlating Metabolic Profile of Tamoxifen With Pharmacogenetic Predictors and Clinical Effects

The study will test the following hypotheses.

1. There is a relationship between genetically distinct metabolic profiles of tamoxifen
and the frequency and severity of hot flashes in women on chronic tamoxifen therapy.

2. Genetically distinct metabolic profiles for tamoxifen effect lipid profile, bone
turnover metabolites and bone mineral density, and coagulation factors.

3. Different genetic profiles of estrogen responsive genes influence the pharmacodynamic
effects of tamoxifen in cardiovascular system.

Inclusion Criteria:

1. 18-years or older

2. Women with a prior breast cancer or who are at a high risk for developing the disease
and about to start tamoxifen therapy.

3. Participants must not be treated with concomitant chemotherapy or hormone therapy
other than tamoxifen. They must not have ovarian ablation or currently being treated
with radiation therapy and/or chronic corticosteroids.

4. The participant must not be taking anti-hot flash therapy (clonidine, bellergal,
megestrol acetate). Vitamin E, selective serotonin reuptake inhibitors, or herbal
remedies are allowed provided that the participant has been taking the remedy for at
least 4 weeks and intends to continue the remedy for at least the first month while
on the study, and allows for one-month follow up evaluation (hot flash diaries and
blood samples).

5. The participant must not be pregnant or lactating.

6. The participant is able and willing to sign an informed consent.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

David Flockhart, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University School of Medicine


United States: Federal Government

Study ID:




Start Date:

September 2002

Completion Date:

August 2007

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Tamoxifen
  • Prevention
  • Breast Neoplasms



Indiana University Indianapolis, Indiana  46202
UMCCC Ann Arbor, Michigan  48109