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

This study has suspended participant recruitment.
(interim analysis)
Sponsor:
Information provided by (Responsible Party):
Leah Cream, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT00886535
First received: April 22, 2009
Last updated: January 8, 2013
Last verified: January 2013

April 22, 2009
January 8, 2013
February 2010
December 2013   (final data collection date for primary outcome measure)
Hot flashes [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00886535 on ClinicalTrials.gov Archive Site
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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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Females, age 18 years of age and above. Patients receiving tamoxifen for adjuvant therapy of breast cancer or ductal carcinoma in situ or as chemoprevention.

  • Breast Cancer
  • Ductal Carcinoma in Situ
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
50
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00886535
PSHCI 08-047
No
Leah Cream, Milton S. Hershey Medical Center
Milton S. Hershey Medical Center
Not Provided
Principal Investigator: Leah Cream, MD Penn State Hershey Cancer Institute
Milton S. Hershey Medical Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP