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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
History of Changes
  Purpose

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.


Condition
Breast Cancer
Ductal Carcinoma in Situ

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Trial of the Effect of Pharmacogenomics Differences in Phase I and II Metabolism of Tamoxifen on Efficacy and Toxicity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Hot flashes [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: February 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00886535

Locations
United States, Pennsylvania
Penn State Hershey Cancer Institute
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Leah Cream, MD Penn State Hershey Cancer Institute
  More Information

No publications provided

Responsible Party: Leah Cream, Assistant Professor of Medicine, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00886535     History of Changes
Other Study ID Numbers: PSHCI 08-047
Study First Received: April 22, 2009
Last Updated: January 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:
breast cancer
hot flashes
tamoxifen

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal, Breast
Carcinoma, Ductal
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
 Neoplasms, Ductal, Lobular, and Medullary
Tamoxifen
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on May 19, 2013