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Studying Blood Samples From Women With Breast Cancer or Ductal Carcinoma In Situ Who Are Receiving Tamoxifen

NCT00764322 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 501

Last updated 2017-08-01

Study results available
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Summary

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about differences in DNA and predict how well patients will respond to treatment and plan better treatment.

PURPOSE: This clinical trial is studying blood samples from women with breast cancer or ductal carcinoma in situ who are receiving tamoxifen.

Conditions

Interventions

DRUG

tamoxifen citrate

Women found to be IM or PM will undergo increased tamoxifen to 40 mg/day (20 mg bid). Drug is given orally on a daily basis.

GENETIC

gene expression analysis

Genetic analysis of blood sample.

OTHER

pharmacogenomic studies

Genetic analysis of blood sample.

OTHER

questionnaire administration

Questionnaire called the survey of participants. Questionnaires is self administered on paper documents and given pre-study, and at 4 months

PROCEDURE

quality-of-life assessment

Self administration of a multiquestion questionnaire called the Functional Assessment of Cancer Therapy -Breast (FACT-B). Given pre-study, at 4 months and at 8-10 months.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Lisa A. Carey, MD · UNC Lineberger Comprehensive Cancer Center

  • William J. Irvin, MD · Bon Secours Virginia Health System / Bon Secours Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
120 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-18
Primary Completion
2010-09-28
Completion
2011-07-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00764322 on ClinicalTrials.gov