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Tamoxifen Resistance in Breast Cancer

18 Years
Not Enrolling
Breast Cancer

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Trial Information

Tamoxifen Resistance in Breast Cancer


- Identify women who are resistant to tamoxifen citrate and other drugs for the treatment
of breast cancer by testing their plasma for the presence of proteins (e.g., macrophage
migration inhibition factor) encoded by resistance-inducing genes (RIGs).

- Provide retrospective data on the predictive value of RIGs to serve as the basis for a
prospective clinical trial of these genes as predictors of drug resistance.

OUTLINE: This is a multicenter study. Patients are stratified according to response during
tamoxifen citrate (TAM) therapy (resistant group [i.e., those who develop recurrent breast
cancer while being treated with TAM] vs conditionally sensitive group [i.e., those who have
disease-free survival for over 3 years after initial diagnosis while being treated with

Patients undergo blood collection at baseline, within 3 weeks of initiation of TAM therapy,
and then every 6 months for 3 years or until relapse, whichever comes first. Samples are
analyzed by enzyme-linked immunosorbent assay for expression of protein biomarkers (i.e.,
kallikrein gene 10, macrophage migration inhibition factor, prolyl carboxypeptidase, queuine
tRNA-ribosyltransferase, and kinesin) encoded by resistance-inducing genes. An additional
blood sample is obtained from patients at the time of relapse, if available.

Patients also undergo assessment of medical history, personal habits, and characteristics of
breast cancer (e.g., tumor histology, stage, and grade) at baseline.

Inclusion Criteria:

- Histologically confirmed invasive breast cancer

- Initial pathologic stage I-IIIB disease

- No stage IV disease

- Meets the following criteria for breast cancer therapy:

- Received prior primary local therapy for breast cancer

- Scheduled to begin tamoxifen citrate as adjuvant therapy for breast cancer
within 3 weeks

- Hormone receptor status:

- Estrogen-receptor positive tumor

- Female

- Pre- or post-menopausal

- Must be able to donate 20 mL of blood

Exclusion Criteria:

- Severe anemia, defined as hemoglobin < 11 g/dL

- Psychiatric history that would preclude obtaining informed consent

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Evaluation of the mechanisms of tamoxifen citrate (TAM) resistance in breast cancer

Safety Issue:


Principal Investigator

Steven A. Akman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University


United States: Institutional Review Board

Study ID:




Start Date:

May 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • Breast Neoplasms



Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096