Tamoxifen Resistance in Women With Stage I, Stage II, Stage IIIA, or Stage IIIB Breast Cancer

This study has been terminated.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
First received: May 9, 2009
Last updated: September 29, 2015
Last verified: September 2015

RATIONALE: Studying samples of blood from patients with breast cancer in the laboratory may help doctors identify and learn more about biomarkers related to tamoxifen resistance.

PURPOSE: This laboratory study is looking at tamoxifen resistance in women with stage I, stage II, stage IIIA, or stage IIIB breast cancer.

Condition Intervention
Breast Cancer
Drug: tamoxifen citrate
Genetic: gene expression analysis
Genetic: protein expression analysis
Other: immunoenzyme technique
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tamoxifen Resistance in Breast Cancer

Resource links provided by NLM:

Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • Evaluation of the mechanisms of tamoxifen citrate (TAM) resistance in breast cancer [ Designated as safety issue: No ]
  • Change in expression levels of protein biomarkers of TAM resistance as measured periodically for 3 years or until relapse, whichever comes first [ Designated as safety issue: No ]
  • Retrospective data on the predictive value of resistance-inducing genes [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: May 2007
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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 TAM]).

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.


Ages Eligible for Study:   18 Years to 120 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Female >/= 18 years old with confirmed invasive breast cancer

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00899197

United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Study Chair: Steven A. Akman, MD Comprehensive Cancer Center of Wake Forest University
  More Information

No publications provided

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT00899197     History of Changes
Other Study ID Numbers: CDR0000547204  P30CA012197  CCCWFU-74B07  CCCWFU-IRB00002657 
Study First Received: May 9, 2009
Last Updated: September 29, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Bone Density Conservation Agents
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Selective Estrogen Receptor Modulators
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2016