Clinical trial NCT00899197: Tamoxifen Resistance in Women With Stage I, Stage II, Stage IIIA, or Stage IIIB Breast Cancer
Official title: Tamoxifen Resistance in Breast Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Keywords: stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 2
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female \>/= 18 years old with confirmed invasive breast cancer

Brief summary: 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.

Detailed description: OBJECTIVES:

* 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of the mechanisms of tamoxifen citrate (TAM) resistance in breast cancer
measure: Change in expression levels of protein biomarkers of TAM resistance as measured periodically for 3 years or until relapse, whichever comes first
measure: Retrospective data on the predictive value of resistance-inducing genes
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Steven A. Akman, MD
role: STUDY_CHAIR
References: