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

Breast Cancer Clinical Trial

Official title:

Tamoxifen Resistance in Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00899197
• Other study ID #: CDR0000547204
• Secondary ID: P30CA012197CCCWF
• Status: Terminated
• Phase: N/A
• First received: May 9, 2009
• Last updated: July 31, 2017
• Start date: May 2007
• Est. completion date: June 2012

Study information

• Verified date: September 2015
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 2012
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• tamoxifen citrate

Genetic:
• gene expression analysis

• protein expression analysis

Other:
• immunoenzyme technique

• laboratory biomarker analysis

Locations

Country	Name	City	State
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the mechanisms of tamoxifen citrate (TAM) resistance in breast cancer
Primary	Change in expression levels of protein biomarkers of TAM resistance as measured periodically for 3 years or until relapse, whichever comes first
Primary	Retrospective data on the predictive value of resistance-inducing genes