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

NCT00899197 | Terminated DMC

• 4 other identifiers: CDR0000547204P30CA012197CCCWFU-74B07CCCWFU-IRB00002657
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer

Outcome Measures

Primary Outcomes (3)

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

• Change in expression levels of protein biomarkers of TAM resistance as measured periodically for 3 years or until relapse, whichever comes first

• Retrospective data on the predictive value of resistance-inducing genes

Interventions

tamoxifen citrate DRUG

gene expression analysis GENETIC

protein expression analysis GENETIC

immunoenzyme technique OTHER

laboratory biomarker analysis OTHER

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Female \>/= 18 years old with confirmed invasive breast cancer

You may qualify if:

• 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

You may not qualify if:

• Severe anemia, defined as hemoglobin \< 11 g/dL
• Psychiatric history that would preclude obtaining informed consent

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tamoxifen; Gene Expression Profiling; Immunoenzyme Techniques

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Genetic Techniques; Investigative Techniques; Immunoassay; Immunologic Techniques; Immunohistochemistry; Molecular Probe Techniques

Study Officials

• Steven A. Akman, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: May 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: June 1, 2012
• Last Updated: August 1, 2017

Record last verified: 2015-09

Locations

US (1)