Biomarkers in Predicting Response to Tamoxifen and Letrozole in Postmenopausal Women With Primary Breast Cancer Treated on Clinical Trial CAN-NCIC-MA17

NCT00897065 | Unknown

• 2 other identifiers: MGH-MA.17ICSCCDR0000466578
• Study Type: observational
• Target: 957
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients respond to treatment. PURPOSE: This laboratory study is looking at biomarkers that may predict response to tamoxifen and letrozole in postmenopausal women with primary breast cancer treated on clinical trial CAN-NCIC-MA17.

Conditions

Breast Cancer

Keywords

stage IA breast cancer; stage IB breast cancer; stage II breast cancer; stage IIIA breast cancer; estrogen receptor-positive breast cancer; progesterone receptor-positive breast cancer

Outcome Measures

Primary Outcomes (5)

• Prognostic utility of the MGH 2-gene and the GHI 21-gene expression signatures

• Ability of the MGH 2-gene and the GHI 21-gene expression signatures to predict responsiveness to letrozole

• Prognostic utility of quantitative immunofluorescence vs standard immunohistochemistry of estrogen receptor, progesterone receptor, HER-2, tumor aromatase, cyclooxygenase-2, GATA-3, and NAT-1

• Ability of quantitative immunofluorescence and standard immunohistochemistry of these proteins to predict responsiveness to letrozole

• Novel gene expression profiles that may predict outcome and responsiveness to letrozole

Interventions

microarray analysis GENETIC

polymerase chain reaction GENETIC

protein expression analysis GENETIC

diagnostic laboratory biomarker analysis OTHER

fluorescent antibody technique OTHER

immunohistochemistry staining method OTHER

immunologic technique OTHER

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed primary invasive breast carcinoma resected at time of original diagnosis * Treated on clinical trial CAN-NCIC-MA17 * Hormone receptor status: * Estrogen or progesterone receptor positive tumor PATIENT CHARACTERISTICS: * Female * Postmenopausal PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Microarray Analysis; Polymerase Chain Reaction; Fluorescent Antibody Technique; Immunohistochemistry; Immunologic Techniques

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Microchip Analytical Procedures; Investigative Techniques; Nucleic Acid Amplification Techniques; Genetic Techniques; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques

Study Officials

• Paul E. Goss, MD, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: June 1, 2006
• Last Updated: July 10, 2013

Record last verified: 2008-04

Locations

US (1)