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

Sponsor:	Massachusetts General Hospital
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00897065

Purpose

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.

Condition	Intervention
Breast Cancer	Genetic: microarray analysis Genetic: polymerase chain reaction Genetic: protein expression analysis Other: fluorescent antibody technique Other: immunohistochemistry staining method Other: immunologic technique Other: laboratory biomarker analysis

Study Type:	Observational
Official Title:	Quantitative Protein and Gene Expression Biomarkers of Tamoxifen and Letrozole Recurrence in the NCIC CTG MA.17 Cohort

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer Help Me Understand Genetics

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Tamoxifen Letrozole

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Prognostic utility of the MGH 2-gene and the GHI 21-gene expression signatures [ Designated as safety issue: No ]
Ability of the MGH 2-gene and the GHI 21-gene expression signatures to predict responsiveness to letrozole [ Designated as safety issue: No ]
Prognostic utility of quantitative immunofluorescence vs standard immunohistochemistry of estrogen receptor, progesterone receptor, HER-2, tumor aromatase, cyclooxygenase-2, GATA-3, and NAT-1 [ Designated as safety issue: No ]
Ability of quantitative immunofluorescence and standard immunohistochemistry of these proteins to predict responsiveness to letrozole [ Designated as safety issue: No ]
Novel gene expression profiles that may predict outcome and responsiveness to letrozole [ Designated as safety issue: No ]

Estimated Enrollment:	957
Study Start Date:	June 2006

Detailed Description:

OBJECTIVES:

Assess the prognostic utility of the MGH 2-gene and the GHI 21-gene expression signatures in postmenopausal women with primary breast cancer treated with tamoxifen followed by either placebo or letrozole on clinical trial CAN-NCIC-MA17.
Assess the ability of the MGH 2-gene and the GHI 21-gene expression signatures to predict responsiveness to letrozole.
Compare the prognostic utility of quantitative immunofluorescence vs standard immunohistochemistry of estrogen receptor, progesterone receptor, HER-2, tumor aromatase, cyclooxygenase-2, GATA-3, and NAT-1 in these patients.
Assess the ability of quantitative immunofluorescence and standard immunohistochemistry of these proteins to predict responsiveness to letrozole in these patients.
Use gene discovery from formalin-fixed, paraffin-embedded tumor specimens to identify novel gene expression profiles that may predict outcome and responsiveness to letrozole in these patients.

OUTLINE: This is a controlled study.

Formalin-fixed, paraffin-embedded breast tumor tissue samples are analyzed for MGH 2-gene and GHI 21-gene expression signatures using real-time quantitative polymerase chain reaction. Immunohistochemistry and immunofluorescence are used for analysis of estrogen receptor, progesterone receptor, HER-1 and -2, aromatase, GATA-3, NAT-1, and cyclooxygenase-2. Microarray hybridization is used to identify novel gene expression signatures.

PROJECTED ACCRUAL: A total of 957 specimens will be accrued for this study.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897065

Locations

United States, Massachusetts
Massachusetts General Hospital	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Clinical Trials Office - Massachusetts General Hospital 877-726-5130

Sponsors and Collaborators

Massachusetts General Hospital

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Paul E. Goss, MD, PhD

Massachusetts General Hospital

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000466578, MGH-MA.17ICSC
Study First Received:	May 9, 2009
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00897065 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on February 08, 2010