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Biomarkers in Predicting Response to Tamoxifen and Letrozole in Postmenopausal Women With Primary Breast Cancer Treated on Clinical Trial CAN-NCIC-MA17
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by National Cancer Institute (NCI).   Recruitment status was  Recruiting

First Received on May 9, 2009.   Last Updated on June 14, 2011   History of Changes
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: diagnostic laboratory biomarker analysis
Other: fluorescent antibody technique
Other: immunohistochemistry staining method
Other: immunologic technique

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 Tamoxifen citrate Letrozole Immunoglobulins Globulin, Immune
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

ClinicalTrials.gov Identifier: NCT00897065     History of Changes
Other Study ID Numbers: CDR0000466578, MGH-MA.17ICSC
Study First Received: May 9, 2009
Last Updated: June 14, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Antibodies
Tamoxifen
Letrozole
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
 Antineoplastic Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Bone Density Conservation Agents
Estrogen Antagonists
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012



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