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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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Locations
United States
Study Type
Observational
Intervention
microarray analysis
polymerase chain reaction
protein expression analysis
diagnostic laboratory biomarker analysis
fluorescent antibody technique
immunohistochemistry staining method
immunologic technique
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Breast Cancer focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General HospitalRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 9, 2009
Last Updated
July 9, 2013
Sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00897065
Brief Title
Biomarkers in Predicting Response to Tamoxifen and Letrozole in Postmenopausal Women With Primary Breast Cancer Treated on Clinical Trial CAN-NCIC-MA17
Official Title
Quantitative Protein and Gene Expression Biomarkers of Tamoxifen and Letrozole Recurrence in the NCIC CTG MA.17 Cohort
Study Type
Observational

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Unknown status
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Enrollment
957 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
microarray analysis
Intervention Type
Genetic
Intervention Name(s)
polymerase chain reaction
Intervention Type
Genetic
Intervention Name(s)
protein expression analysis
Intervention Type
Other
Intervention Name(s)
diagnostic laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
fluorescent antibody technique
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Intervention Type
Other
Intervention Name(s)
immunologic technique
Primary Outcome Measure Information:
Title
Prognostic utility of the MGH 2-gene and the GHI 21-gene expression signatures
Title
Ability of the MGH 2-gene and the GHI 21-gene expression signatures to predict responsiveness to letrozole
Title
Prognostic utility of quantitative immunofluorescence vs standard immunohistochemistry of estrogen receptor, progesterone receptor, HER-2, tumor aromatase, cyclooxygenase-2, GATA-3, and NAT-1
Title
Ability of quantitative immunofluorescence and standard immunohistochemistry of these proteins to predict responsiveness to letrozole
Title
Novel gene expression profiles that may predict outcome and responsiveness to letrozole

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul E. Goss, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Office - Massachusetts General Hospital
Phone
877-726-5130

12. IPD Sharing Statement

Learn more about this trial

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

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