Biomarkers in Predicting Response to Tamoxifen and Letrozole in Postmenopausal Women With Primary Breast Cancer Treated on Clinical Trial CAN-NCIC-MA17
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/2/2016 |
| Start Date: | June 2006 |
Quantitative Protein and Gene Expression Biomarkers of Tamoxifen and Letrozole Recurrence in the NCIC CTG MA.17 Cohort
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.
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.
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.
- 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.
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
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