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Trial Title:
Biomarkers in Predicting Response to Tamoxifen and Letrozole in Postmenopausal Women With Primary Breast Cancer Treated on Clinical Trial CAN-NCIC-MA17
NCT ID:
NCT00897065
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Antibodies
Conditions: 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
Study type:
Observational
Overall status:
Unknown status
Intervention:
Intervention type:
Genetic
Intervention name:
microarray analysis
Intervention type:
Genetic
Intervention name:
polymerase chain reaction
Intervention type:
Genetic
Intervention name:
protein expression analysis
Intervention type:
Other
Intervention name:
diagnostic laboratory biomarker analysis
Intervention type:
Other
Intervention name:
fluorescent antibody technique
Intervention type:
Other
Intervention name:
immunohistochemistry staining method
Intervention type:
Other
Intervention name:
immunologic technique
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.
Criteria for 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
Gender:
Female
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trials Office - Massachusetts General Hospital
Phone:
877-726-5130
Start date:
June 2006
Lead sponsor:
Agency:
Massachusetts General Hospital
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00897065
