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
Recruitment status was Recruiting
Sponsor:
Massachusetts General Hospital
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00897065
First received: May 9, 2009
Last updated: May 21, 2013
Last verified: April 2008
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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:
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 |
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
Investigators
| Principal Investigator: | Paul E. Goss, MD, PhD | Massachusetts General Hospital |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00897065 History of Changes |
| Other Study ID Numbers: | MGH-MA.17ICSC, CDR0000466578 |
| Study First Received: | May 9, 2009 |
| Last Updated: | May 21, 2013 |
| 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 May 23, 2013