Study of Tumor and Blood Samples From Postmenopausal Women With Primary Breast Cancer Enrolled on Clinical Trial CAN-NCIC-MA27

Study Overview
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Brief Summary
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RATIONALE: Studying samples of tumor tissue and blood 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 patients will respond to treatment. PURPOSE: This research study is looking at tumor and blood samples from postmenopausal women with primary breast cancer enrolled on clinical trial CAN-NCIC-MA27.

Detailed Description
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OBJECTIVES: Primary To identify genetic variation, as measured by single nucleotide polymorphisms, that is associated with musculoskeletal adverse events in specimens from postmenopausal women with hormone receptor-positive primary breast cancer receiving adjuvant aromatase inhibitors and enrolled on clinical trial CAN-NCIC-MA27. OUTLINE: This is a multicenter study. DNA from tumor tissue and blood specimens that have been previously collected from patients are analyzed for single nucleotide polymorphisms.

Official Title
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A Genome-Wide Association Study in Patients Experiencing Musculoskeletal Adverse Events on NCIC CTG Trial MA.27 Evaluating Aromatase Inhibitors as Adjuvant Therapy in Early Breast Cancer. A Collaboration Between the NIH Pharmacogenetics Research Network and the RIKEN Yokohama Institute Center for Genomic Medicine.

Conditions
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Breast Cancer

Intervention / Treatment
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* Genetic: polymorphism analysis
* Other: laboratory biomarker analysis


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed invasive breast cancer Complete resection of primary tumor Stage I-III (T1-3, N0-3, M0) disease Enrolled in clinical trial CAN-NCIC-MA27. No locally recurrent or metastatic breast cancer Hormone receptor status: Estrogen receptor- or progesterone receptor-positive disease PATIENT CHARACTERISTICS: Postmenopausal status, defined as one of the following: At least 60 years old Age 45-59 years with spontaneous cessation of menses for > 12 months prior to chemotherapy or study randomization Age 45-59 years with cessation of menses for < 12 months or secondary to hysterectomy AND a follicle-stimulating hormone (FSH) level in the postmenopausal range (or > 34.4 IU/L) Age 45-59 years on hormone replacement therapy (HRT) and discontinued HRT at diagnosis of breast cancer AND FSH level in the postmenopausal range (or > 34.4 IU/L) Bilateral oophorectomy PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single group<br>DNA from blood specimens that have been previously collected from patients are analyzed for single nucleotide polymorphisms. | Genetic: polymorphism analysis<br> <br> Other: laboratory biomarker analysis<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic variation associated with musculoskeletal adverse events |  | Up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, estrogen receptor-positive breast cancer, progesterone receptor-positive breast cancer