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

Sponsor

Alliance for Clinical Trials in Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT00968214

Collaborator

National Cancer Institute (NCI) (NIH)

364

Enrollment

120

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Genetic: polymorphism analysis Other: laboratory biomarker analysis

Detailed Description

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

364 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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.

Actual Study Start Date :

Sep 1, 2008

Actual Primary Completion Date :

Sep 1, 2018

Actual Study Completion Date :

Sep 1, 2018

Arms and Interventions

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

Arm

Intervention/Treatment

Single group

DNA from blood specimens that have been previously collected from patients are analyzed for single nucleotide polymorphisms.

Genetic: polymorphism analysis

Other: laboratory biomarker analysis

Outcome Measures

Primary Outcome Measures

Genetic variation associated with musculoskeletal adverse events [Up to 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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