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

Completed

• Conditions: Breast Cancer
• Interventions: Genetic: polymorphism analysis; Other: laboratory biomarker analysis

• Registration Number: NCT00968214
• Lead Sponsor: Alliance for Clinical Trials in Oncology

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.

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 Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-08-27
• Study First Submitted QC: 2009-08-27
• Study First Posted: 2009-08-28
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-19
• Last Update Posted: 2020-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 364

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single group	laboratory biomarker analysis	DNA from blood specimens that have been previously collected from patients are analyzed for single nucleotide polymorphisms.
Single group	polymorphism analysis	DNA from blood specimens that have been previously collected from patients are analyzed for single nucleotide polymorphisms.

Primary Outcome Measures

Name	Time	Method
Genetic variation associated with musculoskeletal adverse events	Up to 2 years