Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments polymorphism analysis, laboratory biomarker analysis
Sponsor Alliance for Clinical Trials in Oncology
Collaborator National Cancer Institute (NCI)
Start date September 2008
End date January 2100
Trial size 364 participants
Trial identifier NCT00968214, CDR0000600225, NCCTG-TBCI-MA.27A, NCI-2009-00694

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
DNA from blood specimens that have been previously collected from patients are analyzed for single nucleotide polymorphisms.
polymorphism analysis
laboratory biomarker analysis

Primary Outcomes

Measure
Genetic variation associated with musculoskeletal adverse events
time frame: Up to 2 years

Eligibility Criteria

Female participants at least 45 years old.

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

Additional Information

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.
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Alliance for Clinical Trials in Oncology.