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.
45 Years
N/A
Female
Breast Cancer
Trial Information
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.
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.
Inclusion Criteria
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
Type of Study:
Observational
Study Design:
N/A
Outcome Measure:
Genetic variation associated with musculoskeletal adverse events
Safety Issue:
No
Principal Investigator
James N. Ingle, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000600225
NCT ID:
NCT00968214
Start Date:
September 2008
Completion Date:
Related Keywords:
- Breast Cancer
- 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
- Breast Neoplasms
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