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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00968214

Enrollment

364

Registered

2009-08-28

Start date

2008-09-30

Completion date

2018-09-30

Last updated

2020-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

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

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.

Interventions

GENETICpolymorphism analysis

OTHERlaboratory biomarker analysis

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

45 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026