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

Alliance for Clinical Trials in Oncology

Status: Completed

Conditions: Breast Cancer

Treatments: Other: laboratory biomarker analysis; Genetic: polymorphism analysis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00968214

CDR0000600225 (Registry Identifier)

NCI-2009-00694 (Registry Identifier)

NCCTG-TBCI-MA.27A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 364 estimated patients

Sex: Female

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

364 participants in 1 patient group

Single group

Description:

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

Treatment:

Genetic: polymorphism analysis

Other: laboratory biomarker analysis