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

NCT ID: NCT00968214

Last Updated: 2020-02-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 364 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2018-09-30

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Single group

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

polymorphism analysis

Intervention Type: GENETIC

laboratory biomarker analysis

Intervention Type: OTHER

Interventions

polymorphism analysis

Intervention Type: GENETIC

laboratory biomarker analysis

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James Ingle, MD

Role: STUDY_CHAIR

Mayo Clinic

Other Identifiers

NCCTG-TBCI-MA.27A

Identifier Type: -

Identifier Source: secondary_id

CDR0000600225

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2009-00694

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCCTG-TBCI-MA.27A

Identifier Type: -

Identifier Source: org_study_id