Clinical trial NCT00968214: Study of Tumor and Blood Samples From Postmenopausal Women With Primary Breast Cancer Enrolled on Clinical Trial CAN-NCIC-MA27
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-08-28
Enrollment: 364
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants in the MA.27 clinical trial who received either anastrozole or exemestane for adjuvant therapy of resected early 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.

Eligibility 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

Primary outcomes:
measure: Genetic variation associated with musculoskeletal adverse events
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: James Ingle, MD
role: STUDY_CHAIR
References: