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Completed

NCT Number: NCT00968214

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

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.

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Key information

Age range

45 year and older

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

polymorphism analysis

Genetic

laboratory biomarker analysis

Other

Primary outcomes

  1. Genetic variation associated with musculoskeletal adverse events

    Time frame: Up to 2 years

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2018
Study completion
2018
First posted
Aug 28, 2009
Registry last updated
Feb 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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