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

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ClinicalTrials.gov Identifier: NCT00968214
Recruitment Status : Active, not recruiting
First Posted : August 28, 2009
Last Update Posted : August 8, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Tracking Information
First Submitted Date August 27, 2009
First Posted Date August 28, 2009
Last Update Posted Date August 8, 2017
Study Start Date September 2008
Estimated Primary Completion Date January 2100   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 11, 2016)
Genetic variation associated with musculoskeletal adverse events [ Time Frame: Up to 2 years ]
Original Primary Outcome Measures
 (submitted: August 27, 2009)
Genetic variation associated with musculoskeletal adverse events
Change History Complete list of historical versions of study NCT00968214 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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.
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
blood
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
Condition Breast Cancer
Intervention
  • Genetic: polymorphism analysis
  • Other: laboratory biomarker analysis
Study Groups/Cohorts Single group
DNA from blood specimens that have been previously collected from patients are analyzed for single nucleotide polymorphisms.
Interventions:
  • Genetic: polymorphism analysis
  • Other: laboratory biomarker analysis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: August 27, 2009)
364
Original Estimated Enrollment Same as current
Study Completion Date Not Provided
Estimated Primary Completion Date January 2100   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: Female
Ages 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00968214
Other Study ID Numbers NCCTG-TBCI-MA.27A
NCCTG-TBCI-MA.27A
CDR0000600225 ( Registry Identifier: PDQ (Physician Data Query) )
NCI-2009-00694 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Alliance for Clinical Trials in Oncology
Study Sponsor Alliance for Clinical Trials in Oncology
Collaborators National Cancer Institute (NCI)
Investigators
Study Chair: James Ingle, MD Mayo Clinic
PRS Account Alliance for Clinical Trials in Oncology
Verification Date August 2017