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

NCT00968214 | Completed

• 3 other identifiers: NCCTG-TBCI-MA.27ACDR0000600225NCI-2009-00694
• Study Type: observational
• Target: 364
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• Genetic variation associated with musculoskeletal adverse events

  Up to 2 years

Study Arms (1)

Single group

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

Genetic: polymorphism analysis; Other: laboratory biomarker analysis

Interventions

polymorphism analysis GENETIC

Single group

laboratory biomarker analysis OTHER

Single group

Eligibility Criteria

• Age: 45 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Alliance for Clinical Trials in Oncology: lead
• National Cancer Institute (NCI): collaborator

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Amplified Fragment Length Polymorphism Analysis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DNA Fingerprinting; Genetic Techniques; Investigative Techniques; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques

Study Officials

• James Ingle, MD

  Mayo Clinic

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2009
• First Posted: August 28, 2009
• Study Start: September 1, 2008
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: February 21, 2020

Record last verified: 2020-02