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

Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00968214
• Other study ID #: NCCTG-TBCI-MA.27A
• Secondary ID: NCCTG-TBCI-MA.27
• Status: Completed
• Start date: September 2008
• Est. completion date: September 2018

Study information

• Verified date: February 2020
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 364
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Genetic:
• polymorphism analysis

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genetic variation associated with musculoskeletal adverse events		Up to 2 years