Breast Cancer Clinical Trial

Biomarkers in Blood Samples From Older Breast Cancer Survivors

Summary

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors understand how well patients respond to treatment.

PURPOSE: This research study is studying biomarkers in blood samples from older women with stage I, stage II, or stage III breast cancer who have finished primary therapy or breast cancer survivors.

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Full Description

OBJECTIVES:

Primary

To measure and compare normalized p16^INK4a gene expression in women ≥ 65 years of age with stage I-III breast cancer who have completed primary therapy comprising surgery with or without radiotherapy followed by endocrine therapy (cohort 2) versus surgery with or without radiotherapy followed by chemotherapy and with or without endocrine therapy (cohort 3) .
To measure and compare normalized p16^INK4a gene expression in women ≥ 65 years of age with stage I-III breast cancer who have completed primary therapy comprising surgery with or without radiotherapy (cohort 1) versus women treated in cohort 2.
To compare normalized p16^INK4a gene expression between cohorts 1, 2, and 3 versus an age-matched contemporaneous control group of healthy volunteers accrued from a separate study (cohort 4).

Secondary

To access functional status (ability to live independently at home and in the community), co-morbid medical conditions, cognition, psychological status, social functioning and support, medication review, nutritional status, and health-behavior status of these patients.

Tertiary (exploratory)

To compare methodologies of p16 ^INK4a gene expression measurement in 50 patients in order to develop a batchable and analytically validated assay that eliminates the need for rapid sample processing.
To explore any association between p16^INK4a expression and amount of vigorous physical activity, smoking habits, and/or weekly alcohol consumption.
To explore any association between p16^INK4a expression and type of chemotherapy received, co-morbidities, concomitant medications, and/or tumor characteristics.
To correlate p16^INK4a expression with scores from selected domains of the Geriatric Assessment (i.e., cognitive function, activities of daily living (ADL), and the instrumental ADL.

OUTLINE: Breast cancer survivors and healthy volunteers undergo blood collection for p16^INK4a gene expression analysis by Taqman RT-PCR.

Breast cancer survivors complete the Health Behavior and the Geriatric Assessment Questionnaires. They also complete a Timed Up and Go test to determine physical mobility.

Medical charts are reviewed to record information about diagnosis and treatment.

View Eligibility Criteria

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed breast cancer

Stage I-III disease

Breast cancer survivors meeting 1 of the following criteria:

Prior surgery with or without (±) radiotherapy (RT) (cohort 1)

Prior surgery ± RT, followed by prior or concurrent hormonal (endocrine) therapy (cohort 2)

Must have received or be on endocrine therapy for ≥ 3 months
Prior surgery ± RT, followed by prior chemotherapy ± endocrine therapy (cohort 3)
No recurrent disease
No history of clonal bone marrow disorder (i.e., myelodysplastic or myeloproliferative disorder, acute or chronic leukemia)

PATIENT CHARACTERISTICS:

Life expectancy > 12 months
Absolute lymphocyte count > 500/μL
No acute or active infection
No other co-morbid illness that would impair ability to participate in the study

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
At least 3 months since prior surgery with or without radiotherapy
At least 3 months since prior chemotherapy (cohort 3)
No concurrent radiotherapy, chemotherapy, or experimental therapy

Study is for people with:

Breast Cancer

Estimated Enrollment:

246

Study ID:

NCT01138345

Recruitment Status:

Completed

Sponsor:

UNC Lineberger Comprehensive Cancer Center

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There is 1 Location for this study

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Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill North Carolina, 27599, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

246

Study ID:

NCT01138345

Recruitment Status:

Completed

Sponsor:


UNC Lineberger Comprehensive Cancer Center

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