Biomarkers in Blood Samples From Older Breast Cancer Survivors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Chemotherapy on Aging in Older Women With Breast Cancer as Measured by Expression of p16INK4a

Conditions
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Breast Cancer

Intervention / Treatment
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* Genetic: gene expression analysis
* Genetic: reverse transcriptase-polymerase chain reaction
* Other: laboratory biomarker analysis
* Other: medical chart review
* Other: questionnaire administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment w/Surgery<br>Breast Cancer survivors treated with surgery with or without radiation. | Genetic: gene expression analysis<br>* blood samples will be analyzed for the expression of the p16 gene.<br>Genetic: reverse transcriptase-polymerase chain reaction<br>* perform reverse transcriptase-polymerase chain reaction on all blood samples.<br>Other: laboratory biomarker analysis<br>* perform laboratory biomarker analysis on all blood samples<br>Other: medical chart review<br>* perform medical chart review for all subjects<br>Other: questionnaire administration<br>* each cohort will be given the same questionnaire<br>|
| Treatment w/endocrine therapy<br>Breast Cancer survivors treated with surgery with or without radiation plus endocrine therapy. | Genetic: gene expression analysis<br>* blood samples will be analyzed for the expression of the p16 gene.<br>Genetic: reverse transcriptase-polymerase chain reaction<br>* perform reverse transcriptase-polymerase chain reaction on all blood samples.<br>Other: laboratory biomarker analysis<br>* perform laboratory biomarker analysis on all blood samples<br>Other: medical chart review<br>* perform medical chart review for all subjects<br>Other: questionnaire administration<br>* each cohort will be given the same questionnaire<br>|
| Treatment w/ chemotherapy<br>Breast Cancer survivors treated with surgery with or without radiation and chemotherapy with or without endocrine therapy. | Genetic: gene expression analysis<br>* blood samples will be analyzed for the expression of the p16 gene.<br>Genetic: reverse transcriptase-polymerase chain reaction<br>* perform reverse transcriptase-polymerase chain reaction on all blood samples.<br>Other: laboratory biomarker analysis<br>* perform laboratory biomarker analysis on all blood samples<br>Other: medical chart review<br>* perform medical chart review for all subjects<br>Other: questionnaire administration<br>* each cohort will be given the same questionnaire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| p16INK4a expression between cohort 2 vs cohort 3 |  | 2 years | 
| p16INK4a expression between cohort 1 vs cohort 2 |  | 2 years | 
| p16INK4a expression between cohorts 1, 2, and 3 vs cohort 4 |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer survivor, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer