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Completed

NCT Number: NCT01138345

Biomarkers in Blood Samples From Older Breast Cancer Survivors

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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Key information

Age range

50 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gene expression analysis

Genetic

blood samples will be analyzed for the expression of the p16 gene.

reverse transcriptase-polymerase chain reaction

Genetic

perform reverse transcriptase-polymerase chain reaction on all blood samples.

laboratory biomarker analysis

Other

perform laboratory biomarker analysis on all blood samples

medical chart review

Other

perform medical chart review for all subjects

Questionnaire Administration

Other

each cohort will be given the same questionnaire

Primary outcomes

  1. p16INK4a expression between cohort 2 vs cohort 3

    Time frame: 2 years

  2. p16INK4a expression between cohort 1 vs cohort 2

    Time frame: 2 years

  3. p16INK4a expression between cohorts 1, 2, and 3 vs cohort 4

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Jun 7, 2010
Registry last updated
Feb 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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