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


Phase 1
50 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Cross-Sectional

Outcome Measure:

p16INK4a expression between cohort 2 vs cohort 3

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Hyman Muss, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UNC Lineberger Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

LCCC 0924

NCT ID:

NCT01138345

Start Date:

January 2010

Completion Date:

August 2015

Related Keywords:

  • Breast Cancer
  • cancer survivor
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • Breast Neoplasms

Name

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570