Biomarkers in Blood Samples From Older Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01138345
• Other study ID #: LCCC 0924
• Secondary ID: P30CA016086CDR00
• Status: Completed
• Phase: Phase 1
• First received: June 4, 2010
• Last updated: February 26, 2014
• Start date: January 2010
• Est. completion date: February 2014

Study information

• Verified date: February 2014
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 246
• Est. completion date: February 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Genetic:
• gene expression analysis
blood samples will be analyzed for the expression of the p16 gene.
• reverse transcriptase-polymerase chain reaction
perform reverse transcriptase-polymerase chain reaction on all blood samples.

Other:
• laboratory biomarker analysis
perform laboratory biomarker analysis on all blood samples
• medical chart review
perform medical chart review for all subjects
• questionnaire administration
each cohort will be given the same questionnaire

Locations

Country	Name	City	State
United States	Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	p16INK4a expression between cohort 2 vs cohort 3		2 years	No
Primary	p16INK4a expression between cohort 1 vs cohort 2		2 years	No
Primary	p16INK4a expression between cohorts 1, 2, and 3 vs cohort 4		2 years	No