Study of the P16 Gene as a Predictor of Myelosuppression in Breast Cancer Patients

LCCC 1027: Expression Of P16INK4a As A Predictor Of Myelosuppression In Patients With Breast Cancer

The primary purpose of this study is to measure the association between baseline expression of the senescence effector protein p16INK4a and myelosuppression due to chemotherapy in patients with breast cancer. Patients with Stage I-IV breast cancer will be included and myelosuppression will be assessed after the first cycle of chemotherapy via measurement of an absolute neutrophil count (ANC) measured one time between days 7-11 post cycle one. Study subjects will also be asked to complete a brief health behaviors questionnaire to gather information on other relevant variables.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients at UNC North Carolina Cancer Hospital and other participating sights.

Description

Inclusion Criteria:

• ≥ 18 years of age;
• Histologically confirmed Stage I-IV breast cancer;
• ECOG Performance Status 0-3;
• Scheduled to start a new course of chemotherapy in the neo-adjuvant, adjuvant or metastatic setting for newly diagnosed or recurrent disease;
• Growth factors, e.g., filgrastim, pegfilgrastim, are allowed, but their dose and duration will be tracked.
• Absolute Lymphocyte Count (ALC) > 500 cells/μL as determined by routine CBC with differential;
• Signed, IRB approved written informed consent.

Exclusion Criteria:

• Presence of acute, active infection;
• History of clonal bone marrow disorder (i.e., myelodysplastic or myeloproliferative disorder, acute or chronic leukemia);
• Other co-morbid illness which would impair ability to participate in the study;
• Concurrent experimental therapy (Note: concurrent biologic therapy IS permitted, provided it is not experimental).
• Prior or current receipt of histone deacetylase (HDAC) inhibitors

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine if p16INK4a Expression at Baseline is Related to Nadir Neutrophil Counts in Women with Breast Cancer Receiving Chemotherapy	To measure and correlate baseline p16INK4a expression in subjects with stage I-IV breast cancer starting a new course of chemotherapy with a post cycle 1 chemotherapy absolute neutrophil count (ANC).	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Define the Association Between p16INK4a Expression and Physical Activity, Smoking and Alcohol Consumption in Women with Breast Cancer Receiving Chemotherapy	To explore the associations between p16INK4a expression at baseline and amount of vigorous physical activity, smoking habits, and weekly alcohol consumption.	24 months
Explore the Associations between p16INK4a Expression at Baseline and Other Chemotherapy-Related Toxicities including Nausea and Vomiting, Neuropathy, Fatigue and Other Grade 3 and 4 Toxicities	To explore the associations between p16INK4a expression at baseline and other chemotherapy-related toxicities, including the maximum toxicity experienced during that course of chemotherapy.	24 Months
Explore Associations between p16INK4a Expression at Baseline, Chemotherapy Regimen, and its Effect on Patient Function	To explore the associations between p16INK4a expression at baseline and type of chemotherapy received, co-morbidities, concomitant medications, and tumor characteristics.	24 months

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Investigators: Principal Investigator: Hyman Muss, MD, University of North Carolina

Publications and helpful links

Helpful Links

• The Geriatric Oncology Research Program at UNC

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): April 3, 2014
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 17, 2011
• First Submitted That Met QC Criteria: February 25, 2011
• First Posted (Estimated): March 1, 2011

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Treatment; Breast Cancer; Cancer; Gene Therapy; Chemotherapy; Oncology; Blood; Geriatric; Breast; Blood Draw; Gene; UNC; CBC; New Diagnosis; Initial Treatment; North Carolina Cancer Hospital; Lab Draw; Muss
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: LCCC1027; 10-2121 (Other Identifier: UNC Office of Human Research Ethics)