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

Active, not recruiting

• Conditions: Breast Cancer

• Registration Number: NCT01305954
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-02-17
• Study First Submitted QC: 2011-02-25
• Study First Posted: 2011-03-01
• Primary Completion: 2014-04-03
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-11-28
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determine if p16INK4a Expression at Baseline is Related to Nadir Neutrophil Counts in Women with Breast Cancer Receiving Chemotherapy	24 months	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States