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

NCT01305954 | Completed DMC

• 2 other identifiers: LCCC102710-2121
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast; Cancer; Breast Cancer; New Diagnosis; Treatment; Chemotherapy; Blood; Blood Draw; Lab Draw; Gene; Gene Therapy; Geriatric; Oncology; Muss; UNC; North Carolina Cancer Hospital; Initial Treatment; CBC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Define the Association Between p16INK4a Expression and Physical Activity, Smoking and Alcohol Consumption in Women with Breast Cancer Receiving Chemotherapy

  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

  24 Months

• Explore Associations between p16INK4a Expression at Baseline, Chemotherapy Regimen, and its Effect on Patient Function

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

• The Geriatric Oncology Research Program at UNC

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hyman Muss, MD

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2011
• First Posted: March 1, 2011
• Study Start: December 1, 2010
• Primary Completion: April 3, 2014
• Study Completion: September 25, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

US (1)