This trial is active, not recruiting.

Condition breast cancer
Sponsor UNC Lineberger Comprehensive Cancer Center
Start date December 2010
End date December 2013
Trial size 100 participants
Trial identifier NCT01305954, 10-2121, LCCC1027


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Determine if p16INK4a Expression at Baseline is Related to Nadir Neutrophil Counts in Women with Breast Cancer Receiving Chemotherapy
time frame: 24 months

Secondary Outcomes

Define the Association Between p16INK4a Expression and Physical Activity, Smoking and Alcohol Consumption in Women with Breast Cancer Receiving Chemotherapy
time frame: 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
time frame: 24 Months
Explore Associations between p16INK4a Expression at Baseline, Chemotherapy Regimen, and its Effect on Patient Function
time frame: 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title LCCC 1027: Expression Of P16INK4a As A Predictor Of Myelosuppression In Patients With Breast Cancer
Principal investigator Hyman Muss, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center.