Clinical trial NCT01305954: Study of the P16 Gene as a Predictor of Myelosuppression in Breast Cancer Patients
Official title: LCCC 1027: Expression Of P16INK4a As A Predictor Of Myelosuppression In Patients With Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2011-03-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer patients at UNC North Carolina Cancer Hospital and other participating sights.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Determine if p16INK4a Expression at Baseline is Related to Nadir Neutrophil Counts in Women with Breast Cancer Receiving Chemotherapy
timeFrame: 24 months
Secondary outcomes:
measure: Define the Association Between p16INK4a Expression and Physical Activity, Smoking and Alcohol Consumption in Women with Breast Cancer Receiving Chemotherapy
timeFrame: 24 months
measure: 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
timeFrame: 24 Months
measure: Explore Associations between p16INK4a Expression at Baseline, Chemotherapy Regimen, and its Effect on Patient Function
timeFrame: 24 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Hyman Muss, MD
role: PRINCIPAL_INVESTIGATOR
References: