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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01305954
First received: February 17, 2011
Last updated: February 26, 2014
Last verified: February 2014
  Purpose

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.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: LCCC 1027: Expression Of P16INK4a As A Predictor Of Myelosuppression In Patients With Breast Cancer

Resource links provided by NLM:


Further study details as provided by UNC Lineberger Comprehensive Cancer Center:

Primary Outcome Measures:
  • Determine if p16INK4a Expression at Baseline is Related to Nadir Neutrophil Counts in Women with Breast Cancer Receiving Chemotherapy [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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:
  • Define the Association Between p16INK4a Expression and Physical Activity, Smoking and Alcohol Consumption in Women with Breast Cancer Receiving Chemotherapy [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    To explore the associations between p16INK4a expression at baseline and amount of vigorous physical activity, smoking habits, and weekly alcohol consumption.

  • 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 ] [ Designated as safety issue: No ]
    To explore the associations between p16INK4a expression at baseline and other chemotherapy-related toxicities, including the maximum toxicity experienced during that course of chemotherapy.

  • Explore Associations between p16INK4a Expression at Baseline, Chemotherapy Regimen, and its Effect on Patient Function [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    To explore the associations between p16INK4a expression at baseline and type of chemotherapy received, co-morbidities, concomitant medications, and tumor characteristics.


Biospecimen Retention:   Samples With DNA

Blood samples


Estimated Enrollment: 100
Study Start Date: December 2010
Estimated Study Completion Date: December 2015
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305954

Locations
United States, North Carolina
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
Investigators
Principal Investigator: Hyman Muss, MD University of North Carolina
  More Information

Additional Information:
No publications provided

Responsible Party: UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01305954     History of Changes
Other Study ID Numbers: LCCC1027, 10-2121
Study First Received: February 17, 2011
Last Updated: February 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by UNC Lineberger Comprehensive Cancer Center:
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 21, 2014