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LCCC 1027: Expression Of P16INK4a As A Predictor Of Myelosuppression In Patients With Breast Cancer

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

LCCC 1027: Expression Of P16INK4a As A Predictor Of Myelosuppression In Patients With Breast Cancer

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

- 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

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Determine if p16INK4a Expression at Baseline is Related to Nadir Neutrophil Counts in Women with Breast Cancer Receiving Chemotherapy

Outcome Description:

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).

Outcome Time Frame:

24 months

Safety Issue:


Principal Investigator

Hyman Muss, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of North Carolina


United States: Institutional Review Board

Study ID:




Start Date:

December 2010

Completion Date:

December 2015

Related Keywords:

  • Breast Cancer
  • 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
  • Breast Neoplasms



University of North Carolina Chapel Hill, North Carolina  27599