Study of the P16 Gene as a Predictor of Myelosuppression in Breast Cancer Patients
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/8/2018 |
| Start Date: | December 2010 |
| End Date: | December 2018 |
LCCC 1027: Expression Of P16INK4a As A Predictor Of Myelosuppression In Patients With Breast Cancer
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.
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.
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
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