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

Plain-language summary

This study examines whether the P16 gene can be used to predict chemotherapy-related bone marrow suppression (myelosuppression) in patients with breast cancer. It included patients aged 18 and older with confirmed Stage I-IV breast cancer who were about to start a new course of chemotherapy. It was carried out as a study with no assigned phase and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

UNC Lineberger Comprehensive Cancer Center

Start date

12/1/2010

Estimated completion

9/25/2023

Countries

United States

Related genes

Locations

• Chapel Hill, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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