CompletedNot Applicable

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

United States100 participantsStarted 2010-12

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 24 months

Trial details

NCT IDNCT01305954

SponsorUNC Lineberger Comprehensive Cancer Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2014-04-03

View on ClinicalTrials.gov More Breast Cancer trials