Breast CancerNCT01305954
Study of the P16 Gene as a Predictor of Myelosuppression in Breast Cancer Patients
An observational study of Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to 25 Sep 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients at UNC North Carolina Cancer Hospital and other participating sights.
Who may be able to join
- ≥ 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Keywords
- 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
- Medical subject headings
- Breast Neoplasms, Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if p16INK4a Expression at Baseline is Related to Nadir Neutrophil Counts in Women with Breast Cancer Receiving Chemotherapy
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).
Measured: 24 months
Secondary outcomes (3)
Define the Association Between p16INK4a Expression and Physical Activity, Smoking and Alcohol Consumption in Women with Breast Cancer Receiving Chemotherapy
To explore the associations between p16INK4a expression at baseline and amount of vigorous physical activity, smoking habits, and weekly alcohol consumption.
Measured: 24 months
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
To explore the associations between p16INK4a expression at baseline and other chemotherapy-related toxicities, including the maximum toxicity experienced during that course of chemotherapy.
Measured: 24 Months
Explore Associations between p16INK4a Expression at Baseline, Chemotherapy Regimen, and its Effect on Patient Function
To explore the associations between p16INK4a expression at baseline and type of chemotherapy received, co-morbidities, concomitant medications, and tumor characteristics.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startDec 2010
- Primary completion3 Apr 2014
- Study completion25 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hyman Muss, MD, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305954
- Sponsor's protocol ID
- LCCC1027
- Other IDs
- 10-2121
- Status last verified
- Sep 2024
- First submitted
- 17 Feb 2011
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LCCC 1027: Expression Of P16INK4a As A Predictor Of Myelosuppression In Patients With Breast Cancer
- ClinicalTrials.gov ID
- NCT01305954
- Acronym / sponsor ID
- LCCC1027
- Conditions
- Breast Cancer
- Keywords
- Breast, Cancer, Breast Cancer, New Diagnosis, Treatment, Chemotherapy, Blood, Blood Draw
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- 3 Apr 2014 (actual)
- Study completion
- 25 Sep 2023 (actual)
- First posted
- 1 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients at UNC North Carolina Cancer Hospital and other participating sights.
Key inclusion criteria (7 listed)
- ≥ 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine if p16INK4a Expression at Baseline is Related to Nadir Neutrophil Counts in Women with Breast Cancer Receiving Chemotherapy
Time frame: 24 months
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).
3 secondary outcomes
Define the Association Between p16INK4a Expression and Physical Activity, Smoking and Alcohol Consumption in Women with Breast Cancer Receiving Chemotherapy
Time frame: 24 months
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
Explore Associations between p16INK4a Expression at Baseline, Chemotherapy Regimen, and its Effect on Patient Function
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- The Geriatric Oncology Research Program at UNCLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyman Muss, MD principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine if p16INK4a Expression at Baseline is Related to Nadir Neutrophil Counts in Women with Breast Cancer Receiving Chemotherapy (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.