Breast CancerEarly Phase 1NCT03361800
Window of Opportunity Trial of Entinostat in Patients With Newly Diagnosed Stage I-IIIC,TNBC
A Early Phase 1 study testing Entinostat in people with Breast Cancer and Invasive Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
This study is investigational and is not designed to treat cancer. In other words, the study drug, entinostat, is not being given to treat cancer. Instead, the study team is looking at the effects of entinostat on tumor tissue for research purposes only. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Invasive Breast Cancer, ER-Negative PR-Negative HER2-Negative Breast Cancer
- What is being tested?
- Entinostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2018to 11 Oct 2019
- Phase
- Early Phase 1
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Is female, age ≥ 18 years of age.
- For Part 1: Has histologically confirmed newly diagnosed Stage I-IIIC invasive breast cancer that is triple negative (ER/PR <1%, Her2 negative) and is scheduled to undergo definitive surgery (either lumpectomy, mastectomy) and meets the criteria listed below:
- Scheduled for lumpectomy or mastectomy and not considered a candidate for neoadjuvant systemic treatment
- No prior or current therapy for breast cancer
- Amenable to a baseline research breast biopsy
- For Part 2: Has histologically confirmed newly diagnosed Stage I-IIIC invasive breast cancer that is ER positive (+/- PR positive) and is scheduled to undergo definitive surgery (either lumpectomy, mastectomy) and meets the criteria listed below:
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- Scheduled for lumpectomy or mastectomy and not considered a candidate for neoadjuvant systemic treatment b. No prior or current therapy for breast cancer c. Amenable to a baseline research breast biopsy
- Must have sufficient time to receive two doses of entinostat 7 days apart or exemestane for 8 consecutive days with or without entinostat prior to surgery.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
- Demonstrates adequate organ function
- Has normal cardiac function based on an electrocardiogram (ECG) with no clinically significant abnormalities or risks including any of the following:
- Current uncontrolled hypertension (systolic >150 mm Hg and/or diastolic >100 mmHg) or unstable angina
- History of serious cardiac arrhythmia requiring treatment (exceptions: atrial fibrillation, paroxysmal supraventricular tachycardia)
- History of myocardial infarction within 6 months of day 1 of dosing
- History of congestive heart failure according to New York Heart Association (NYHA) criteria.
- For women of childbearing potential: Has a negative serum pregnancy test at screening within 72 hrs of receiving study treatment. In addition, female subjects must either:
- agree to the use of an approved method of contraception (ie, two adequate barrier methods throughout the study starting with the screening visit) and to continue its use for the duration of the study treatment through 120 days after the last dose of entinostat if a woman of child-bearing potential, or
- has documented inability to become pregnant (e.g., hysterectomy, bilateral tubal ligation or oophorectomy, or post-menopausal as defined as total cessation of menses for ≥ 2 years). Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure otherwise the patient must be willing to use 2 adequate barrier methods throughout the study.
- Is able to swallow and retain oral medication.
- As determined by the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.
Who cannot join
- Stage IV breast cancer.
- Has clinically significant a) abnormal laboratory or ECG findings, b) history of myocardial infarction or arterial thromboembolic events within 6 months of screening or c) unstable angina, d) New York Heart Association (NYHA) Class III or IV disease or e) a corrected QT (QTc) interval > 470 msec.
- Medical history of uncontrolled hypertension (NCI CTCAE grade 3 or 4) or diabetes mellitus.
- Known active central nervous system metastases and/or carcinomatous meningitis.
- Prior history of another cancer within the previous 5 years with the exception of adequately treated basal cell carcinoma or cervical intraepithelial neoplasia, cervical carcinoma in situ or melanoma in situ.
- Another known malignancy other than breast cancer that is progressing or requires active treatment.
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- Is pregnant or lactating, or is of child-bearing potential and not willing to use an approved method of contraception.
- Has a concomitant medical condition that precludes adequate study treatment compliance or assessment, such as bleeding disorders or any other medical condition that would increase risks of additional core biopsy for biomarkers.
- Is currently receiving treatment with a medication on the prohibited medication list for entinostat (See section 11.1 Appendix A and section 4.5).
- Has allergy to benzamides or inactive components of the study medication (entinostat).
- Inability to take oral medications (eg, impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral medications such as ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
- Is participating in another therapeutic clinical trial or has received another investigational agent within 30 days prior to informed consent.
- Known human immunodeficiency virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (with the exception of chronic or cleared HBV and HCV infection which is allowed).
- Has acute or currently active/requiring anti-viral therapy, hepatic or biliary disease (with the exception of patients with Gilbert's syndrome, asymptomatic gallstones, or stable chronic liver disease per investigator assessment).
- Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
- Medical history of an autoimmune disease that requires ongoing steroid therapy for > 14 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Lineberger Comprehensive Cancer Center at University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: A Non-randomized, Non-comparative, Open-label, Window Trial of Entinostat Given With or Without Exemestane in Patients With Newly Diagnosed, Stage I-IIIC, Hormone Receptor - Positive (HR+) or Triple Negative Breast Cancer (TNBC)
This study is investigational and is not designed to treat cancer. In other words, the study drug, entinostat, is not being given to treat cancer. Instead, the study team is looking at the effects of entinostat on tumor tissue for research purposes only.
Approximately 246,660 cases of breast cancer were diagnosed in the United States in 2016. Its detection and treatment remains a major concern in women's healthcare. In particular, TNBC accounts for approximately 15-20% of all breast cancers. Research into treatment for breast cancer relies more and more on understanding how the cancer cells act when they are exposed to an anti-cancer drug. How most cancer cells act when exposed to anti-cancer drugs and which patients as a result may benefit the most from these drugs is not well known. Additional studies are required to determine the cells' reactions. The purpose of part 1 of this study is to better understand how TNBC tumors react to one particular cancer drug, entinostat. Entinostat is currently being studied across multiple clinical trials for the treatment of breast cancer, other solid tumors and blood cancers. Entinostat is investigational and has not yet been FDA approved for the treatment of cancer.
Studies have shown that a good way to determine how cancer acts when exposed to anti-cancer drugs is a short-term preoperative window study. In this type of study, subjects receive a study drug a couple of days before surgery. Leftover tissue from surgery is then used to determine some of the effects that a study drug may have on the tumor. In this study, subjects will receive two doses of entinostat prior to undergoing planned surgery. Leftover tissue from this surgery will then be used to determine the effects entinostat has on tumor cells. For example, the study team will examine if the types of genes and proteins that the tumor expresses as a result of entinostat exposure increases or decreases the likelihood that the tumor will not continue to grow. A gene is a unit of DNA. Genes make up the chemical structure carrying your genetic information that may determine human characteristics (i.e., eye color, height and sex). This study will focus on discovering how entinostat affects a wide variety of genes in tumor cells.
Read the detailed description
Primary Objective and Endpoint To identify decrease in Ki-67 mRNA following treatment with entinostat across TNBC breast cancers.
Secondary Objectives and Endpoints To identify messenger ribonucleic acid (mRNA) gene expression changes following treatment with entinostat, across TNBC.
To evaluate changes in the proliferation signature by mRNA expression following treatment with entinostat across TNBC.
To identify differential kinome activation before and after treatment with entinostat across TNBC
To correlate mutation and/or copy number variations by whole exome sequencing (WES) with mRNA gene expression changes and reduction of proliferation signature following treatment with entinostat across TNBC.
To correlate protein lysine hyperacetylation in peripheral blood and tumor from pre- and post-entinostat treated TNBCs.
To explore molecular subtype, Programmed death-ligand 1 (PD-L1) and other immune checkpoint molecule expression, immune gene and innate anti-programed cell death-1 resistance (IPRES) expression signatures and phenotypes of tumor-infiltrating lymphocytes, including delineation of effector and regulatory T cells, and define T cell receptor (TCR) repertoire prior to and following entinostat treatment in TNBCs. We will also explore mutation and copy number variation status, and predicted major histocompatibility complex (MHC) class I neoantigen burden.
To document safety of entinostat in patients with TNBC prior to their scheduled surgical resection per National Cancer Institute - Common Terminology for Adverse Events (NCI-CTCAE v4.0).
- Conditions
- Breast Cancer, Invasive Breast Cancer, ER-Negative PR-Negative HER2-Negative Breast Cancer
- Being tested
- Entinostat
- Keywords
- Breast Cancer, ER Negative Breast Cancer, Triple Negative Breast Cancer, PR Negative Breast Cancer, ER Positive PR Positive Breast Cancer
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntinostatDrug
oral drug, 5mg tablet given once weekly x 2 doses
| Study group | Role | What they receive |
|---|---|---|
| Entinostat | Experimental | Nine days prior to their scheduled surgery, entinostat 5mg PO given once weekly on day 1 and day 8 Receives: Drug: Entinostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in Ki-67 mRNA following treatment with entinostat across TNBC breast cancers
RNA will be extracted from tumor samples using the Qiagen RNEasy Mini RNA extraction kit. mRNA-Seq libraries will made according to the Illumina TruSeq RNA Access protocol. Determination of molecular subtypes and relative expression of genes (i.e. Ki-67 as primary objective) and gene signatures from mRNA-seq data will be done. Change (decrease) in Ki-67 mRNA expression from will be measured by log2 fold-change in Ki-67 mRNA-seq expression from pre-treatment to post-treatment within each patient.
Measured: 9 days from start of entinostat (day of surgery)
Secondary outcomes (6)
mRNA gene expression changes following treatment with entinostat, across TNBC
RNA will be extracted from tumor samples using the Qiagen RNEasy Mini RNA extraction kit. mRNA-Seq libraries will made according to the Illumina TruSeq RNA Access protocol. Determination of molecular subtypes and relative expression of genes (i.e. Ki-67 as primary objective) and gene signatures from mRNA-seq data will be done. Expression of mRNA-seq will be measured in terms of relative standard error of the mean (RSEM) expected read counts after normalization by upper quartile normalization to adjust for between-sample differences in library sizes.
Measured: 9 days from start of entinostat (day of surgery)
Changes in the proliferation signature by mRNA expression following treatment with entinostat across TNBC
RNA will be extracted from tumor samples using the Qiagen RNEasy Mini RNA extraction kit. mRNA-Seq libraries will made according to the Illumina TruSeq RNA Access protocol. Determination of molecular subtypes and relative expression of genes (i.e. Ki-67 as primary objective) and gene signatures from mRNA-seq data will be done. Genes belonging to the proliferation signature will be individually examined and summarized by descriptive statistics.
Measured: 9 days from start of entinostat (day of surgery)
Differential kinome activation before and after treatment with entinostat across TNBC
Tissue samples for pre-treatment kinome analysis will be obtained from tissue remaining from the diagnostic, pre-treatment baseline biopsy (or from additional core needle biopsy of accessible tissue at study entry, if insufficient tissue is available from the diagnostic biopsy). Tissue samples for post-treatment kinome analysis will be obtained from the surgical procedure. A chemical proteomics approach will be employed to define the activity of a significant percentage of the expressed kinome in cells and tumors. Differential kinome activation will be measured in terms of the log2 fold change in MaxQuant Label Free Quantification (LFQ) intensity before and after treatment.
Measured: 9 days from start of entinostat (day of surgery)
Correlation of mutation and/or copy number variations by whole exome sequencing (WES) with mRNA gene expression changes and reduction of proliferation signature following treatment with entinostat across TNBC.
The T-cell receptor (TCR) repertoires of tumors and matched peripheral blood samples pre and post treatment with entinostat will be profiled, as well as the presence of dominant tumor-infiltrating clonotypes in the peripheral blood. RNA and whole-exome sequencing on tumor samples will be performed to capture molecular subtype, PD-L1 and other immune checkpoint molecule expression, immune gene signature and IPRES expression (ie, IPRES is a transcriptional signature associated with innate anti-PD-1 resistance) mutation and copy number variation status, and predicted MHC class I neoantigen burden. Continuous variables such as mRNA expression and DNA copy number will be assessed via Spearman Correlation, and correlation between categorical variables such as mutations and T-cell Phenotype will be assessed via Fisher's Exact Test.
Measured: 9 days from start of entinostat (day of surgery)
Correlation of protein lysine hyperacetylation in peripheral blood and tumor from pre- and post-entinostat treated TNBCs
Changes in protein lysine acetylation in blood mononuclear cells (PBMCs) will be assessed using an assay developed by the Trepel Laboratory, NCI/NIH. Pre to post-treatment change in protein lysine acetylation.will be measured in terms of the log2 fold change in MaxQuant LFQ intensity before and after treatment, and will be summarized with descriptive statistics
Measured: 9 days from start of entinostat (day of surgery)
Percentage of participants with treatment related adverse events
Any patient who receives at least one dose of entinostat on this protocol will be evaluable for toxicity, with toxicity evaluated using the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.
Safety assessments will consist of monitoring and reporting adverse events (AEs) and serious adverse events (SAEs) that are considered related to entinostat, all events of death, and any study specific issue of concern.
Measured: 30 days after treatment with entinostat
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start28 Nov 2018
- Primary completion18 Sep 2019
- Study completion11 Oct 2019
Why it stopped: Funding withdrawn.
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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Syndax Pharmaceuticals, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lisa Carey, MD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03361800
- Sponsor's protocol ID
- LCCC 1639
- Other IDs
- P50CA058223
- Status last verified
- Mar 2024
- First submitted
- 28 Nov 2017
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomized, Non-comparative, Open-label, Window Trial of Entinostat Given With or Without Exemestane in Patients With Newly Diagnosed, Stage I-IIIC, Hormone Receptor - Positive (HR+) or Triple Negative Breast Cancer (TNBC)
- ClinicalTrials.gov ID
- NCT03361800
- Acronym / sponsor ID
- LCCC 1639
- Conditions
- Breast Cancer, Invasive Breast Cancer, ER-Negative PR-Negative HER2-Negative Breast Cancer
- Keywords
- Breast Cancer, ER Negative Breast Cancer, Triple Negative Breast Cancer, PR Negative Breast Cancer, ER Positive PR Positive Breast Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding withdrawn.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Syndax Pharmaceuticals, National Cancer Institute (NCI)
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 18 Sep 2019 (actual)
- Study completion
- 11 Oct 2019 (actual)
- First posted
- 5 Dec 2017 (actual)
- 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.
This study is investigational and is not designed to treat cancer. In other words, the study drug, entinostat, is not being given to treat cancer. Instead, the study team is looking at the effects of entinostat on tumor tissue for research purposes only.
Approximately 246,660 cases of breast cancer were diagnosed in the United States in 2016. Its detection and treatment remains a major concern in women's healthcare. In particular, TNBC accounts for approximately 15-20% of all breast cancers. Research into treatment for breast cancer relies more and more on understanding how the cancer cells act when they are exposed to an anti-cancer drug. How most cancer cells act when exposed to anti-cancer drugs and which patients as a result may benefit the most from these drugs is not well known. Additional studies are required to determine the cells' reactions. The purpose of part 1 of this study is to better understand how TNBC tumors react to one particular cancer drug, entinostat. Entinostat is currently being studied across multiple clinical trials for the treatment of breast cancer, other solid tumors and blood cancers. Entinostat is investigational and has not yet been FDA approved for the treatment of cancer.
Studies have shown that a good way to determine how cancer acts when exposed to anti-cancer drugs is a short-term preoperative window study. In this type of study, subjects receive a study drug a couple of days before surgery. Leftover tissue from surgery is then used to determine some of the effects that a study drug may have on the tumor. In this study, subjects will receive two doses of entinostat prior to undergoing planned surgery. Leftover tissue from this surgery will then be used to determine the effects entinostat has on tumor cells. For example, the study team will examine if the types of genes and proteins that the tumor expresses as a result of entinostat exposure increases or decreases the likelihood that the tumor will not continue to grow. A gene is a unit of DNA. Genes make up the chemical structure carrying your genetic information that may determine human characteristics (i.e., eye color, height and sex). This study will focus on discovering how entinostat affects a wide variety of genes in tumor cells.
Detailed description
Primary Objective and Endpoint To identify decrease in Ki-67 mRNA following treatment with entinostat across TNBC breast cancers.
Secondary Objectives and Endpoints To identify messenger ribonucleic acid (mRNA) gene expression changes following treatment with entinostat, across TNBC.
To evaluate changes in the proliferation signature by mRNA expression following treatment with entinostat across TNBC.
To identify differential kinome activation before and after treatment with entinostat across TNBC
To correlate mutation and/or copy number variations by whole exome sequencing (WES) with mRNA gene expression changes and reduction of proliferation signature following treatment with entinostat across TNBC.
To correlate protein lysine hyperacetylation in peripheral blood and tumor from pre- and post-entinostat treated TNBCs.
To explore molecular subtype, Programmed death-ligand 1 (PD-L1) and other immune checkpoint molecule expression, immune gene and innate anti-programed cell death-1 resistance (IPRES) expression signatures and phenotypes of tumor-infiltrating lymphocytes, including delineation of effector and regulatory T cells, and define T cell receptor (TCR) repertoire prior to and following entinostat treatment in TNBCs. We will also explore mutation and copy number variation status, and predicted major histocompatibility complex (MHC) class I neoantigen burden.
To document safety of entinostat in patients with TNBC prior to their scheduled surgical resection per National Cancer Institute - Common Terminology for Adverse Events (NCI-CTCAE v4.0).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Entinostat | Experimental | Drug: EntinostatNine days prior to their scheduled surgery, entinostat 5mg PO given once weekly on day 1 and day 8 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Is female, age ≥ 18 years of age.
- For Part 1: Has histologically confirmed newly diagnosed Stage I-IIIC invasive breast cancer that is triple negative (ER/PR <1%, Her2 negative) and is scheduled to undergo definitive surgery (either lumpectomy, mastectomy) and meets the criteria listed below:
- For Part 2: Has histologically confirmed newly diagnosed Stage I-IIIC invasive breast cancer that is ER positive (+/- PR positive) and is scheduled to undergo definitive surgery (either lumpectomy, mastectomy) and meets the criteria listed below:
- Scheduled for lumpectomy or mastectomy and not considered a candidate for neoadjuvant systemic treatment b. No prior or current therapy for breast cancer c. Amenable to a baseline research breast biopsy
- Must have sufficient time to receive two doses of entinostat 7 days apart or exemestane for 8 consecutive days with or without entinostat prior to surgery.
Key exclusion criteria (16 listed)
- Stage IV breast cancer.
- Has clinically significant a) abnormal laboratory or ECG findings, b) history of myocardial infarction or arterial thromboembolic events within 6 months of screening or c) unstable angina, d) New York Heart Association (NYHA) Class III or IV disease or e) a corrected QT (QTc) interval > 470 msec.
- Medical history of uncontrolled hypertension (NCI CTCAE grade 3 or 4) or diabetes mellitus.
- Known active central nervous system metastases and/or carcinomatous meningitis.
- Prior history of another cancer within the previous 5 years with the exception of adequately treated basal cell carcinoma or cervical intraepithelial neoplasia, cervical carcinoma in situ or melanoma in situ.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Entinostatoral drug, 5mg tablet given once weekly x 2 doses | Drug | Entinostat |
Primary outcome
Decrease in Ki-67 mRNA following treatment with entinostat across TNBC breast cancers
Time frame: 9 days from start of entinostat (day of surgery)
RNA will be extracted from tumor samples using the Qiagen RNEasy Mini RNA extraction kit. mRNA-Seq libraries will made according to the Illumina TruSeq RNA Access protocol. Determination of molecular subtypes and relative expression of genes (i.e. Ki-67 as primary objective) and gene signatures from mRNA-seq data will be done. Change (decrease) in Ki-67 mRNA expression from will be measured by log2 fold-change in Ki-67 mRNA-seq expression from pre-treatment to post-treatment within each patient.
6 secondary outcomes
mRNA gene expression changes following treatment with entinostat, across TNBC
Time frame: 9 days from start of entinostat (day of surgery)
Changes in the proliferation signature by mRNA expression following treatment with entinostat across TNBC
Time frame: 9 days from start of entinostat (day of surgery)
Differential kinome activation before and after treatment with entinostat across TNBC
Time frame: 9 days from start of entinostat (day of surgery)
Correlation of mutation and/or copy number variations by whole exome sequencing (WES) with mRNA gene expression changes and reduction of proliferation signature following treatment with entinostat across TNBC.
Time frame: 9 days from start of entinostat (day of surgery)
Correlation of protein lysine hyperacetylation in peripheral blood and tumor from pre- and post-entinostat treated TNBCs
Time frame: 9 days from start of entinostat (day of surgery)
Percentage of participants with treatment related adverse events
Time frame: 30 days after treatment with entinostat
Results and safety
The study was stopped early (reason given: Funding withdrawn.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Lisa Carey, MD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Entinostat in people with Breast Cancer and Invasive 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 20 inclusion and 16 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: stopped early, as of the sponsor's last update on 25 Mar 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Funding withdrawn.). Results are not available in the source record.
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?
Decrease in Ki-67 mRNA following treatment with entinostat across TNBC breast cancers (time frame: 9 days from start of entinostat (day of surgery)). 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 25 Mar 2024.