Estrogen Receptor-negative Breast CancerPhase 20927GCCNCT01234532
Entinostat and Anastrozole in Treating Postmenopausal Women With TNBC That Can Be Removed by Surgery
A Phase 2 study testing entinostat, anastrozole and diagnostic laboratory biomarker analysis in people with Estrogen Receptor-negative Breast Cancer and HER2-negative Breast Cancer, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
This phase II trial is studying how well giving entinostat and anastrozole together works in treating postmenopausal women with triple-negative breast cancer that can be removed by surgery. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Estrogen Receptor-negative Breast Cancer, HER2-negative Breast Cancer, Progesterone Receptor-negative Breast Cancer
- What is being tested?
- entinostat, anastrozole and diagnostic laboratory biomarker analysis
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to May 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Female greater than or equal to 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status <2 (see Appendix A).
- Histologically confirmed adenocarcinoma of the breast.
- Evidence of hormone insensitivity (ER and PR negative) of primary tumor tissue. ER negative is define as ER 0 or < 1% staining by immunohistochemistry. PR negativity is defined as PR < 1% staining by immunohistochemistry.
- HER2 negative in the primary tumor tissue as defined by:
- Immunohistochemistry (IHC) Grade 0 as defined by no staining observed or membrane staining that is incomplete and is faint/barely perceptible and within ≤10% of the invasive tumor cell
Show all 39Show fewer
- IHC 1+ as defined by incomplete membrane staining that is faint/barely perceptible and within >10% of the invasive tumor cell
- IHC Grade 2+ staining intensity by means of IHC analysis with no gene amplification below.
- No gene amplification on ISH based on
- Single-probe average HER2 copy number <4.0 signals/cell
- Dual-probe HER2/CEP17 ratio <2.0 with an average HER2 copy number <4.0 signals/cell
- Ability to understand and the willingness to sign a written informed consent document.
- Patients must not have received any prior chemotherapy, radiation therapy, or endocrine therapy for their current breast cancer. Patients who received tamoxifen or raloxifene or another agent for prevention of breast cancer may be included as long as the patient has discontinued the treatment at least one month prior to baseline study biopsy.
- Women of childbearing potential must have negative (serum or urine) pregnancy test within 7 days prior to registration.
- Patients must have adequate tumor tissue sample prior to the enrolment available for correlative studies as defined below:
- Core needle biopsy or incisional biopsy samples that can provide ≥ 3 unstained sections of 5 micron thickness. Fine needle aspiration (FNA) sample alone is not sufficient except in the second cohort.
- Additional core needle biopsy needs to be performed in the patients who agree to participate in this study and do not have adequate tumor tissue sample.
- Patients must have adequate organ and marrow function as defined below:
- Hemoglobin ≥ 9.0 g/dL
- Leukocytes >2,500/mcL
- Absolute neutrophil count >1,100/mcL
- Platelets >100,000/mcL
- Total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) <2.5 x institutional upper limit of normal
- Creatinine within normal institutional limits or creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal
- Additional Inclusion Criteria for the First cohort:
- Unresected operable breast cancer that meets the following clinical stages (see Appendix B):
- T1b, T1c, or T2
- N0 or N1
- M0 (No distant metastasis)
- Additional Inclusion Criteria for the Second cohort:
- Unresectable, inoperable, recurrent local-regional breast cancer or
- Metastatic (stage IV) breast cancer
- Patients must have measurable or evaluable disease (i.e. ascites or pleural/pericardial effusion). Patients with bone metastatic only will be excluded.
- Patients must not have rapidly progressive disease, extensive visceral involvement, or any high risk characteristics that are not appropriate for this treatment as per investigator's discretion.
- Patients must receive at least one prior line of chemotherapy but not more 2 prior chemotherapy regimens for stage IV breast cancer. Prior chemotherapy in the adjuvant and /or neoadjuvant setting is permitted. However, patients must have finished chemotherapy at least 2 weeks prior to enrollment.
- Patients must have an accessible tumor lesion from which a fine needle aspirate or preferably a core biopsy specimen can be obtained. Patients with FNA only samples are allowed in this cohort. Ascites or pleural/pericardial effusion alone is not sufficient.
- Patients must be willing to provide consents for 2 research biopsies. However, the pretreatment biopsy can be omitted in patients who have recent biopsy but have not been started on breast cancer treatment within 12 weeks prior to the registration and there is adequate tumor tissue sample
- Women of all races and ethnic groups are eligible for this trial.
Who cannot join
- Patients may not be receiving any other investigational agents.
- Prior exposure to other HDAC inhibitors. However, prior valproic acid exposure is allowed providing
- ≥ 30 days wash-out period.
- History of allergic reactions or hypersensitivity to compounds of similar chemical or biologic composition to entinostat, benzamide, anastrozole, or tamoxifen.
- Any medical condition which in the opinion of the investigator puts the patient at risk of potentially serious complications while on this therapy. Examples: HIV, unstable angina, uncontrolled heart failure or hypertension, uncontrolled hyperlipidemia, uncontrolled diabetes mellitus, uncontrolled systemic infection.
- Previous or current systemic malignancy within the past 3 years other than breast cancer or adequately treated cervical carcinoma in situ or basal/squamous carcinoma of the skin.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Baltimore
Baltimore, Maryland, 21201
About this study
Official title: GCC 0927 A Pilot and Phase II Study of Entinostat and Anastrozole/Tamoxifen in Women With Triple Negative Breast Cancer to Evaluate Biomarkers and Surrogates for Response
This phase II trial is studying how well giving entinostat and anastrozole together works in treating postmenopausal women with triple-negative breast cancer that can be removed by surgery. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving entinostat together with anastrozole may be an effective treatment for breast cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the safety and tolerability of entinostat in combination with anastrozole or tamoxifen. (Pilot) II. To determine the optimal dose of entinostat in combination with anastrozole or tamoxifen for phase II. (Pilot) III. To determine baseline and percentage change in proliferative index (Ki67) before and after treatment with entinostat and anastrozole/tamoxifen in triple negative breast cancer (TNBC). (Phase II) IV. To determine the estrogen receptor (ER) expression after treatment with entinostat and anastrozole/tamoxifen in TNBC. (Phase II)
SECONDARY OBJECTIVES:
- To evaluate baseline and change in the expression levels of progesterone receptor (PR), human epidermal growth factor receptor 2 (HER2), epidermal growth factor receptor (EGFR), cytokeratin 5/6 (CK5/6), and aromatase before and after treatment with entinostat and anastrozole/tamoxifen.
II. To assess baseline and change in tumor tissue histone H3 and H4 acetylation before and after treatment with entinostat and anastrozole/tamoxifen.
III. To assess the clinical and pathological response to preoperative combination of entinostat and anastrozole/tamoxifen in TNBC.
TERTIARY OBJECTIVES:
- To correlate the levels of histone H3 and H4 acetylation in tumors with the changes in Ki67 and ER.
II. To evaluate baseline and change in gene methylation silencing and expression of candidate genes in tissues and in circulating DNA, including estrogen receptor (ER)-alpha, ER-beta, RAR-beta, cyclin D2, Twist, RASSF1A, and HIN-1.
III. To correlate entinostat trough concentrations with histone H3 and H4 acetylation in tumors as well as the change in Ki67 and ER.
IV. To evaluate baseline and change in the global gene expression profile before and after treatment with entinostat and anastrozole/tamoxifen.
OUTLINE: This is a multicenter, pilot study followed by a phase II study.
Patients receive entinostat orally (PO) once daily on days 1, 8, 15, 22, and 29 and anastrozole PO once daily on days 4-29. Patients then undergo mastectomy or lumpectomy.
Tumor tissue samples are collected at baseline or from original diagnosis, and during surgery for correlative studies by IHC and RT-PCR. Blood samples are also collected at baseline, on days 1 and 15, and during surgery for correlative studies.
After completion of study therapy, patients are followed up for 30 days.
- Conditions
- Estrogen Receptor-negative Breast Cancer, HER2-negative Breast Cancer, Progesterone Receptor-negative Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer
- Being tested
- entinostat, anastrozole, diagnostic laboratory biomarker analysis, therapeutic conventional surgery
- 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
Also called SNDX-275, MS-275
orally
anastrozoleDrug
Also called arimidex
Given PO
diagnostic laboratory biomarker analysisOther
Correlative studies will be performed utilizing tissue and blood. A baseline tumor biopsy is done prior to study entry or archival tissue from diagnosis may be used and a representative tumor sample is submitted at time of surgery.
Bloods are drawn for correlative sciences on day 1 and 15 of treatment prior to entinostat dosing and 30 mins post and again on day of surgery.
therapeutic conventional surgeryProcedure or surgery
Also called Lumpectomy or mastectomy
Lumpectomy or mastectomy will be performed follwoing day 29 of study therapy
| Study group | Role | What they receive |
|---|---|---|
| entinostat & anastrozole neoadjuvant | Experimental | Neoadjuvant entinostat daily on days 1, 8, 15, 22, and 29 + anastrozole daily on days 4-29 followed by surgery ie either lumpectomy or mastectomy.
Correlative studies will be performed utilizing tissue and blood. A baseline tumor biopsy is done prior to study entry or archival tissue from diagnosis may be used and a representative tumor sample is submitted at time of surgery.
Bloods are drawn for correlative sciences on day 1 and 15 of treatment prior to entinostat dosing and 30 mins post and again on day of surgery. Receives: Drug: entinostat; Drug: anastrozole; Other: diagnostic laboratory biomarker analysis; Procedure: therapeutic conventional surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Phase II Dose of Entinostat in Combination With Anastrozole (Pilot)
Since the study was terminated early there was insufficient data for analysis and to recommend a phase II dose of entinostat in combination with anastrozole
Measured: Duration of the study is 29 days followed by 30 days end of study assessment visit, up to 59 days
Number of Participants With Adverse Events
To address the safety of the regimen, a maximum width 90% confidence interval for any grade 3 or higher toxicity will be approximately 30%. For 5 patients in this study, if the true unknown probability of a rare toxicity is 10%, the probability of observing 1 or more toxicities is 97%, and if the true toxicity rate is 5% then the probability of observing one or more rare toxicities is 83%.
Measured: Participants were followed during the study and for 30 days post treatment, up to 59 days
Change in Proliferative Index (Ki67) (Phase II)
The 95% confidence intervals will be constructed for the observed proportions. Exploratory data analysis and appropriate graphs will be used to decide whether data transformation (e.g. log or square-root) is necessary to assure an approximate normality. All descriptive statistics will be reported for ER and Ki67 expression. The general linear model approach and/or its non parametric alternative, the Wilcoxon test, will be used to assess whether there is any evidence of changes due to treatment.
Measured: Baseline to the time of surgery, within 6 days after the last dose of entinostat, up to 35 days
Change in Estrogen-receptor (ER) Expression (Phase II)
The 95% confidence intervals will be constructed for the observed proportions. Exploratory data analysis and appropriate graphs will be used to decide whether data transformation (e.g. log or square-root) is necessary to assure an approximate normality. All descriptive statistics will be reported for ER and Ki67 expression. The general linear model approach and/or its non parametric alternative, the Wilcoxon test, will be used to assess whether there is any evidence of changes due to treatment.
Measured: Baseline before the study treatment and at the time of surgery, up to 30 days
Secondary outcomes (3)
Clinical Response to Entinostat and Anastrozole
Rate of clinical response % of patients responding
Measured: Clinical response was assessed during the study treatment and before the surgery, up to 29 days
Change in HER2
Will be treated as continuous variables. Multivariate analysis of variance may also be used to compare correlated biomarkers' expression. Correlation between biomarkers will be estimated and tested. The repeated measures model approach will be also used. Categorical outcome data (e.g., number of proteins expressed) will be recorded, proportions will be estimated and compared using the Fisher's exact test.
Measured: Baseline before study treatment and at the time of surgery, up to 30 days
The Pathological Response to Entinostat and Anastrozole
Rate of Pathologic response % of patients responding
Measured: Pathological response was assessed after the surgery, up to 59 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionMay 2017
- Study completionMay 2017
Why it stopped: low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Estrogen Receptor-negative Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- no masking
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- Syndax Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Saranya Chumsri, Principal investigator, University of Chicago Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234532
- Sponsor's protocol ID
- HP-00047658
- Other IDs
- NCI-2011-02542, CDR0000687507, 8597
- Acronym
- 0927GCC
- Status last verified
- Apr 2022
- First submitted
- 3 Nov 2010
- Last updated
- 3 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GCC 0927 A Pilot and Phase II Study of Entinostat and Anastrozole/Tamoxifen in Women With Triple Negative Breast Cancer to Evaluate Biomarkers and Surrogates for Response
- ClinicalTrials.gov ID
- NCT01234532
- Acronym / sponsor ID
- 0927GCC / HP-00047658
- Conditions
- Estrogen Receptor-negative Breast Cancer, HER2-negative Breast Cancer, Progesterone Receptor-negative Breast Cancer, Stage I Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- Syndax Pharmaceuticals
- Study start
- Oct 2010
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 4 Nov 2010 (estimated)
- Results
- Posted 3 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial is studying how well giving entinostat and anastrozole together works in treating postmenopausal women with triple-negative breast cancer that can be removed by surgery. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving entinostat together with anastrozole may be an effective treatment for breast cancer.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the safety and tolerability of entinostat in combination with anastrozole or tamoxifen. (Pilot) II. To determine the optimal dose of entinostat in combination with anastrozole or tamoxifen for phase II. (Pilot) III. To determine baseline and percentage change in proliferative index (Ki67) before and after treatment with entinostat and anastrozole/tamoxifen in triple negative breast cancer (TNBC). (Phase II) IV. To determine the estrogen receptor (ER) expression after treatment with entinostat and anastrozole/tamoxifen in TNBC. (Phase II)
SECONDARY OBJECTIVES:
- To evaluate baseline and change in the expression levels of progesterone receptor (PR), human epidermal growth factor receptor 2 (HER2), epidermal growth factor receptor (EGFR), cytokeratin 5/6 (CK5/6), and aromatase before and after treatment with entinostat and anastrozole/tamoxifen.
II. To assess baseline and change in tumor tissue histone H3 and H4 acetylation before and after treatment with entinostat and anastrozole/tamoxifen.
III. To assess the clinical and pathological response to preoperative combination of entinostat and anastrozole/tamoxifen in TNBC.
TERTIARY OBJECTIVES:
- To correlate the levels of histone H3 and H4 acetylation in tumors with the changes in Ki67 and ER.
II. To evaluate baseline and change in gene methylation silencing and expression of candidate genes in tissues and in circulating DNA, including estrogen receptor (ER)-alpha, ER-beta, RAR-beta, cyclin D2, Twist, RASSF1A, and HIN-1.
III. To correlate entinostat trough concentrations with histone H3 and H4 acetylation in tumors as well as the change in Ki67 and ER.
IV. To evaluate baseline and change in the global gene expression profile before and after treatment with entinostat and anastrozole/tamoxifen.
OUTLINE: This is a multicenter, pilot study followed by a phase II study.
Patients receive entinostat orally (PO) once daily on days 1, 8, 15, 22, and 29 and anastrozole PO once daily on days 4-29. Patients then undergo mastectomy or lumpectomy.
Tumor tissue samples are collected at baseline or from original diagnosis, and during surgery for correlative studies by IHC and RT-PCR. Blood samples are also collected at baseline, on days 1 and 15, and during surgery for correlative studies.
After completion of study therapy, patients are followed up for 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- no masking
| Arm | Type | Receives |
|---|---|---|
| entinostat & anastrozole neoadjuvant | Experimental | Drug: entinostat, Drug: anastrozole, Other: diagnostic laboratory biomarker analysis, Procedure: therapeutic conventional surgeryNeoadjuvant entinostat daily on days 1, 8, 15, 22, and 29 + anastrozole daily on days 4-29 followed by surgery ie either lumpectomy or mastectomy. Correlative studies will be performed utilizing tissue and blood. A baseline tumor biopsy is done prior to study entry or archival tissue from diagnosis may be used and a representative tumor sample is submitted at time of surgery. Bloods are drawn for correlative sciences on day 1 and 15 of treatment prior to entinostat dosing and 30 mins post and again on day of surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (39 listed)
- Female greater than or equal to 18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status <2 (see Appendix A).
- Histologically confirmed adenocarcinoma of the breast.
- Evidence of hormone insensitivity (ER and PR negative) of primary tumor tissue. ER negative is define as ER 0 or < 1% staining by immunohistochemistry. PR negativity is defined as PR < 1% staining by immunohistochemistry.
- HER2 negative in the primary tumor tissue as defined by:
Key exclusion criteria (6 listed)
- Patients may not be receiving any other investigational agents.
- Prior exposure to other HDAC inhibitors. However, prior valproic acid exposure is allowed providing
- ≥ 30 days wash-out period.
- History of allergic reactions or hypersensitivity to compounds of similar chemical or biologic composition to entinostat, benzamide, anastrozole, or tamoxifen.
- Any medical condition which in the opinion of the investigator puts the patient at risk of potentially serious complications while on this therapy. Examples: HIV, unstable angina, uncontrolled heart failure or hypertension, uncontrolled hyperlipidemia, uncontrolled diabetes mellitus, uncontrolled systemic infection.
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 |
|---|---|---|
| entinostatAlso: SNDX-275, MS-275orally | Drug | entinostat & anastrozole neoadjuvant |
| anastrozoleAlso: arimidexGiven PO | Drug | entinostat & anastrozole neoadjuvant |
| diagnostic laboratory biomarker analysisCorrelative studies will be performed utilizing tissue and blood. A baseline tumor biopsy is done prior to study entry or archival tissue from diagnosis may be used and a representative tumor sample is submitted at time of surgery. Bloods are drawn for correlative sciences on day 1 and 15 of treatment prior to entinostat dosing and 30 mins post and again on day of surgery. | Other | entinostat & anastrozole neoadjuvant |
| therapeutic conventional surgeryAlso: Lumpectomy or mastectomyLumpectomy or mastectomy will be performed follwoing day 29 of study therapy | Procedure or surgery | entinostat & anastrozole neoadjuvant |
Primary outcome
Recommended Phase II Dose of Entinostat in Combination With Anastrozole (Pilot)
Time frame: Duration of the study is 29 days followed by 30 days end of study assessment visit, up to 59 days
Since the study was terminated early there was insufficient data for analysis and to recommend a phase II dose of entinostat in combination with anastrozole
Number of Participants With Adverse Events
Time frame: Participants were followed during the study and for 30 days post treatment, up to 59 days
To address the safety of the regimen, a maximum width 90% confidence interval for any grade 3 or higher toxicity will be approximately 30%. For 5 patients in this study, if the true unknown probability of a rare toxicity is 10%, the probability of observing 1 or more toxicities is 97%, and if the true toxicity rate is 5% then the probability of observing one or more rare toxicities is 83%.
Change in Proliferative Index (Ki67) (Phase II)
Time frame: Baseline to the time of surgery, within 6 days after the last dose of entinostat, up to 35 days
The 95% confidence intervals will be constructed for the observed proportions. Exploratory data analysis and appropriate graphs will be used to decide whether data transformation (e.g. log or square-root) is necessary to assure an approximate normality. All descriptive statistics will be reported for ER and Ki67 expression. The general linear model approach and/or its non parametric alternative, the Wilcoxon test, will be used to assess whether there is any evidence of changes due to treatment.
Change in Estrogen-receptor (ER) Expression (Phase II)
Time frame: Baseline before the study treatment and at the time of surgery, up to 30 days
The 95% confidence intervals will be constructed for the observed proportions. Exploratory data analysis and appropriate graphs will be used to decide whether data transformation (e.g. log or square-root) is necessary to assure an approximate normality. All descriptive statistics will be reported for ER and Ki67 expression. The general linear model approach and/or its non parametric alternative, the Wilcoxon test, will be used to assess whether there is any evidence of changes due to treatment.
3 secondary outcomes
Clinical Response to Entinostat and Anastrozole
Time frame: Clinical response was assessed during the study treatment and before the surgery, up to 29 days
Change in HER2
Time frame: Baseline before study treatment and at the time of surgery, up to 30 days
The Pathological Response to Entinostat and Anastrozole
Time frame: Pathological response was assessed after the surgery, up to 59 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Saranya Chumsri principal investigator
University of Chicago 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 Phase 2 study testing entinostat, anastrozole and diagnostic laboratory biomarker analysis in people with Estrogen Receptor-negative Breast Cancer and HER2-negative Breast Cancer, run by University of Maryland, Baltimore 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 39 inclusion and 6 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 3 May 2022. 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?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Recommended Phase II Dose of Entinostat in Combination With Anastrozole (Pilot) (time frame: Duration of the study is 29 days followed by 30 days end of study assessment visit, up to 59 days). The study lists 4 primary outcomes in all. 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 3 May 2022.