Breast CancerPhase 1/2NCT07708194
Entinostat Plus Pyrotinib and Endocrine Therapy in Advanced Triple-Positive Breast Cancer After Trastuzumab Failure
A Phase 1/2 study testing entinostat, Pyrotinib and endocrine therapy in people with Breast Cancer and HER2-positive Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is an open-label, single-center, exploratory, Phase Ib/II clinical trial evaluating the safety and efficacy of entinostat combined with pyrotinib and endocrine therapy in patients with advanced hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-positive (HER2+) breast cancer who have… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer, HER2-positive Breast Cancer, Hormone Receptor-Positive Breast Cancer
- What is being tested?
- entinostat, Pyrotinib and endocrine therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 23 Jun 2025to Feb 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 75 years, female, premenopausal or postmenopausal.
- Histologically confirmed HR+/HER2+ breast cancer (HER2 positive defined as IHC 3+ or FISH confirmed by the pathology department of the study center).
- Histologically confirmed locally advanced breast cancer (not amenable to curative local therapy) or recurrent/metastatic breast cancer.
- Prior treatment with trastuzumab and taxane-based anticancer therapy.
- Received 1-2 prior lines of systemic anticancer therapy in the advanced setting.
- Life expectancy ≥ 3 months.
Show all 12Show fewer
- At least one measurable lesion per RECIST v1.1.
- ECOG performance status 0-2.
- All acute toxicities from prior anticancer therapy resolved to Grade 0-1 (per NCI CTCAE v5.0), except alopecia and toxicities deemed by the investigator to pose no safety risk.
- Adequate bone marrow function: ANC ≥ 1.5×10^9/L, platelet ≥ 100×10^9/L, hemoglobin ≥ 90 g/L.
- Adequate hepatic and renal function: TBIL ≤ 1.5×ULN; ALT and AST ≤ 2.5×ULN (or ≤ 5×ULN in the presence of liver metastases); BUN and Cr ≤ 1.5×ULN with creatinine clearance ≥ 50 mL/min.
- Voluntarily participate and sign written informed consent. -
Who cannot join
- Factors significantly affecting oral drug absorption, such as inability to swallow, chronic diarrhea, or intestinal obstruction.
- Prior treatment with any HDAC inhibitor for antitumor therapy.
- Prior or current use of any HER2-targeted tyrosine kinase inhibitor (including lapatinib, neratinib, pyrotinib, etc.).
- Known allergy to any component of the study drugs.
- Other malignancy within 5 years prior to enrollment, except cured papillary thyroid carcinoma, cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin.
- Participation in another drug clinical trial within 4 weeks prior to enrollment.
Show all 14Show fewer
- History of immunodeficiency, including HIV positivity, other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
- Uncontrolled significant cardiovascular disease: clinically significant QTc interval prolongation or QTc > 450 ms at screening; severe cardiac impairment (NYHA > Class II); unstable angina or myocardial infarction within 6 months; or severe arrhythmia.
- Pregnant or lactating women, or positive pregnancy test at baseline; or women of childbearing potential who are unwilling to use effective contraception during the study and for at least 8 weeks after the last dose.
- Concomitant diseases that, in the investigator's judgment, could seriously endanger patient safety or affect study completion (e.g., severe hypertension, diabetes, thyroid disease, active infection).
- Known history of neurological or psychiatric disorders, including epilepsy or dementia.
- Active hepatitis (HBV: HBsAg positive with HBV DNA ≥ 500 IU/mL; HCV: HCV antibody positive with HCV RNA > ULN).
- Any condition that, in the investigator's judgment, makes the patient unsuitable for study participation.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Yehui Shi, MD PhD, +86 23340123, ec_tjcih@126.com
About this study
Official title: An Open-Label, Single-Center, Exploratory Phase Ib/II Clinical Study of Entinostat Combined With Pyrotinib Plus Endocrine Therapy in Patients With Advanced Triple-Positive Breast Cancer After Trastuzumab Failure
This is an open-label, single-center, exploratory, Phase Ib/II clinical trial evaluating the safety and efficacy of entinostat combined with pyrotinib and endocrine therapy in patients with advanced hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-positive (HER2+) breast cancer who have failed prior trastuzumab-based therapy.
The study consists of two parts: Part I (Phase Ib) employs a 3+3 dose-escalation design to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended Phase II dose (RP2D) of entinostat when given in combination with pyrotinib (400 mg daily) and endocrine therapy. Part II (Phase II) uses a Simon two-stage design to further evaluate the efficacy and safety of the combination at the RP2D. The primary efficacy endpoint is progression-free survival (PFS) based on RECIST v1.1. A total of approximately 79-94 participants will be enrolled.
Read the detailed description
Background: Triple-positive breast cancer (TPBC), characterized by co-expression of HR and HER2, accounts for approximately 10% of all breast cancer cases. Despite the availability of anti-HER2 targeted therapies, patients with TPBC often have suboptimal responses to chemotherapy-containing regimens, and endocrine therapy resistance remains a clinical challenge. Histone deacetylase (HDAC) inhibitors have shown synergistic effects with HER2-targeted agents and endocrine therapy through epigenetic modulation, potentially reversing drug resistance and enhancing anti-tumor immunity.
Objective: To explore the DLT, MTD, and RP2D of entinostat in combination with pyrotinib and endocrine therapy, and to preliminarily evaluate the safety and efficacy of this regimen in HR+/HER2+ advanced breast cancer patients who have failed trastuzumab therapy.
Study Design: This is a two-part study. Part I (Phase Ib) is a single-arm, open-label, dose-escalation trial following the traditional 3+3 design. Entinostat is administered at escalating doses (3 mg, 4 mg, and 5 mg) once weekly, in combination with a fixed dose of pyrotinib (400 mg daily) and physician-selected endocrine therapy, in 28-day cycles. The DLT observation period is the first cycle.
Part II (Phase II) is a single-arm, two-stage (Simon's optimal design) trial. Participants will receive entinostat at the MTD/RP2D established in Part I, combined with pyrotinib (400 mg daily) and endocrine therapy. A total of 76 evaluable participants are planned for Part II, with an interim analysis after the first 24 participants. The study is expected to enroll approximately 79-94 participants over 24 months, with an additional 12 months of follow-up.
Key Eligibility: Female patients aged 18-75 years with histologically confirmed HR+/HER2+ locally advanced or metastatic breast cancer, who have received prior trastuzumab and taxane therapy, with 1-2 prior lines of systemic therapy in the advanced setting, ECOG PS 0-2, and measurable disease per RECIST v1.1.
Statistical Methods: PFS will be estimated using the Kaplan-Meier method. ORR, DCR, CBR, DoR, and PRO will be summarized with descriptive statistics and 95% confidence intervals. Safety data will be tabulated by type, severity, and relationship to study drugs.
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, Hormone Receptor-Positive Breast Cancer, Metastatic Breast Cancer
- Being tested
- entinostat, Pyrotinib, endocrine therapy
- Keywords
- Entinostat, Pyrotinib, HDAC Inhibitor, HER2-positive, Hormone Receptor-positive, Endocrine Therapy, Trastuzumab Resistance, Triple-positive Breast Cancer, Epigenetic Therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
entinostatDrug
Entinostat is an oral, selective class I histone deacetylase (HDAC) inhibitor, administered at 3 mg, 4 mg, or 5 mg once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, taken 60 minutes after a meal. The dose is determined by the 3+3 dose-escalation design in Part Ib.
PyrotinibDrug
Pyrotinib is an oral, irreversible pan-ErbB receptor tyrosine kinase inhibitor, administered at a fixed dose of 400 mg once daily, taken 30 minutes after a meal, in each 28-day cycle.
endocrine therapyDrug
Physician-selected endocrine therapy based on patient's prior treatment history and menopausal status. Options include tamoxifen (20 mg daily), aromatase inhibitors (letrozole 2.5 mg daily, anastrozole 1 mg daily, or exemestane 25 mg daily), or fulvestrant (500 mg intramuscularly on Days 1, 15, 29, and once monthly thereafter). For premenopausal patients, ovarian function suppression (OFS) with GnRH agonists is added. All endocrine agents are administered according to their approved package inserts.
| Study group | Role | What they receive |
|---|---|---|
| Entinostat + Pyrotinib + Endocrine Therapy | Experimental | Participants receive entinostat (weekly, oral), pyrotinib (400 mg daily, oral), and physician-selected endocrine therapy (tamoxifen, aromatase inhibitor, or fulvestrant; plus OFS for premenopausal patients) in 28-day cycles. Part Ib: dose-escalation of entinostat (3 mg, 4 mg, 5 mg) following the 3+3 design to determine MTD/RP2D. Part II: expansion at RP2D to evaluate efficacy and safety. Receives: Drug: entinostat; Drug: Pyrotinib; Drug: endocrine therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD), and Recommended Phase II Dose (RP2D) of Entinostat in Combination with Pyrotinib and Endocrine Therapy
DLT is assessed during the first 28-day cycle. MTD and RP2D are determined based on the 3+3 dose-escalation design.
Measured: Cycle 1 (Day 1 to Day 28)
Progression-Free Survival (PFS)
PFS is defined as the time from the first dose of study treatment to the first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first.
Measured: From first dose to disease progression or death, assessed up to 36 months
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
AEs and SAEs are graded according to NCI CTCAE v5.0, including hematological and non-hematological toxicities.
Measured: From signing of informed consent through 28 days after the last dose of study treatment
Secondary outcomes (6)
Objective Response Rate (ORR)
ORR is defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR) based on RECIST v1.1.
Measured: From first dose to disease progression, assessed up to 36 months
Disease Control Rate (DCR)
DCR is defined as the proportion of participants with a best overall response of CR, PR, or stable disease (SD) based on RECIST v1.1.
Measured: From first dose to disease progression, assessed up to 36 months
Clinical Benefit Rate (CBR)
CBR is defined as the proportion of participants with a best overall response of CR, PR, or SD lasting for at least 6 months based on RECIST v1.1.
Measured: From first dose to disease progression, assessed up to 36 months
Duration of Response (DoR)
DoR is defined as the time from the first documented CR or PR to the first documented disease progression per RECIST v1.1 or death from any cause.
Measured: From first documented response to disease progression or death, assessed up to 36 months
Overall Survival (OS)
OS is defined as the time from the first dose of study treatment to death from any cause.
Measured: From first dose to death from any cause, assessed up to 36 months
Patient-Reported Outcomes (PRO) - EORTC QLQ-C30
Health-related quality of life assessed using the EORTC QLQ-C30 (Version 3.0) Chinese version. The questionnaire includes functional scales, symptom scales, and global health status/QoL.
Measured: Baseline, every 2 cycles during treatment, and at end of treatment, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start23 Jun 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
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 Tianjin Medical University Cancer Institute and HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Taizhou EOC Pharma Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708194
- Sponsor's protocol ID
- CSIIT-C54
- Status last verified
- Jul 2026
- First submitted
- 12 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Center, Exploratory Phase Ib/II Clinical Study of Entinostat Combined With Pyrotinib Plus Endocrine Therapy in Patients With Advanced Triple-Positive Breast Cancer After Trastuzumab Failure
- ClinicalTrials.gov ID
- NCT07708194
- Acronym / sponsor ID
- CSIIT-C54
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, Hormone Receptor-Positive Breast Cancer, Metastatic Breast Cancer
- Keywords
- Entinostat, Pyrotinib, HDAC Inhibitor, HER2-positive, Hormone Receptor-positive, Endocrine Therapy, Trastuzumab Resistance, Triple-positive Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Taizhou EOC Pharma Co., Ltd.
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 16 Jul 2026 (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 is an open-label, single-center, exploratory, Phase Ib/II clinical trial evaluating the safety and efficacy of entinostat combined with pyrotinib and endocrine therapy in patients with advanced hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-positive (HER2+) breast cancer who have failed prior trastuzumab-based therapy.
The study consists of two parts: Part I (Phase Ib) employs a 3+3 dose-escalation design to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD), and recommended Phase II dose (RP2D) of entinostat when given in combination with pyrotinib (400 mg daily) and endocrine therapy. Part II (Phase II) uses a Simon two-stage design to further evaluate the efficacy and safety of the combination at the RP2D. The primary efficacy endpoint is progression-free survival (PFS) based on RECIST v1.1. A total of approximately 79-94 participants will be enrolled.
Detailed description
Background: Triple-positive breast cancer (TPBC), characterized by co-expression of HR and HER2, accounts for approximately 10% of all breast cancer cases. Despite the availability of anti-HER2 targeted therapies, patients with TPBC often have suboptimal responses to chemotherapy-containing regimens, and endocrine therapy resistance remains a clinical challenge. Histone deacetylase (HDAC) inhibitors have shown synergistic effects with HER2-targeted agents and endocrine therapy through epigenetic modulation, potentially reversing drug resistance and enhancing anti-tumor immunity.
Objective: To explore the DLT, MTD, and RP2D of entinostat in combination with pyrotinib and endocrine therapy, and to preliminarily evaluate the safety and efficacy of this regimen in HR+/HER2+ advanced breast cancer patients who have failed trastuzumab therapy.
Study Design: This is a two-part study. Part I (Phase Ib) is a single-arm, open-label, dose-escalation trial following the traditional 3+3 design. Entinostat is administered at escalating doses (3 mg, 4 mg, and 5 mg) once weekly, in combination with a fixed dose of pyrotinib (400 mg daily) and physician-selected endocrine therapy, in 28-day cycles. The DLT observation period is the first cycle.
Part II (Phase II) is a single-arm, two-stage (Simon's optimal design) trial. Participants will receive entinostat at the MTD/RP2D established in Part I, combined with pyrotinib (400 mg daily) and endocrine therapy. A total of 76 evaluable participants are planned for Part II, with an interim analysis after the first 24 participants. The study is expected to enroll approximately 79-94 participants over 24 months, with an additional 12 months of follow-up.
Key Eligibility: Female patients aged 18-75 years with histologically confirmed HR+/HER2+ locally advanced or metastatic breast cancer, who have received prior trastuzumab and taxane therapy, with 1-2 prior lines of systemic therapy in the advanced setting, ECOG PS 0-2, and measurable disease per RECIST v1.1.
Statistical Methods: PFS will be estimated using the Kaplan-Meier method. ORR, DCR, CBR, DoR, and PRO will be summarized with descriptive statistics and 95% confidence intervals. Safety data will be tabulated by type, severity, and relationship to study drugs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Entinostat + Pyrotinib + Endocrine Therapy | Experimental | Drug: entinostat, Drug: Pyrotinib, Drug: endocrine therapyParticipants receive entinostat (weekly, oral), pyrotinib (400 mg daily, oral), and physician-selected endocrine therapy (tamoxifen, aromatase inhibitor, or fulvestrant; plus OFS for premenopausal patients) in 28-day cycles. Part Ib: dose-escalation of entinostat (3 mg, 4 mg, 5 mg) following the 3+3 design to determine MTD/RP2D. Part II: expansion at RP2D to evaluate efficacy and safety. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 and ≤ 75 years, female, premenopausal or postmenopausal.
- Histologically confirmed HR+/HER2+ breast cancer (HER2 positive defined as IHC 3+ or FISH confirmed by the pathology department of the study center).
- Histologically confirmed locally advanced breast cancer (not amenable to curative local therapy) or recurrent/metastatic breast cancer.
- Prior treatment with trastuzumab and taxane-based anticancer therapy.
- Received 1-2 prior lines of systemic anticancer therapy in the advanced setting.
Key exclusion criteria (14 listed)
- Factors significantly affecting oral drug absorption, such as inability to swallow, chronic diarrhea, or intestinal obstruction.
- Prior treatment with any HDAC inhibitor for antitumor therapy.
- Prior or current use of any HER2-targeted tyrosine kinase inhibitor (including lapatinib, neratinib, pyrotinib, etc.).
- Known allergy to any component of the study drugs.
- Other malignancy within 5 years prior to enrollment, except cured papillary thyroid carcinoma, cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin.
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 |
|---|---|---|
| entinostatEntinostat is an oral, selective class I histone deacetylase (HDAC) inhibitor, administered at 3 mg, 4 mg, or 5 mg once weekly on Days 1, 8, 15, and 22 of each 28-day cycle, taken 60 minutes after a meal. The dose is determined by the 3+3 dose-escalation design in Part Ib. | Drug | Entinostat + Pyrotinib + Endocrine Therapy |
| PyrotinibPyrotinib is an oral, irreversible pan-ErbB receptor tyrosine kinase inhibitor, administered at a fixed dose of 400 mg once daily, taken 30 minutes after a meal, in each 28-day cycle. | Drug | Entinostat + Pyrotinib + Endocrine Therapy |
| endocrine therapyPhysician-selected endocrine therapy based on patient's prior treatment history and menopausal status. Options include tamoxifen (20 mg daily), aromatase inhibitors (letrozole 2.5 mg daily, anastrozole 1 mg daily, or exemestane 25 mg daily), or fulvestrant (500 mg intramuscularly on Days 1, 15, 29, and once monthly thereafter). For premenopausal patients, ovarian function suppression (OFS) with GnRH agonists is added. All endocrine agents are administered according to their approved package inserts. | Drug | Entinostat + Pyrotinib + Endocrine Therapy |
Primary outcome
Dose-Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD), and Recommended Phase II Dose (RP2D) of Entinostat in Combination with Pyrotinib and Endocrine Therapy
Time frame: Cycle 1 (Day 1 to Day 28)
DLT is assessed during the first 28-day cycle. MTD and RP2D are determined based on the 3+3 dose-escalation design.
Progression-Free Survival (PFS)
Time frame: From first dose to disease progression or death, assessed up to 36 months
PFS is defined as the time from the first dose of study treatment to the first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first.
Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From signing of informed consent through 28 days after the last dose of study treatment
AEs and SAEs are graded according to NCI CTCAE v5.0, including hematological and non-hematological toxicities.
6 secondary outcomes
Objective Response Rate (ORR)
Time frame: From first dose to disease progression, assessed up to 36 months
Disease Control Rate (DCR)
Time frame: From first dose to disease progression, assessed up to 36 months
Clinical Benefit Rate (CBR)
Time frame: From first dose to disease progression, assessed up to 36 months
Duration of Response (DoR)
Time frame: From first documented response to disease progression or death, assessed up to 36 months
Overall Survival (OS)
Time frame: From first dose to death from any cause, assessed up to 36 months
Patient-Reported Outcomes (PRO) - EORTC QLQ-C30
Time frame: Baseline, every 2 cycles during treatment, and at end of treatment, assessed up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing entinostat, Pyrotinib and endocrine therapy in people with Breast Cancer and HER2-positive Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
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 12 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 16 Jul 2026. 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 China. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yehui Shi, MD, PhD (+86 18622221183, shiyehui@tjmuch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD), and Recommended Phase II Dose (RP2D) of Entinostat in Combination with Pyrotinib and Endocrine Therapy (time frame: Cycle 1 (Day 1 to Day 28)). The study lists 3 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 16 Jul 2026.