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Locally Advanced or Metastatic Breast CancerPhase 2NCT07235618

A Study of Entinostat in Combination With Fulvestrant for the Treatment of Locally Advanced or Metastatic Breast Cancer

A Phase 2 study testing Entinostat and Fulvestrant in people with Locally Advanced or Metastatic Breast Cancer, run by Sun Yat-sen University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study aims to evaluate the efficacy of Entinostat combined with Fulvestrant in HR+/HER2- advanced breast cancer patients with recurrence/progression after endocrine therapy (primary endpoint: progression-free survival [PFS]), and explore the correlation between peripheral blood mononuclear cell (PBMC) acetylation… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
Entinostat and Fulvestrant
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
5 Jan 2026to 30 Dec 2028
Phase
Phase 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

  • Signed informed consent form.
  • Female participants aged ≥18 and ≤75 years. 3 .Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  • 4. Life expectancy ≥3 months. 5.Participants must have histopathologically and molecular pathologically diagnosised HR-positive and HER2-negative breast cancer (based on the most recent report),defined as presence of following criteria:
  • . Hormone receptor positivity is defined by the presence of estrogen receptors (ER), where a threshold of ≥10% positive staining cells is considered indicative of positivity. The status of progesterone receptors (PR) can be either negative or positive, with the same criterion of ≥10% positive staining cells applied to determine receptor positivity.
  • . HER-2 negativity indicates that the immunohistochemical assessment of the pathological specimen yields a result classified as 0 or 1+. Alternatively, a result classified as 2+ may also be deemed HER-2 negative if corroborated by negative findings from ISH or FISH testing.
  • 6. Participants must have received endocrine +CDK4/6 inhibitor treatment and meet any of the following conditions, namely endocrine resistance:
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  • Imaging progression occurs during adjuvant/neoadjuvant endocrine therapy; or b) Recurrence/metastasis within ≤12 months after the completion of adjuvant endocrine therapy; or c) Disease progression occurred after first-line endocrine therapy in the advanced stage (RECIST v1.1).
  • 7.Prior chemotherapy history for the participants must meet:
  • For metastatic diseases, having received ≤1 line of chemotherapy (including antibody-drug conjugates) in the past;
  • The period from the end of the last chemotherapy administration to the randomization date is ≥4 weeks;
  • If disease progression occurs within ≤12 months after the end of neoadjuvant or adjuvant chemotherapy, this regimen is regarded as first-line chemotherapy in the metastasis stage.
  • 8.One week (7 days) before the start of the study administration, the participant must have adequate organ function, as defined below: Hematology: Hemoglobin (HgB) ≥80 g/L, platelet count ≥50×109 /L, absolute neutrophil count ≥1.0×109 /L.
  • Note: Before these laboratory tests, platelet transfusion is not allowed within 3 days, red blood cell transfusion is not allowed within 14 days, and hematopoietic growth factor (pegylated G-CSF and erythropoietin within 14 days) is not allowed within 7 days.
  • Renal function: Serum creatinine (Cre) ≤1.5× upper limit of normal (ULN), or glomerular filtration rate (eGFR) ≥60 mL/min/1.73m2.
  • Liver function: Total bilirubin ≤1.5×ULN; If Gilbert syndrome is present, the total bilirubin is ≤3 mg/dL. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN; If there is liver metastasis, both ALT and AST should be ≤5×ULN. Alkaline phosphatase (ALP) ≤2.5×ULN; If there is bone metastasis, it should be ≤5×ULN.
  • 9.Left ventricular ejection fraction (LVEF) ≥50% by echocardiogram and QTc interval ≤480 ms.
  • 10.Female participants in the premenopausal or perimenopausal stages who consent to the use of concomitant luteinizing hormone-releasing hormone (LHRH) agonists are eligible for enrollment. Participants meeting any of the following criteria may be classified as having reached menopause; those not fulfilling these criteria will be considered to be in the premenopausal or perimenopausal period:
  • 1)- A history of bilateral oophorectomy; 2）- Age ≥ 60 years; 3）- Age < 60 years, with natural amenorrhea lasting ≥ 12 months, during which no chemotherapy, tamoxifen, torremifene, or ovarian castration was administered. Additionally, blood levels of follicle-stimulating hormone (FSH) and estradiol (E2) must fall within the postmenopausal range (as determined in conjunction with the reference range established by the research center); 11.Participants of childbearing potential must use effective contraception (e.g., spermicidal condoms, vaginal diaphragm, oral/injectable contraceptives) or practice abstinence during and for 3 months after treatment.

Who cannot join

  • Presence of current or prior Central Nervous System (CNS) metastases or leptomeningeal disease (LMD).
  • Prior treatment with Selective Estrogen Receptor Degraders (SERD, e.g., fulvestrant) or Histone Deacetylase (HDAC) inhibitors (e.g., entinostat, chidamide).
  • Known to be allergic to SERD, entinostat or other drugs with a benzamide structure (such as tyapride, remopilib, cloprapride, etc.).
  • Pregnant or lactating women.
  • Combined with other malignant tumors, unless radical treatment has been carried out and there is no evidence of recurrence or metastasis;
  • Clinically significant effusions requiring drainage (e.g., pericardial, pleural, or ascites with symptoms).
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  • Significant clinical gastrointestinal dysfunction that may affect oral medication intake, transport, or absorption(e.g., dysphagia, chronic diarrhea, intestinal obstruction).
  • Severe infectious diseases, uncontrolled or severe cardiovascular diseases, or other abnormalities within 14 days before enrollment that the investigators considered might affect the safety and compliance of the subjects and were not suitable for participation in this clinical trial.
  • Participants deemed by investigators as unsuitable for endocrine therapy.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shusen Wang, MD contact

+86-02087342491

wangshs@sysucc.org.cn

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

    Qiufan Zheng, MD, +8602087342491, zhengqf@sysucc.org.cn

    wangshs@sysucc.org.cn

Other trials in China

About this study

Official title: A Phase II, Two-Stage Study Evaluating the Efficacy of Entinostat in Combined With Fulvestrant in Locally Advanced or Metastatic Breast Cancer With Recurrence or Progression After CDK4/6 Inhibitor Plus Endocrine Therapy

This study aims to evaluate the efficacy of Entinostat combined with Fulvestrant in HR+/HER2- advanced breast cancer patients with recurrence/progression after endocrine therapy (primary endpoint: progression-free survival [PFS]), and explore the correlation between peripheral blood mononuclear cell (PBMC) acetylation levels and treatment response to determine the baseline acetylation threshold .

Being tested
Entinostat, Fulvestrant
Keywords
Locally Advanced or Metastatic Breast Cancer, Entinostat, Fulvestrant, HR positive and HER2 negtive
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 (5mg/week, po)

  • FulvestrantDrug

    Fulvestrant( 500 mg intramuscularly on Days 1 and 15 of Cycle 1, and then on Day 1 of each subsequent 28-day cycle)

Study groups in NCT07235618
Study groupRoleWhat they receive
Entinostat + FulvestrantExperimentalNot described
Receives: Drug: Entinostat; Drug: Fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)

    Progression-free survival(PFS) is defined as the time from treatment initiation to disease progression or death from any cause.

    Measured: Up to 1 year

Secondary outcomes (7)

  1. Overall Survival(OS)

    Overall survival (OS) is defined as the time from treatment initiation to death from any cause.

    Measured: Up to 3 years

  2. Objective Response Rate(ORR)

    Objective response rate (ORR) is defined as the percetage of participants achieving a complete response (CR) or partial response (PR) according to RECIST v.1.1.

    Measured: Up to 3 years

  3. Clinical Benefit Rate(CBR)

    Clinical Benefit Rate(CBR) is defined as the percetage of participants achieving a complete response (CR) and partial response (PR) and stable disease （SD）≥ 24 weeks according to RECIST v.1.1.

    Measured: Up to 3 years

  4. Duration of response(DOR)

    Duration of response (DOR) is defined as the duration from response initiation (when either CR or PR ) to progression or death, whichever occurs first.

    Measured: Up to 3 years

  5. Health-Related Quality of Life

    Quality of life measures will be assessed at baseline, the 28th day of the first cycle the 28th day of the fourth cycle, and the 28th day of each subsequent cycle, at the end of the treatment and will be collected using patient reported outcome questionnaires: Cancer Treatment Function Evaluation System - Breast Cancer (FACT-B)

    Measured: Up to 3 years

  6. Treatment compliance

    The proportion of high, medium and low adherence to each drug will be calculated along with the binomial exact 95% confidence interval.

    Measured: Up to 3 years

  7. Number of participants with adverse events

    Adverse events are assessed by CTCAE v5.0

    Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2025
  2. Study start5 Jan 2026 (estimated)
  3. Primary completionJan 2028 (estimated)
  4. Study completion30 Dec 2028 (estimated)

Resources

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
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07235618
Sponsor's protocol ID
EOC103D201
Status last verified
Nov 2025
First submitted
14 Nov 2025
Last updated
19 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Entinostat and Fulvestrant in people with Locally Advanced or Metastatic Breast Cancer, run by Sun Yat-sen University 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 18 inclusion and 9 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: opening soon, as of the sponsor's last update on 19 Nov 2025. 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 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?

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 Shusen Wang, MD (+86-02087342491, wangshs@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07235618.

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 Nov 2025.

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