OncoMatch/Clinical Trials/NCT07330544
A Phase II Clinical Study Evaluating Entinostat With or Without Anlotinib + Fulvestrant for the Treatment of Hormone Receptor (HR) -Positive, Human Epidermal Growth Factor Receptor-2 (HER-2) -Negative Advanced Breast Cancer That Relapsed or Progressed After Endocrine Therapy
Is NCT07330544 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including entinostat and Fulvestrant for breast cancer.
Treatment: entinostat · Fulvestrant · Anlotinib — * This study was an open, multicenter phase II clinical trial that enrolled 118 patients with HR+/HER2- with recurrent or progressive advanced breast cancer treated with CDK4/6 inhibitors; * The study adopted the Simon phase 2 design, and all 20 eligible patients were treated with entinostat + fulvestrant; The study was terminated if no more than 2 patients achieved objective response and continued to enter Phase 2 if no more than 3 patients achieved objective response. In Phase 2, qualified patients were randomly assigned at a ratio of 1:1.5 to either the entestasta + fluvestrus group (Group 1) or the anlotinib + entestasta + fluvestrus group (Group 2), with 39 patients enrolled in group 1 and 59 patients enrolled in group 2; All patients were treated until the subjects' treatment would continue until the subjects experienced disease progression, intolerable toxicity, active withdrawal from treatment, or other conditions specified in the protocol, whichever occurred first. * During the study period, efficacy evaluations will be conducted every 8 weeks in accordance with the Solid Tumor Efficacy Evaluation Criteria (RECIST) v1.1 until disease progression, the initiation of a new anti-tumor treatment by the subject, or the withdrawal of informed consent, whichever occurs first. * Continuous safety evaluations will be conducted during the study treatment period. All subjects who have received at least one study treatment will be required to undergo end-of-treatment visits and safety follow-up visits within 7 days and 30±2 days after the last study treatment, respectively. * The end of the study was defined as the occurrence of disease progression or the end of the study treatment in all subjects, or the early termination of the study for other reasons, whichever occurred first.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (estrogen receptor (ER) positive (≥1% positive staining cells))
Hormone receptor positive refers to estrogen receptor (ER) positive, progesterone receptor (PR) negative or positive (≥1% positive staining cells are considered receptor positive)
Required: HER2 (ERBB2) negative (IHC 0 or 1+, or IHC 2+ and ISH/FISH negative)
HER-2 negative means: the immunohistochemical result of the pathological specimen test is 0 or 1+; Or an immunohistochemical result of 2+ and a negative ISH or FISH test.
Allowed: PR (PGR) overexpression or negative
progesterone receptor (PR) negative or positive (≥1% positive staining cells are considered receptor positive)
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: endocrine therapy — unresectable locally advanced or metastatic
The subject has received at least one line of endocrine therapy as well as CDK 4/6 inhibitor therapy at an unresectable stage of locally advanced recurrence or metastasis; Or disease recurrence occurred during ET combined with CDK4/6 inhibitors as adjuvant therapy or within 12 months after the end of treatment.
Must have received: CDK4/6 inhibitor — unresectable locally advanced or metastatic
The subject has received at least one line of endocrine therapy as well as CDK 4/6 inhibitor therapy at an unresectable stage of locally advanced recurrence or metastasis; Or disease recurrence occurred during ET combined with CDK4/6 inhibitors as adjuvant therapy or within 12 months after the end of treatment.
Cannot have received: chemotherapy
Exception: for metastatic disease
The subject has not received chemotherapy or ADC therapy for metastatic disease
Cannot have received: antibody-drug conjugate
Exception: for metastatic disease
The subject has not received chemotherapy or ADC therapy for metastatic disease
Cannot have received: selective estrogen receptor degrader (fulvestrant)
Previous use of selective estrogen receptor degraders (SERD, such as fulvestrant)
Cannot have received: histone deacetylase inhibitor (entinostat, chidamide)
histone deacetylase (HDAC) inhibitors (such as entectamine, chidamide, etc.)
Cannot have received: small molecule multi-target tyrosine kinase inhibitor (anlotinib, apatinib)
small molecule multi-target tyrosine kinase inhibitors (such as apatinib, anlotinib, etc.)
Cannot have received: PI3K inhibitor (alpelisib)
PAM pathway inhibitors (such as PI3K inhibitor Alpelisib, AKT inhibitor Capivasertib, MTOR inhibitor everolimus, etc.)
Cannot have received: AKT inhibitor (capivasertib)
PAM pathway inhibitors (such as PI3K inhibitor Alpelisib, AKT inhibitor Capivasertib, MTOR inhibitor everolimus, etc.)
Cannot have received: mTOR inhibitor (everolimus)
PAM pathway inhibitors (such as PI3K inhibitor Alpelisib, AKT inhibitor Capivasertib, MTOR inhibitor everolimus, etc.)
Lab requirements
Blood counts
Hemoglobin (HgB) ≥80 g/L, platelet count ≥100×10^9 /L, absolute neutrophil count ≥1.0×10^9 /L. Platelet transfusion is not allowed within 3 days before these laboratory tests, red blood cell transfusion is not allowed within 14 days, and hematopoietic growth factor (pegylated G-CSF, 14 days for erythropoietin) is not allowed within 7 days. No blood transfusion or use of auxiliary white blood cell, platelet increase drugs such as cytokines or erythropoietin drugs within 2 weeks prior to the screening test.
Kidney function
Serum creatinine ≤1.5×ULN, or eGFR ≥60 mL/min/1.73m2. Urine protein <2+ or 24-hour urine protein quantification <1g
Liver function
Total bilirubin ≤1.5×ULN; If Gilbert syndrome is present, total bilirubin ≤3 mg/dL; ALT and AST ≤3×ULN; If there is liver metastasis, both ALT and AST should be ≤5×ULN; ALP ≤2.5×ULN; If there is bone metastasis, it should be ≤5×ULN.
Cardiac function
Echocardiography shows left ejection fraction (LVEF) ≥50% and QTc interval ≤480 ms.
The patient must have adequate organ function within 1 week (7 days) prior to the initiation of study administration, as defined below: Hematology: Hemoglobin (HgB) ≥80 g/L, platelet count ≥100×10^9 /L, absolute neutrophil count ≥1.0×10^9 /L. Renal function: Serum creatinine (Cre) ≤1.5× ULN, or glomerular filtration rate (eGFR) ≥60 mL/min/1.73m2. Urine protein <2+ or 24-hour urine protein quantification <1g. Liver function: Total bilirubin ≤1.5×ULN; If Gilbert syndrome is present, total bilirubin ≤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. Echocardiography shows left ejection fraction (LVEF) ≥50% and QTc interval ≤480 ms.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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