BridgeMD
New treatment option for Breast Cancer
Official title 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
ClinicalTrials.gov ID: NCT07330544
What this study is testing
What is entinostat?
entinostat is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Sign an informed consent form;
- Female, aged 18 or above;
- The patient's Eastern Tumor Collaboration Group (ECOG) physical status is 0-1;
- The patient's expected survival time is ≥3 months;
- Breast cancer patients diagnosed as HR-positive and HER-2 negative by tumor histopathological and molecular pathological typing (based on the most...
You likely can't join if
- Patients should not be enrolled if any of the following conditions occur:
- Symptomatic visceral metastases or other conditions, visceral crisis, or the investigator deems it inappropriate to use endocrine therapy;
- The patient has a past or present central nervous system metastases, or leptomeningeal disease, brain metastases;
- Previous use of selective estrogen receptor degraders (SERD, such as fulvestrant) or histone deacetylase (HDAC) inhibitors (such as entectamine...
- Known allergy to SERD, entinostat, or other drugs with a benzamide structure (such as typapride, remopilib, cloprapride, etc.), anlotinib;
- Pregnant or lactating women;
See the full eligibility criteria
- Sign an informed consent form;
- Female, aged 18 or above;
- The patient's Eastern Tumor Collaboration Group (ECOG) physical status is 0-1;
- The patient's expected survival time is ≥3 months;
- Breast cancer patients diagnosed as HR-positive and HER-2 negative by tumor histopathological and molecular pathological typing (based on the most recent report); 1) Hormone receptor positive refers to estrogen receptor...
- 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...
- The subject has not received chemotherapy or ADC therapy for metastatic disease
- At least one measurable target lesion was evaluated by the investigator in accordance with RECIST 1.1
- No known active brain metastases or leptomeningeal disease
- 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 ≥100×109 /L, absolute neutrophil count ≥1.0×10 /L. Note: Platelet transfusion is not allowed within 3 days before these laboratory tests, red blood cell transfusion...
- Renal function: Serum creatinine (Cre) ≤1.5× upper limit of normal (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...
- Having undergone bilateral oophorectomy in the past;
- Age ≥60 years;
- Age \<60 years old, natural menopause ≥12 months, no chemotherapy, tamoxifen, torremifen or ovarian function castration during this period, blood follicle-stimulating hormone (FSH) and estradiol (E2) levels within...
- Patients should not be enrolled if any of the following conditions occur:
- Symptomatic visceral metastases or other conditions, visceral crisis, or the investigator deems it inappropriate to use endocrine therapy;
- The patient has a past or present central nervous system metastases, or leptomeningeal disease, brain metastases;
- Previous use of selective estrogen receptor degraders (SERD, such as fulvestrant) or histone deacetylase (HDAC) inhibitors (such as entectamine, chidamide, etc.) or small molecule multi-target tyrosine kinase inhibitors...
- Known allergy to SERD, entinostat, or other drugs with a benzamide structure (such as typapride, remopilib, cloprapride, etc.), anlotinib;
- Pregnant or lactating women;
- Coexisting with other malignant tumors, unless radical treatment has been administered and there is no evidence of recurrence or metastasis;
- There is pericardial effusion requiring drainage, pleural effusion with obvious clinical symptoms or ascites;
- Other circumstances that the investigator deems unsuitable for inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Zhejiang, Hangzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhejiang, Hangzhou, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.