OncoMatch/Clinical Trials/NCT07708194
Entinostat Plus Pyrotinib and Endocrine Therapy in Advanced Triple-Positive Breast Cancer After Trastuzumab Failure
Is NCT07708194 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1/2 trial studies multiple treatments including entinostat and Pyrotinib for breast cancer.
Treatment: entinostat · Pyrotinib · endocrine therapy — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression (testing required; no eligibility threshold specified)
HR+ breast cancer
Required: HER2 (ERBB2) overexpression (IHC 3+ or FISH confirmed)
HER2 positive defined as IHC 3+ or FISH confirmed
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Must have received: HER2-targeted therapy (trastuzumab)
Prior treatment with trastuzumab
Must have received: taxane
taxane-based anticancer therapy
Must have received: systemic anticancer therapy — advanced setting
Received 1-2 prior lines of systemic anticancer therapy in the advanced setting
Cannot have received: HDAC inhibitor
Prior treatment with any HDAC inhibitor for antitumor therapy
Cannot have received: HER2-targeted tyrosine kinase inhibitor (lapatinib, neratinib, pyrotinib)
Prior or current use of any HER2-targeted tyrosine kinase inhibitor (including lapatinib, neratinib, pyrotinib, etc.)
Lab requirements
Blood counts
ANC ≥ 1.5×10^9/L, platelet ≥ 100×10^9/L, hemoglobin ≥ 90 g/L
Kidney function
BUN and Cr ≤ 1.5×ULN with creatinine clearance ≥ 50 mL/min
Liver function
TBIL ≤ 1.5×ULN; ALT and AST ≤ 2.5×ULN (or ≤ 5×ULN in the presence of liver metastases)
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07708194 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior HDAC inhibitor, HER2-targeted tyrosine kinase inhibitor disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify