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Entinostat Plus Pyrotinib and Endocrine Therapy in Advanced Triple-Positive Breast Cancer After Trastuzumab Failure

NCT07708194 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2026-07-16

No results posted yet for this study

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 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.

Conditions

Interventions

DRUG

entinostat

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.

DRUG

Pyrotinib

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.

DRUG

endocrine therapy

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.

Sponsors & Collaborators

  • Taizhou EOC Pharma Co., Ltd.

    collaborator INDUSTRY

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-23
Primary Completion
2027-02-28
Completion
2027-02-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07708194 on ClinicalTrials.gov