NCT07708194 Pyrotinib Maleate Hormone receptor positive breast cancer Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook

Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07708194 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.

MCP evidence snapshot: 3 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.

Why NCT07708194 is a hot trial to watch

Hormone receptor positive breast cancer is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07708194 is notable because it evaluates Pyrotinib Maleate in a Phase 1/2 design sponsored by Tianjin Medical University Cancer Institute and Hospital. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.

Trial landscape snapshot

Protocol design and endpoint interpretation

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.

Allocation is N/A, masking is None (Open Label), and the intervention model is Single Group Assignment. Planned enrollment of [object Object] participants across China shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.

• Dose-Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD), and Recommended Phase II Dose (RP2D) of Entinostat in Combination with Pyrotinib and Endocrine Therapy (Cycle 1 (Day 1 to Day 28)) — DLT is assessed during the first 28-day cycle. MTD and RP2D are determined based on the 3+3 dose-escalation design.
• Progression-Free Survival (PFS) (From first dose to disease progression or death, assessed up to 36 months) — PFS is defined as the time from the first dose of study treatment to the first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first.
• Incidence and Severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) (From signing of informed consent through 28 days after the last dose of study treatment) — AEs and SAEs are graded according to NCI CTCAE v5.0, including hematological and non-hematological toxicities.

Readout outlook and evidence gap

The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.

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Asset and sponsor context

Drug & Asset MCP profile: Pyrotinib Maleate is indexed as Small molecule drug, with target EGFR x HER2 x HER4, mechanism EGFR antagonists, HER2 antagonists, HER4 antagonists, and global highest development status Approved.

Company & Deal Intelligence MCP profile: Tianjin Medical University Cancer Institute and Hospital is resolved to a normalized organization record in Tianjin Shi, China. The organization workflow adds identity, location, portfolio and partnering context where available.

The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.

White space around this program

• Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
• Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
• Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
• Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
• Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.

What to monitor next

Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.

Bottom line

NCT07708194 provides a focused lens on Hormone receptor positive breast cancer development. Its value will be determined by whether Pyrotinib Maleate can convert the current Phase 1/2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.

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