NCT07498478 Fulvestrant Human epidermal growth factor 2 negative carcinoma of breast Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook

Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07498478 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: 26 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.

Why NCT07498478 is a hot trial to watch

Human epidermal growth factor 2 negative carcinoma of breast is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07498478 is notable because it evaluates Fulvestrant in a Phase 2 design sponsored by TransThera Sciences (Nanjing), Inc.. 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

The goal of this clinical trial is to learn if tinengotinib combined with fulvestrant works to treat patients with HR-Positive and HER-2-Negative or low-expressing advanced breast cancer. It will also learn about the safety of combination therapy. The main questions it aims to answer are: 1. Does tinengotinib combined with fulvestrant reduce the tumor burden in participants? 2. What medical problems do participants have when taking the combination therapy? Participants will: Take tinengotinib and fulvestrant to find the optimal dose of tinengotinib for the combination therapy in Part A. In Part B, will take tinengotinib at the optimal dose with fulvestrant or tinengotinib alone to see if the combination therapy works better than tinengotinib monotherapy.

Allocation is Randomized, masking is None (Open Label), and the intervention model is Parallel Assignment. Planned enrollment was not reported; study geography in 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.

• Part A: safety evaluation parameters(From signing of the informed consent until 28 days after the last dose or the end of the study (whichever occurs first), an average of 1 year.) — Including incidence, duration, and severity of DLTs and treatment-related adverse events (TRAEs)
• Part B: Objective Response Rate (ORR) (RECIST v1.1)(From first study drug administration to the end of treatment, an average of 1 year.) — The proportion of subjects who achieved a complete response (CR) or a partial response (PR) based on RECIST version 1.1.

Readout outlook and evidence gap

The current protocol points to not reported 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: Fulvestrant is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.

Company & Deal Intelligence MCP profile: TransThera Sciences (Nanjing), Inc. is resolved to a normalized organization record in Nanjing, 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

NCT07498478 provides a focused lens on Human epidermal growth factor 2 negative carcinoma of breast development. Its value will be determined by whether Fulvestrant can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.

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