NCT07393321 Fulvestrant Locally Advanced Unresectable Breast Carcinoma Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook
Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07393321 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: 24 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07393321 is a hot trial to watch
Locally Advanced Unresectable Breast Carcinoma is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07393321 is notable because it evaluates Fulvestrant in a Phase 3 design sponsored by Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.
Trial landscape snapshot
| Field | Indexed detail |
|---|---|
| Registration | NCT07393321 |
| Official title | A Phase III Clinical Trial of NTQ1062 in Combination With Fulvestrant for the Treatment of Advanced or Metastatic HR+/HER2- Breast Cancer |
| Phase / status | Phase 3 / Not yet recruiting |
| Intervention | Fulvestrant |
| Sponsor | Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. |
| Geography | Not reported in the indexed record |
| Enrollment | [object Object] |
| Primary endpoint | Progression-free survival (PFS) as assessed by investigators according to RECIST v1.1 |
| Endpoint time frame | From date of inclusion until the date of first documented progression, assessed up to 60 months. Assessed every 8 weeks for the first 12 months and every 12 weeks thereafter. |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
NTQ1062-301 is a randomized, double-blind, placebo-controlled Phase III clinical trial to evaluate the efficacy and safety of the small-molecule AKT inhibitor NTQ1062 combined with fulvestrant versus placebo combined with fulvestrant in patients with HR positive, HER2 negative, locally advanced (unresectable) or metastatic breast cancer that has recurred or progressed during or after endocrine therapy and harbors PIK3CA/AKT1/PTEN alterations.
Allocation is Randomized, masking is Quadruple, and the intervention model is Parallel Assignment. Planned enrollment of [object Object] participants across Not reported in the indexed record 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.
- Progression-free survival (PFS) as assessed by investigators according to RECIST v1.1 (From date of inclusion until the date of first documented progression, assessed up to 60 months. Assessed every 8 weeks for the first 12 months and every 12 weeks thereafter.) — Progression-free survival (PFS) as assessed by investigators according to RECIST v1.1, defined as the time from randomization to the date of disease progression or death from any cause.
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: 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: Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd. 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
NCT07393321 provides a focused lens on Locally Advanced Unresectable Breast Carcinoma development. Its value will be determined by whether Fulvestrant can convert the current Phase 3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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