NCT07467330 Dalpiciclib Isethionate Metastatic 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 NCT07467330 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: 17 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07467330 is a hot trial to watch
Metastatic breast cancer is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07467330 is notable because it evaluates Dalpiciclib Isethionate in a Phase 3 design sponsored by Fujian Cancer Hospital. 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 | NCT07467330 |
| Official title | Dalpiciclib Combined With Endocrine Therapy and Metronomic Capecitabine vs Dalpiciclib Combined With Endocrine Therapy for First-line Treatment |
| Phase / status | Phase 3 / Recruiting |
| Intervention | Dalpiciclib Isethionate |
| Sponsor | Fujian Cancer Hospital |
| Geography | China |
| Enrollment | [object Object] |
| Primary endpoint | PFS |
| Endpoint time frame | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
This study is an open-label, multicenter, randomized controlled study. It is planned to include 258 patients with HR +/HER2- advanced breast cancer with visceral metastases. Eligible subjects will be randomized 1:1 to receive dalpiciclib in combination with endocrine therapy and metronomic capecitabine chemotherapy in the experimental arm and dalpiciclib in combination with endocrine therapy in the control arm. Randomization was stratified by the number of lines of therapy for recurrent metastases (0 versus 1) and endocrine therapy (AI versus fulvestrant).
Allocation is Randomized, masking is None (Open Label), and the intervention model is Parallel 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.
- PFS (From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months)
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: Dalpiciclib Isethionate 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: Fujian Cancer Hospital is resolved to a normalized organization record in Fuzhou, 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
NCT07467330 provides a focused lens on Metastatic breast cancer development. Its value will be determined by whether Dalpiciclib Isethionate can convert the current Phase 3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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