NCT07616453 Culmerciclib ER-positive/HER2-negative 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 NCT07616453 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: 23 July 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07616453 is a hot trial to watch
ER-positive/HER2-negative Breast Cancer is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07616453 is notable because it evaluates Culmerciclib in a Phase 2 design sponsored by The Second Affiliated Hospital Zhejiang University. 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 | NCT07616453 |
| Official title | Efficacy and Safety of Culmerciclib Plus Aromatase Inhibitors in a Response-Adapted Neoadjuvant Strategy for Highly Proliferative ER-Positive/HER2-Negative Breast Cancer (TAYLOR-002) |
| Phase / status | Phase 2 / Recruiting |
| Intervention | Culmerciclib |
| Sponsor | The Second Affiliated Hospital Zhejiang University |
| Geography | China |
| Enrollment | [object Object] |
| Primary endpoint | Complete cell cycle arrest (CCCA) |
| Endpoint time frame | 4 weeks |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
This prospective, response-adapted phase II study evaluates the efficacy and safety of neoadjuvant culmerciclib in combination with aromatase inhibitors in patients with highly proliferative ER-positive/HER2-negative breast cancer. All patients initially receive induction treatment with culmerciclib plus endocrine therapy, followed by on-treatment assessment of biological and clinical response. Patients demonstrating an adequate response continue the same regimen, whereas those with a suboptimal response are transitioned to alternative treatment strategies prior to surgery. This adaptive approach aims to optimize treatment selection, improve therapeutic efficacy, and avoid unnecessary exposure to ineffective therapy.
Allocation is N/A, masking is None (Open Label), and the intervention model is Sequential 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.
- Complete cell cycle arrest (CCCA) (4 weeks) — Ki67≤2.7%
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: Culmerciclib is indexed as Small molecule drug, with target CDK2 x CDK4 x CDK6, mechanism CDK2 inhibitors, CDK4 inhibitors, CDK6 inhibitors, and global highest development status Approved.
Company & Deal Intelligence MCP profile: The Second Affiliated Hospital Zhejiang University did not return an exact normalized organization match in this snapshot. 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
NCT07616453 provides a focused lens on ER-positive/HER2-negative Breast Cancer development. Its value will be determined by whether Culmerciclib can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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