NCT07601178 Anlotinib Dihydrochloride Advanced Triple-Negative 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 NCT07601178 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 NCT07601178 is a hot trial to watch
Advanced Triple-Negative Breast Carcinoma is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07601178 is notable because it evaluates Anlotinib Dihydrochloride in a Phase 2 design sponsored by Jiangsu 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 | NCT07601178 |
| Official title | QUEEN-APPLE: A Single-Arm, Multicenter, Prospective Phase II Clinical Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Anlotinib Hydrochloride and Nab-Paclitaxel as First-Line Treatment for Advanced Triple-Negative Breast Cancer |
| Phase / status | Phase 2 / Recruiting |
| Intervention | Anlotinib Dihydrochloride |
| Sponsor | Jiangsu 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 36 months |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
This study is a single-arm, multicenter, prospective phase II clinical trial designed to evaluate the efficacy and safety of QL1706 in combination with anlotinib hydrochloride and nab-paclitaxel as first-line treatment for advanced triple-negative breast cancer. A total of 34 participants with first-line advanced triple-negative breast cancer are enrolled in this study: Enrolled participants receive QL1706 (5 mg/kg, Q3W, day 1) + anlotinib (12 mg per dose, QD, days 1-14, Q3W) + nab-paclitaxel (125 mg/m², days 1 and 8, Q3W), with a 21-day cycle. Treatment continues until disease progression, intolerable toxicity, the investigator's judgment that the participant no longer derives benefit, withdrawal of informed consent by the participant, completion of 2 years of QL1706 treatment, or other reasons specified in the protocol. The study consists of a screening period (from the signing of informed consent to no more than 28 days before the fi
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.
- 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 36 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: Anlotinib Dihydrochloride 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: Jiangsu Cancer Hospital 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
NCT07601178 provides a focused lens on Advanced Triple-Negative Breast Carcinoma development. Its value will be determined by whether Anlotinib Dihydrochloride can convert the current Phase 2 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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