NCT07723469 SRG-514 Triple 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 NCT07723469 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: 3 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.
Why NCT07723469 is a hot trial to watch
Triple Negative Breast Cancer is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07723469 is notable because it evaluates SRG-514 in a Phase 3 design sponsored by Surge Therapeutics Inc. 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 | NCT07723469 |
| Official title | Phase 3 Trial of SRG-514 Administered Intraoperatively to Patients Undergoing Breast-Conserving Surgery |
| Phase / status | Phase 3 / Not yet recruiting |
| Intervention | SRG-514 |
| Sponsor | Surge Therapeutics Inc |
| Geography | United States |
| Enrollment | [object Object] |
| Primary endpoint | EFS by BICR assessment |
| Endpoint time frame | EFS is defined as the time from randomization to the first occurrence of an event up to 5 years post BCS. |
| Primary completion / readout proxy | [object Object] |
Protocol design and endpoint interpretation
This is a Phase 3 trial to compare SRG-514 (active pharmaceutical ingredient [API]: ketorolac) administered intraoperatively to the tumor resection cavity with standard-of-care (SOC) versus SOC alone in participants with clinical stage II-III triple negative breast cancer (TNBC) undergoing breast-conserving surgery (BCS) who are neoadjuvant therapy naïve.
Allocation is Randomized, masking is Single, and the intervention model is Parallel Assignment. Planned enrollment of [object Object] participants across United States 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.
- EFS by BICR assessment (EFS is defined as the time from randomization to the first occurrence of an event up to 5 years post BCS.) — To compare the efficacy of SOC plus SRG-514 administered intraoperatively to the tumor resection site versus SOC alone in participants undergoing BCS
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: SRG-514 is indexed as Small molecule drug, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status Phase 3.
Company & Deal Intelligence MCP profile: Surge Therapeutics Inc is resolved to a normalized organization record in MIDDLESEX COUNTY, United States. 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
NCT07723469 provides a focused lens on Triple Negative Breast Cancer development. Its value will be determined by whether SRG-514 can convert the current Phase 3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.
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