Trastuzumab Rezetecan in Triple Negative Breast Cancer: NCT05749588 Clinical Landscape Report 2026
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This Clinical Landscape Report was built with PatSnap Life Sciences MCP workflows. Clinical Trials MCP supplies protocol and result records, Drug & Asset MCP adds asset context, and Company & Deal Intelligence MCP resolves sponsor background. Use the same structured MCP building blocks in your research workflow.
Data snapshot: 16 October 2026. This strategic research report is not medical, regulatory or investment advice. Trial status and dates can change.
Phase 2
Clinical phase
Recruiting
Recruitment status
not reported
Planned enrollment
2027-12-31
Primary-completion proxy
Executive view
NCT05749588 evaluates Trastuzumab Rezetecan in Triple Negative Breast Cancer. The disclosed sponsor is Fudan University, the design is Interventional, and the geographic footprint is China. The first listed primary endpoint is Overall response rate (ORR), assessed over Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the completion of study (approximately 3 years).
The key landscape question is whether this protocol can generate a clinically interpretable signal relative to nearby programs. Phase alone is not a measure of evidence quality. Endpoint relevance, comparator choice, masking, enrollment feasibility, patient selection, country coverage and follow-up must be considered together.
PatSnap MCP Servers make this assessment reproducible by keeping protocol facts, result evidence, asset attributes and sponsor identity in separate structured calls.
How the MCP evidence stack was assembled
Clinical Trials MCP clinical_trial_fetch retrieved the design, outcomes, phase, status, enrollment, sponsor, countries and timing for NCT05749588 and selected peers. clinical_trial_result_fetch supplied detailed result records from the wider Triple Negative Breast Cancer landscape. Drug & Asset MCP drug_fetch was queried for Trastuzumab Rezetecan, while Company & Deal Intelligence MCP organization_fetch was queried for Fudan University.
This separation reduces a common diligence error: treating a registry label, a company description or a result excerpt as if each represented the complete evidence package. Explore the source workflow at the PatSnap MCP marketplace.
Trial landscape table
| Trial | Asset / intervention | Phase / status | Sponsor | Geography | Primary endpoint | Readout proxy |
|---|---|---|---|---|---|---|
| NCT05749588 | Trastuzumab Rezetecan | Phase 2 / Recruiting | Fudan University | China | Overall response rate (ORR) Randomization until the first occurrence of disease progression or de… | 2027-12-31 |
| NCT06264921 | NKT-3447 | Phase 1 / Terminated | NiKang Therapeutics, Inc. | United States | Number of Participants with Dose Limiting Toxicity (DLT) events 28 days | 2025-04-07 |
| NCT06268327 | Gemcitabine Hydrochloride | Phase 2/3 / Not yet recruiting | Assiut University | Geography not reported | Adding adjuvant cisplatin and gemcitabine versus capecitabine in triple-negative Breast cancer patients with non pathol… 2 years | 2025-10-30 |
| NCT06257758 | VIO-01 | Phase 1/2 / Terminated | Valerio Therapeutics SA | United States | Phase 1: Dose Limiting Toxicities Baseline to 12 months | 2025-01-01 |
| NCT06257264 | Fulvestrant | Phase 1 / Terminated | BeOne Medicines Ltd. | New Zealand, United States, China, Moldova, Israel, Australia | Part 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) From the first dose of study drug(s) to 30 days after the last dose… | 2026-08-31 |
The table aligns endpoints, sponsors, phases, geographies and readout proxies. It is descriptive, not a head-to-head efficacy comparison. Differences in population, baseline risk, intervention schedule and follow-up can dominate apparent cross-trial differences.
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Protocol design and endpoint interpretation
NCT05749588 is a Phase 2, recruiting study with not reported planned participants. Allocation is Non-Randomized, masking is None (Open Label), and the intervention model is Parallel Assignment.
The primary endpoint is “Overall response rate (ORR)” over “Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the completion of study (approximately 3 years).” The retrieved endpoint description is: The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1).
Interpretation should test whether the endpoint captures a clinically meaningful change, whether its time horizon matches the proposed biology, and whether treatment discontinuation or missing data can bias the estimate. The planned enrollment of not reported should be assessed against expected effect size, event frequency, multiplicity, subgroup plans and attrition.
No named control drug was returned in the protocol field set. A placebo comparator can strengthen internal efficacy assessment, while an active comparator may better test clinical differentiation. Single-arm and open-label programs require greater weight on objective outcomes, independent assessment and external benchmarks.
Indexed readouts in the surrounding landscape
0 recent result records were selected as contextual evidence for Triple Negative Breast Cancer. These records do not establish direct evidence for NCT05749588 unless the registration number matches.
Indexed evidence status
No directly comparable result record was retrieved for this disease query. This is a monitoring gap, not evidence of absence.
Result fields should be reconciled with the source record before quantitative comparison. Population definitions, analysis sets, dose cohorts, estimands, confidence intervals, rescue therapy and follow-up can materially change the meaning of a numerical endpoint. Clinical Trials MCP supports repeatable refreshes as result records change.
Asset and sponsor context
Trastuzumab Rezetecan is indexed as Antibody drug conjugate (ADC) with HER2 x Top I biology and a global stage of Approved. The asset profile lists Jiangsu Hengrui Pharmaceuticals Co., Ltd. as an originator or developer.
Fudan University is indexed in an unreported country with the website http://www.fudan.edu.cn. Fudan University is an institution of higher education in China. The record lists 346 development-stage drug assets.
For execution diligence, monitor sponsor ownership, collaborator additions, site expansion, protocol amendments and enrollment revisions. A change in ownership or geography can alter operational confidence as well as the commercial meaning of a future readout.
Development white space
- Endpoint white space. Determine whether a more patient-relevant outcome, longer durability window or blinded central assessment would resolve uncertainty left by the current endpoint.
- Population white space. Test biomarker-defined, treatment-line or risk-stratified subgroups where effect size and unmet need could be clearer.
- Comparator white space. Identify whether the study can support differentiation against the current standard of care rather than only activity against baseline or placebo.
- Geographic white space. Assess whether the disclosed footprint supports recruitment, regulatory transferability and commercial generalizability.
- Sequencing white space. Clarify whether Trastuzumab Rezetecan is intended for monotherapy, combination, maintenance, rescue or an earlier treatment line.
White space should be framed as an unanswered development question, not merely an unoccupied mechanism label. A credible program closes a measurable clinical uncertainty with a design that can be executed and interpreted.
Strategic implications and next readouts
For sponsors, the endpoint hierarchy, safety window, enrollment pace and protocol amendment history should all support the same target product profile. Advancement criteria should be set before the readout and tied to clinical effect, uncertainty, tolerability and operational feasibility.
For business-development teams, differentiation may come from a sharper population, stronger comparator, more durable benefit, simpler delivery or clearer sequencing role. For investors, the central risk is evidence quality relative to time and capital, not the phase label in isolation.
Track recruitment status, enrollment changes, primary-completion timing, endpoint revisions, new result records, sponsor ownership and collaborator changes. Re-run the PatSnap MCP workflow when a surrogate becomes a clinical outcome, a single-country study expands, the comparator changes or a new result materially shifts the competitive benchmark.
Source trail and bottom line
Anchor trial: NCT05749588
Protocol source: https://clinicaltrials.gov/study/NCT05749588
MCP sources: Clinical Trials MCP (clinical_trial_fetch and clinical_trial_result_fetch); Drug & Asset MCP (drug_fetch); Company & Deal Intelligence MCP (organization_fetch).
Data snapshot: 16 October 2026.
Trastuzumab Rezetecan in Triple Negative Breast Cancer is best understood through the interaction of protocol design, surrounding readouts, asset context and sponsor execution. The current record makes Overall response rate (ORR) and 2027-12-31 the leading decision points.
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