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SHR-A1811 Injection / HER2 Positiverecurrent Or Metastatic Breast Cancer / SHR-A1811 Injection ； Pertuzumab Injection · Phase 3 Trial
ClinicalTrials.gov · September 9, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is an ongoing Phase 3 trial comparing SHR-A1811 (with or without pertuzumab) against the trastuzumab-pertuzumab-docetaxel standard in HER2-positive recurrent or metastatic breast cancer. No efficacy or safety results have been posted in this registry record, and the study remains active but not enrolling. Evidence strength cannot be determined until results are reported.
Phase 3, Interventional, Randomized, Parallel, Open label, Treatment purpose. HER2-PositiveRecurrent or Metastatic Breast Cancer; Female; age from 18 Years; to 75 Years. Intervention: Treatment group A: SHR-A1811 Injection; Treatment group B: SHR-A1811 Injection and Pertuzumab Injec…. Compared with: Treatment group C: Trastuzumab Injection, Pertuzumab Inject… — Active Comparator. n = 868. 1 site: China.
This is an ongoing Phase 3 trial comparing SHR-A1811 (with or without pertuzumab) against the trastuzumab-pertuzumab-docetaxel standard in HER2-positive recurrent or metastatic breast cancer. No efficacy or safety results have been posted in this registry record, and the study remains active but not enrolling. Evidence strength cannot be determined until results are reported.
No efficacy or safety results reported in this registry record; study is ongoing.
The source did not state who this applies to in practice.
This is an active Phase 3 trial registry record with no results posted; the study is ongoing and efficacy and safety data are not yet available for analysis.
As stated by the source record.
Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06057610). This is a study registration, not published results. Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 868 participants (ACTUAL). Conditions: HER2-PositiveRecurrent or Metastatic Breast Cancer. Interventions: DRUG: SHR-A1811 Injection; DRUG: SHR-A1811 Injection ； Pertuzumab Injection; DRUG: Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection. Primary outcome measures: Progression Free Survival by Blinded Independent Central Review , from first dose to disease progression, or death, whichever comes first, up to 3 years. Brief summary: To evaluate the efficacy and safety of SHR-A1811 with or without pertuzumab versus trastuzumab, pertuzumab and docetaxel in HER2-Positive Recurrent or Metastatic Breast Cancer
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.