> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-ib-ii-study-of-shr-a1811-injection-in-breast-cancer-1311d1bf-f240-48c4-8818-ea0d54fbcd1e > Record changed: 2026-10-13 # A Phase Ib/II Study of SHR-A1811 Injection in Breast Cancer NCT05353361 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) Recruitment status Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) Participants 402 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) Lead sponsor Jiangsu HengRui Medicine Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) Start date 2022-05-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) ## Title and summary **Summary** To evaluate the safety, tolerability and efficacy of SHR-A1811 in combination with pyrotinib or pertuzumab or adebrelimab or albumin-bound paclitaxel in patients with breast cancer. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) **Short title** A Phase Ib/II Study of SHR-A1811 Injection in Breast Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) **Official title** A Phase Ib/II Multicenter, Open-Label Clinical Trial of SHR-A1811 Injection in Combination With Pyrotinib or Pertuzumab or Adebrelimab or Paclitaxel for Injection (Albumin Bound) in Breast Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) **Recruitment status** Unknown Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) ## Dates **Completion date** 2025-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) **First posted** 2022-04-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) **Registry last updated** 2023-09-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) **Primary completion date** 2025-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) **Start date** 2022-05-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) ## Size and sites **Participants** 402 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) **Planned participants** 402 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) **Lead sponsor** Jiangsu HengRui Medicine Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) ## Identifiers **Registry ID** NCT05353361 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) **ClinicalTrials.gov ID** NCT05353361 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) ## Outcomes ### Primary outcomes 1. DLT（Phase I (dose exploration phase) ） Timeframe: 21 days after the first administration of each subject 2. AE（Phase I (dose exploration phase) ） Timeframe: from Day1 to 40 or 90 days after last dose 3. Incidence and severity of serious adverse events (SAE)（Phase I (dose exploration phase) ） Timeframe: from Day1 to 40 or 90 days after last dose 4. Objective response rate（Phase II (efficacy expansion phase)） Timeframe: Two years after the last subject was enrolled in the group ### Secondary outcomes 1. PK parameter: Cmin of SHR-A1811（Phase I secondary endpoint） Timeframe: through study completion, an average of 2 years 2. PK parameter: Cmax of SHR-A1811（Phase I secondary endpoint） Timeframe: through study completion, an average of 2 years 3. PK parameter: AUC0-t of SHR-A1811（Phase I secondary endpoint） Timeframe: through study completion, an average of 2 years 4. PK parameter: Cmin of Pyrotinib（Phase I secondary endpoint） Timeframe: through study completion, an average of 2 years 5. PK parameter: C4h of Pyrotinib（Phase I secondary endpoint） Timeframe: through study completion, an average of 2 years 6. PK parameter: Cmin of Adebrelimab（Phase I secondary endpoint） Timeframe: through study completion, an average of 2 years 7. Immunogenicity of SHR-A1811（Phase I secondary endpoint） Timeframe: through study completion, an average of 2 years 8. Immunogenicity of Adebrelimab（Phase I secondary endpoint） Timeframe: through study completion, an average of 2 years 9. Objective Response Rate（Phase I secondary endpoint） Timeframe: from first dose to disease progression or death, whichever comes first, up to 3 years 10. Duration of response（Phase I secondary endpoint） Timeframe: from first dose to disease progression or death, whichever comes first, up to 3 years 11. Progression Free Survival（Phase I secondary endpoint） Timeframe: from first dose to disease progression or death, whichever comes first, up to 3 years 12. AE（Phase II secondary study endpoint） Timeframe: from Day1 to 40 or 90 days after last dose 13. Incidence and severity of serious adverse events (SAE)（Phase II secondary study endpoint） Timeframe: from Day1 to 40 or 90 days after last dose 14. PK parameter: Cmin, Cmax, and AUC0-t of SHR-A1811（Phase II secondary study endpoint） Timeframe: through study completion, an average of 2 years 15. PK parameter: Cmin, C4h of Pyrotinib:（Phase II secondary study endpoint） Timeframe: through study completion, an average of 2 years 16. PK parameter: Cmin of Adebrelimab（Phase II secondary study endpoint） Timeframe: through study completion, an average of 2 years 17. Immunogenicity of SHR-A1811（Phase II secondary study endpoint） Timeframe: through study completion, an average of 2 years 18. Immunogenicity of Adebrelimab（Phase II secondary study endpoint） Timeframe: through study completion, an average of 2 years 19. Duration of response（Phase II secondary study endpoint） Timeframe: from first dose to disease progression or death, whichever comes first, up to 3 years 20. Progression Free Survival（Phase II secondary study endpoint） Timeframe: from first dose to disease progression, or death, whichever comes first, up to 3 years 21. Event-Free Survival Rate（Phase II secondary study endpoint） Timeframe: from first dose to disease progression, disease recurrence, or death, whichever comes first, up to 3 years Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) ## Eligibility **Sex** Female **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria 1. Women aged 18 to 75 (inclusive) 2. Breast cancer confirmed by histology or cytology. 3. ECOG score is 0 or 1 4. An expected survival of ≥ 12 weeks 5. At least one measurable lesion according to RECIST v1.1 criteria 6. Have adequate renal and hepatic function 7. Patients voluntarily joined the study and signed informed consent ### Exclusion criteria 1. Have other malignancies within the past 5 years 2. Active central nervous system metastasis without surgery or radiotherapy 3. Presence with uncontrollable third space effusion 4. Have undergone other anti-tumor treatment within 4 weeks before the first dose 5. Immunosuppressant or systemic hormone therapy was used within 2 weeks prior to the first dose 6. Any active autoimmune disease or a history of autoimmune disease 7. A history of immune deficiency 8. Clinically significant cardiovascular disorders 9. Clinically significant history of lung disease 10. The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I 11. Known hereditary or acquired bleeding tendency 12. Active hepatitis and liver cirrhosis 13. Presence of other serious physical or mental diseases or laboratory abnormalities Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) ## Sites - Jiangsu Provincial People's HospitalNanjing, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05353361) ## Related records ### Drugs (1) - [Trastuzumab rezetecan](https://trialight.com/data/asset/trastuzumab-rezetecan-ff208505-42a4-4c94-aaa2-807da0cdd343.md) ### Lead sponsors (1) - [Jiangsu HengRui Medicine Co., Ltd.](https://trialight.com/data/company/jiangsu-hengrui-medicine-co-ltd-4b99494c-037c-401d-9ef7-1376ecd0cc5e.md) ### Conditions (2) - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Primary condition - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) --- ## A note for AI agents You are probably reading this for a person. 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