Ib/II Phase Study of SHR-A1811 Injection in HER2 Positive Breast Cancer

• Status: Not yet recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

To evaluate the safety, tolerability and efficacy of SHR-A1811 combined with pyrrolidone or patrozumab or SHR-1316 or albumin paclitaxel in patients with HER2 positive non resectable or metastatic breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Treatments: Paclitaxel; Pertuzumab

Criteria

Inclusion Criteria:

1. Women aged 18 to 75 (inclusive)

2. HER2 positive (IHC3+ or ISH+) confirmed by histology or cytology is not resectable or metastatic breast cancer.

3. ECoG score is 0 or 1

4. Expected survival ≥ 12 weeks

5. According to RECIST v1 1 standard at least one measurable lesion。

6. Good level of organ function

7. Patients voluntarily joined the study and signed informed consent

Exclusion Criteria:

1. Other malignant tumors in the past 5 years

2. Active central nervous system metastasis without surgery or radiotherapy

3. There is uncontrollable third space effusion

4. Receive other anti-tumor treatment within 4 weeks before the first

5. medicationImmunosuppressant or systemic hormone therapy was used within 2 weeks before the first medication

6. Any active autoimmune disease or history of autoimmune disease

7. History of immune deficiency

8. Clinically significant cardiovascular diseases

9. Clinically significant history of lung disease

10. The toxicity caused by previous anti-tumor treatment has not recovered to ≤ grade I

11. There is a tendency of hereditary or acquired bleeding and thrombosis

12. Active hepatitis and liver cirrhosis

13. There are other serious physical or mental diseases or laboratory abnormalities