Evaluating SHR-A1811 for Breast Cancer Treatment
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
This study is testing a new treatment called SHR-A1811, combined with other medications, to see if it helps women with breast cancer feel better and manage their disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 402 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. Industry-sponsored |
| Drugs / interventions | pertuzumab, adebrelimab, pyrotinib |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT05353361 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety, tolerability, and efficacy of SHR-A1811 when used in combination with other treatments such as pyrotinib, pertuzumab, adebrelimab, or albumin-bound paclitaxel in patients diagnosed with breast cancer. It involves women aged 18 to 75 who have measurable lesions and adequate organ function. Participants will be monitored for their response to the treatment and any adverse effects experienced during the trial.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 to 75 with confirmed breast cancer and a good performance status.
Not a fit: Patients with active central nervous system metastasis or those who have had recent anti-tumor treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with breast cancer.
How similar studies have performed: While this approach is being evaluated, similar studies have shown promise in combining targeted therapies for breast cancer treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nanjing, Jiangsu
- Jiangsu Provincial People's Hospital — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Xiaoxue Pi
- Email: Xiaoxue.pi@hengrui.com
- Phone: 0518-82342973
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.