Trials / Active Not Recruiting
Active Not RecruitingNCT06057610
A Phase III Study of SHR-A1811 Injection With or Without Pertuzumab in HER2-Positive Recurrent or Metastatic Breast Cancer
A Phase III Multicenter, Randomized, Open-label, Active-Controlled Study of SHR-A1811 With or Without Pertuzumab Versus Trastuzumab, Pertuzumab and Docetaxel in HER2-Positive Recurrent or Metastatic Breast Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 868 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHR-A1811 Injection | SHR-A1811 Injection |
| DRUG | SHR-A1811 Injection ； Pertuzumab Injection | SHR-A1811 Injection ； Pertuzumab Injection |
| DRUG | Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection | Trastuzumab Injection；Pertuzumab Injection ； Docetaxel Injection |
Timeline
- Start date
- 2023-10-16
- Primary completion
- 2027-10-01
- Completion
- 2032-10-01
- First posted
- 2023-09-28
- Last updated
- 2026-03-11
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06057610. Inclusion in this directory is not an endorsement.