Trials / Active Not Recruiting
Active Not RecruitingNCT06316531
A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer
A Randomized Controlled Phase III Clinical Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 274 (actual)
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable locally advanced or metastatic HER2-positive breast cancer who had failed previous treatment with taxanes and trastuzumab.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BL-M07D1 | Administration by intravenous infusion for a cycle of 3 weeks. |
| DRUG | T-DM1 | Administration by intravenous infusion for a cycle of 3 weeks. |
Timeline
- Start date
- 2024-05-08
- Primary completion
- 2026-05-01
- Completion
- 2026-05-01
- First posted
- 2024-03-18
- Last updated
- 2025-08-19
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06316531. Inclusion in this directory is not an endorsement.