Trials / Recruiting
RecruitingNCT06891833
A Study of BL-M07D1 With or Without Pertuzumab Versus Taxane + Trastuzumab and Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer
A Randomized Controlled Phase II/III Clinical Study of BL-M07D1 With or Without Pertuzumab Versus Taxane + Trastuzumab and Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer
- Status
- Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This trial is a registered phase III, randomized, open and multicenter study to evaluate the efficacy and safety of BL-M07D1 with or without Pertuzumab in the neoadjuvant treatment of HER2-positive breast cancer. The study is divided into a single-arm study phase (Phase II) and a randomized controlled study phase (Phase III).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BL-M07D1 | Administration by intravenous infusion for a cycle of 3 weeks. |
| DRUG | Pertuzumab | Administration by intravenous infusion for a cycle of 3 weeks. |
Timeline
- Start date
- 2025-06-05
- Primary completion
- 2028-12-01
- Completion
- 2028-12-01
- First posted
- 2025-03-24
- Last updated
- 2025-10-02
Locations
30 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06891833. Inclusion in this directory is not an endorsement.