drugset / Trial / NCT06957886
A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-low Recurrent/Metastatic Breast Cancer
Phase 3
Recruiting
566 enrolled
Sichuan Baili Pharmaceutical Co., Ltd.
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial is a registered, phase III, randomized, open-label and multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable, locally recurrent or metastatic HER2-low breast cancer.
Timeline
- Start
- 2025-05-15
- Primary completion
- 2027-05
- Completion
- 2027-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Albumin paclitaxel | Unknown | — | Intravenous |
| Subject | BL-M07D1 | Unknown | — | Intravenous |
| Comparator | Capecitabine | Small molecule | — | Oral |
| Comparator | Eribulin | Small molecule | — | Intravenous |
| Comparator | Gemcitabine | Small molecule | — | Intravenous |
| Comparator | Paclitaxel | Small molecule | — | Intravenous |