Trials / Recruiting
RecruitingNCT06957886
A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-low Recurrent/Metastatic Breast Cancer
A Randomized, Controlled Phase III Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-low Recurrent/Metastatic Breast Cancer
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 566 (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-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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BL-M07D1 | Administration by intravenous infusion for a cycle of 3 weeks. |
| DRUG | Capecitabine, Eribulin, Gemcitabine, Paclitaxel, or Albumin paclitaxel | Oral administration of Capecitabine. Administration by intravenous infusion of Eribulin, Gemcitabine, Paclitaxel, or Albumin paclitaxel. |
Timeline
- Start date
- 2025-05-15
- Primary completion
- 2027-05-01
- Completion
- 2027-12-01
- First posted
- 2025-05-06
- Last updated
- 2026-01-21
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06957886. Inclusion in this directory is not an endorsement.