NCT07518173

A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer

A Randomized Controlled Phase III Clinical Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 596 (estimated)
• Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 combined with Pertuzumab versus docetaxel plus Trastuzumab and Pertuzumab in patients with first-line HER2-positive recurrent or metastatic breast cancer.

Detailed description

In this trial, the treatment group receives BL-M07D1 and pertuzumab, while the control group receives trastuzumab, pertuzumab, and docetaxel.

Conditions

• HER2-positive Breast Cancer

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.
DRUG	Trastuzumab	Administration by intravenous infusion for a cycle of 3 weeks.
DRUG	Docetaxel	Administration by intravenous infusion for a cycle of 3 weeks.

Timeline

• Start date: 2026-04-01
• Primary completion: 2029-12-01
• Completion: 2029-12-01
• First posted: 2026-04-08
• Last updated: 2026-04-08

Locations

2 sites across 1 country: China