NCT07093931

Efficacy and Safety of Lobaplatin and Carboplatin as Neoadjuvant Therapy in HER-2 Positive Breast Cancer

A Phase Ⅲ Study to Evaluate Efficacy and Safety of Lobaplatin and Carboplatin as Neoadjuvant Therapy in Participants With HER-2 Positive Breast Cancer.

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 468 (estimated)
• Sponsor: Shandong Cancer Hospital and Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study was to evaluate the efficacy, safety and tolerability of lobaplatin versus carboplatin as neoadjuvant therapy for stage II / III HER-2 positive breast cancer. Arms and Interventions Control group : Docetaxeor albumin paclitaxel combined with carboplatin for 6 cycles. Trastuzumab combined with pertuzumab : 6 cycles of treatment, according to the instructions recommended dosage. Experimental group : Docetaxel or albumin paclitaxel combined with lobaplatin for 6 cycles. Trastuzumab combined with pertuzumab : 6 cycles of treatment, according to the instructions recommended dosage.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	lobaplatin	30mg / m2 i.v. q3w
DRUG	carboplatin	AUC 5-6 i.v. q3w
DRUG	Docetaxel or albumin paclitaxel	Docetaxel ( 75 mg / m2 i.v. d1, q3w ) or albumin paclitaxel ( 260 mg / m2 i.v. d1, q3w )
DRUG	Trastuzumab	6 cycles of treatment, according to the instructions recommended dosage.
DRUG	pertuzumab	6 cycles of treatment, according to the instructions recommended dosage.

Timeline

• Start date: 2025-08-01
• Primary completion: 2027-08-01
• Completion: 2030-08-01
• First posted: 2025-07-30
• Last updated: 2025-07-30

Locations

1 site across 1 country: China