NCT07246317

Evaluation of Neoadjuvant Therapy With Trastuzumab, Pertuzumab, Docetaxel, and QL1706 in Early or Locally Advanced HER2+ Breast Cancer

A Multicenter, Prospective, Randomized Phase II Trial Evaluating Trastuzumab, Pertuzumab, Docetaxel Combined With QL1706 Versus Combined With Carboplatin as Neoadjuvant Therapy for Early or Locally Advanced HER2+ Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 188 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, prospective, randomized phase II trial designed to observe and evaluate the efficacy and safety of trastuzumab, pertuzumab, docetaxel combined with QL1706 versus combined with carboplatin as neoadjuvant therapy in patients with operable or locally advanced HER2-positive breast cancer.

Detailed description

This multicenter, randomized phase II trial evaluates the efficacy and safety of neoadjuvant therapy with trastuzumab, pertuzumab, and docetaxel plus QL1706 versus the same regimen plus carboplatin in patients with operable or locally advanced HER2-positive breast cancer. The study will enroll 188 subjects, randomly assigned 1:1 to either the QL1706 combination arm or the carboplatin combination arm, stratified by nodal status and hormone receptor status (\<10% vs ≥10%). Both treatment groups will receive four 3-week cycles of assigned therapy followed by surgical resection and response assessment. Postoperative adjuvant treatment will be administered according to investigator discretion and guideline recommendations.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	QL1706 injection	On Day 1 of each cycle at a dose of 5 mg/kg, IV infusion
DRUG	Trastuzumab (or biosimilar)	On Day 1 of each cycle; 8 mg/kg IV loading dose followed by 6 mg/kg IV every 3 weeks
DRUG	Pertuzumab (or biosimilar)	On Day 1 of each cycle; 840 mg IV loading dose followed by 420 mg IV every 3 weeks
DRUG	Docetaxel	On Day 1 of each cycle at a dose of 75 mg/m², IV infusion
DRUG	Carboplatin	On Day 1 of each cycle at a dose of AUC = 4, IV infusion

Timeline

• Start date: 2025-12-15
• Primary completion: 2027-12-31
• Completion: 2032-12-31
• First posted: 2025-11-24
• Last updated: 2025-11-28

Locations

8 sites across 1 country: China