NCT07299890

An Exploratory Study of Pertuzumab and Trastuzumab in Combination With Palbociclib and Exemestane as Neoadjuvant Therapy for Triple-Positive Breast Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Anhui Provincial Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, multicenter, single-arm, exploratory study. A total of 90 patients with early/later-stage triple-positive breast cancer who were scheduled to receive neoadjuvant therapy were recruited. They received neoadjuvant treatment with trastuzumab, pertuzumab, palbociclib, and exemestane in combination. The aim of this study is to evaluate the efficacy and safety of the neoadjuvant treatment regimen of trastuzumab-pertuzumab combined with palbociclib and exemestane in triple-positive breast cancer.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab and Pertuzumab Combination with Palbociclib and Exemestane	Neoadjuvant treatment regimen: QL1701 (Trastuzumab for Injection): First dose 8mg/kg, then 6mg/kg, every 3 weeks, for a total of 6 cycles; QL1209 (Pertuzumab Injection): First dose 840mg, then 420mg, every 3 weeks, for a total of 6 cycles; Palbociclib: 125mg/day, days 1-21, every 4 weeks, for a total of 5 cycles; Exemestane: 25mg/day, every 4 weeks, for a total of 5 cycles.

Timeline

• Start date: 2025-12-20
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2025-12-23
• Last updated: 2025-12-23