QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk ER+/HER2- Breast Cancer — QUEEN-Neo  

Neoadjuvant Therapy Clinical Trial

Official title: A Phase II Study of Neoadjuvant QL1706 Plus Chemotherapy in Participants With High-Risk ER+/HER2- Early-Stage Breast Cancer (QUEEN-Neo)

Status Not yet recruiting

Clinical Trial Summary

This study will look at the efficacy and safety of QL1706 plus albumin-bound paclitaxel followed by AC/EC in a neoadjuvant setting, in high-risk, ER+/HER2- early breast cancer.

Clinical Trial Description

This study is a single-arm, single-center, phase II clinical trial aimed at observing and evaluating the effectiveness and safety of QL1706 combined with albumin-bound paclitaxel, sequential AC (doxorubicin/cyclophosphamide) neoadjuvant therapy for early high-risk ER+/HER2- breast cancer.

A total of 76 subjects are planned to be enrolled. After enrollment, subjects will receive QL1706 combined with albumin-bound paclitaxel for 4 cycles followed by sequential AC/EC treatment for 4 cycles. Each treatment cycle will span 3 weeks until the occurrence of a specified treatment termination event, after which subjects will continue to undergo postoperative efficacy and safety assessments.

Safety assessments will be conducted before each QL1706 treatment cycle. Imaging evaluations will be performed every 2 cycles until completion of 8 cycles of treatment to assess efficacy. Additional imaging assessments may be performed as clinically indicated during the study. Tumor imaging assessments will continue until confirmed disease progression according to RECIST v1.1 criteria, initiation of new anti-tumor therapy, withdrawal of consent, or death, whichever occurs first.

Following treatment completion, a treatment completion visit will be conducted. Subjects who discontinue treatment due to reasons other than RECIST v1.1-defined disease progression will undergo regular tumor imaging assessment follow-ups to evaluate time to disease progression. Subjects will also undergo survival follow-up visits every 6 months (every 3 months in the first year and every 6 months thereafter) after treatment completion to collect and record survival status and subsequent anti-tumor treatment information. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Early Breast Cancer
• Neoadjuvant Therapy

• NCT number: NCT06404463
• Study type: Interventional
• Source: Fudan University
• Contact: Zhimin Shao, MD, PhD
• Phone: +86-021-64175590
• Email: zhimingshao@yahoo.com
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 6, 2024
• Completion date: November 6, 2030