QL1706 for the Neoadjuvant Treatment of HR+/HER2- Breast Cancer

Phase 2

Not yet recruiting

• Conditions: Breast Cancer; HR+/HER2- Breast Cancer
• Interventions: Drug: QL1706; Drug: Nab-PE

• Registration Number: NCT06967103
• Lead Sponsor: Henan Cancer Hospital

Brief Summary

The goal of this clinical trial is to learn if QL1706 is effective in early HR+/HER2- breast cancer. It will also learn about the safety of QL1706. The main questions it aims to answer are:

Does QL1706 combined with neoadjuvant chemotherapy improve the pCR rate of early HR+/HER2- breast cancer? What adverse events do participants have when receiving QL1706? Participants will: Receive QL1706 plus chemotherapy or chemotherapy every 3 weeks for 6 cycles; All patients will receive surgery, and the primary end point is pathological complete response at the time of definitive surgery; After definitive surgery, the participants will receive adjuvant QL1706 every 3 weeks for up to 6 months from the beginning of the treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-30
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-09
• Last Update Submitted: 2025-05-09
• Study First Posted: 2025-05-13
• Last Update Posted: 2025-05-13
• Study Start: 2025-05-20
• Primary Completion: 2027-05-31
• Study Completion: 2029-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 238

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QL1706 group	QL1706	NabPE+QL1706 every 3 weeks for 6 cycles. Then participants will receive surgery and QL1706 will be given as monotherapy every 3 weeks up to 6 months from the beginning of the treatment.
QL1706 group	Nab-PE	NabPE+QL1706 every 3 weeks for 6 cycles. Then participants will receive surgery and QL1706 will be given as monotherapy every 3 weeks up to 6 months from the beginning of the treatment.

Primary Outcome Measures

Name	Time	Method
pathological complete response	up to 24 weeks	After neoadjuvant chemotherapy and surgery, the resected specimen (breast + axilla) was free of any invasive cancer (ie, ypT0/is, ypN0)
pathological complete response in PDL1 positive subgroup	up to 24 weeks	After neoadjuvant chemotherapy and surgery, the resected specimen (breast + axilla) was free of any invasive cancer (ie, ypT0/is, ypN0)

Secondary Outcome Measures

Name	Time	Method
adverse events	up to 24 weeks	Evaluate the nature, incidence and severity of chemotherapy adverse events according to CTCAE 5.0
Event-Free Survival (EFS)	5-10 years	Disease-free Survival,From the date of surgery to the first local, regional, contralateral or distant recurrence, and death from any cause
Objective Response Rate (ORR)	up to 24 weeks	ORR is defined as proportion of patients demonstrating either a partial response (PR) or a complete response (CR)