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Neoadjuvant Therapy for Early Triple-Negative Breast Cancer: A Response-Guided Approach Using Iparomlimab and Tuvonralimab Injection in Combination With Chemotherapy

NCT07372079 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-28

No results posted yet for this study

Summary

Iparomlimab and Tuvonralimab Injection (QL1706) is a bifunctional combination antibody targeting both programmed cell death protein 1 (PD-1) and cytotoxic T-lymphocyte antigen 4 (CTLA-4). This is a prospective clinical study that plans to enroll screened, eligible early-stage breast-cancer patients to receive neoadjuvant QL1706 plus chemotherapy (four cycles of TP ± four cycles of AC). After the four TP cycles, imaging and core biopsy will be performed. Patients who achieve radiologic complete response will proceed directly to surgery; those who do not will receive four additional AC cycles before surgery. A key feature is the incorporation of an response-guided neoadjuvant therapy（RGN）model to identify sensitive patients who can forgo anthracyclines, thereby reducing long-term cardiotoxicity.

Conditions

  • Breast Cancer
  • Neoadjuvant Therapy
  • Immune Checkpoint Inhibitors
  • QL1706

Interventions

DRUG

QL1706 combined with Chemotherapy

Participants receive QL1706 every 3 weeks (Q3W) + Albumin-bound paclitaxel every 3 weeks (Q3W) + Cisplatin (Q3W) x 4 cycles. After the four TP cycles, imaging and core biopsy will be performed. Patients who achieve radiologic complete response will proceed directly to surgery; those who do not will receive QL1706 Q3W + epirubicin Q3W + cyclophosphamide Q3W x 4 cycles as neoadjuvant therapy before surgery.

Sponsors & Collaborators

  • Tianjin Medical University Cancer Institute and Hospital

    lead OTHER

Principal Investigators

  • Yongsheng Jia · Tianjin Medical University Cancer Institute and Hospital

  • Jun Zhang · Tianjin Medical University Cancer Institute and Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-05
Primary Completion
2028-12-30
Completion
2029-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07372079 on ClinicalTrials.gov