Neoadjuvant QL1706 in Patients With Hormone Receptor Positive, HER2-negative Breast Cancer

NCT07396324 | Recruiting Phase 2 DMC

• 1 other identifier: LY2025-422-A
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This is an prospective, open label, multicenter study to evaluate the efficacy and safety of neoadjuvant Iparomlimab and Tuvonralimab (QL1706) in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer.

Conditions

HR-positive/HER2-negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with pCR

  Number of patients with pathological complete response/Number of all eligible patients

  1-2 weeks after surgery

Secondary Outcomes (1)

• Proportion of patients with adverse events

  From the date of starting neoadjuvant therapy to the end of the treatment (up to approximately 1 year)

Study Arms (1)

neoadjuvant Iparomlimab and Tuvonralimab (QL1706)

EXPERIMENTAL

Iparomlimab and Tuvonralimab (QL1706) in combination with weekly paclitaxel and carboplatin as neoadjuvant therapy

Drug: Iparomlimab and Tuvonralimab; Drug: Paclitaxel; Drug: Carboplatin

Interventions

Paclitaxel DRUG

80mg/m\^2 qw

Also known as: PTX

neoadjuvant Iparomlimab and Tuvonralimab (QL1706)

Carboplatin DRUG

AUC=1.5, D1, 8, 15, every 28 days

Also known as: CBP

neoadjuvant Iparomlimab and Tuvonralimab (QL1706)

Iparomlimab and Tuvonralimab DRUG

5.0mg/kg qw, start from C1D15

Also known as: QL1706

neoadjuvant Iparomlimab and Tuvonralimab (QL1706)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥18 years
• Histologically confirmed hormone receptor positive and human epidermal growth factor receptor 2 (HER2) negative breast cancer
• Subjects with at least one evaluable lesion
• ECOG 0-1
• Adequate organ function

You may not qualify if:

• Metastatic disease (Stage IV)
• Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test;Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Renji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, 200127, China

RECRUITING

MeSH Terms

Interventions

Paclitaxel; Carboplatin

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Wenjin Yin

  Renji Hospital, School of Medicine, Shanghai Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenjin Yin

CONTACT

86(21)68385569; yinwenjin@renji.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief of Breast Surgery Department

Study Record Dates

• First Submitted: February 1, 2026
• First Posted: February 9, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2031
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: starting 6 months after publication
• Access Criteria: IPD can be accessed from the corresponding author on reasonable request

Locations

CN (1)