Neoadjuvant QL1706 (Iparomlimab + Tuvonralimab) with chemotherapy for HR-positive, HER2-negative breast cancer
Official title: NEOadjuvant Iparomlimab and Tuvonralimab (QL1706) Plus Chemotherapy in Patients With Hormone Receptor Positive And HER2-Negative Breast Cancer: a Prospective, Single Arm, Multicenter Clinical Trial
Run by RenJi Hospital · NCT07396324 · Data updated 2026-11-12
This trial will test whether giving QL1706 (two immunotherapy antibodies) together with paclitaxel and carboplatin before surgery helps people with hormone receptor–positive, HER2‑negative breast cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 55 (estimated) |
| Sponsor | RenJi Hospital Academic / other |
| Drugs / interventions | Iparomlimab, Tuvonralimab |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | May 1, 2026 |
| Main results expected | December 2026 |
| Study ends | December 2031 |
| Registry record updated | May 13, 2026 |
| Trial ID | NCT07396324 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with histologically confirmed hormone receptor–positive, HER2‑negative non‑metastatic breast cancer who have at least one evaluable lesion, ECOG 0–1, and adequate organ function are the intended participants.
✕Probably not a fit
Patients with metastatic (Stage IV) disease, HER2‑positive tumors, those who cannot tolerate chemotherapy or immunotherapy, or pregnant or lactating women are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, open‑label, multicenter Phase 2 study giving neoadjuvant QL1706 (Iparomlimab plus Tuvonralimab) combined with paclitaxel and carboplatin to patients with hormone receptor–positive, HER2‑negative breast cancer. Eligible adults must have histologically confirmed disease, at least one measurable lesion, ECOG 0–1, and adequate organ function, and must not have metastatic (Stage IV) disease. Treatment is administered before planned surgery to shrink tumors and investigators will monitor tumor response, surgical outcomes, and safety. The study is being conducted at RenJi Hospital, Shanghai Jiao Tong University.
Why it matters
Potential benefit: If successful, this approach could increase tumor shrinkage before surgery and potentially improve surgical outcomes or long‑term control for this breast cancer subtype.
How similar studies have gone: Neoadjuvant immunotherapy has shown benefit primarily in triple‑negative breast cancer, while its benefit in hormone receptor–positive, HER2‑negative disease remains relatively unproven and thus this approach is relatively novel for this subtype.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where it's running
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Renji Hospital, School of Medicine, Shanghai Jiaotong University
Shanghai, China Recruiting
Study contacts
- Principal investigator: Wenjin Yin — Renji Hospital, School of Medicine, Shanghai Jiaotong University
- Study coordinator: Wenjin Yin
- Email: yinwenjin@renji.com
- Phone: 86(21)68385569
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.