Neoadjuvant QL1706 (Iparomlimab + Tuvonralimab) with chemotherapy for HR-positive, HER2-negative breast cancer
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
PHASE2 · RenJi Hospital · NCT07396324
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 | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 55 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | RenJi Hospital (other) |
| Drugs / interventions | Iparomlimab, Tuvonralimab |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07396324 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: HR-positive/HER2-negative Breast Cancer