NCT07396324 Neoadjuvant QL1706 in Patients With Hormone Receptor Positive, HER2-negative Breast Cancer
| NCT ID | NCT07396324 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | RenJi Hospital |
| Condition | HR-positive/HER2-negative Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2026-05-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 55 participants in total. It began in 2026-05-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Wenjin Yin
PRINCIPAL INVESTIGATOR
Renji Hospital, School of Medicine, Shanghai Jiaotong University
Frequently Asked Questions
Who can join the NCT07396324 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying HR-positive/HER2-negative Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07396324 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07396324 currently recruiting?
Yes, NCT07396324 is actively recruiting participants. Contact the research team at yinwenjin@renji.com for enrollment information.
Where is the NCT07396324 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07396324 clinical trial?
NCT07396324 is sponsored by RenJi Hospital. The principal investigator is Wenjin Yin at Renji Hospital, School of Medicine, Shanghai Jiaotong University. The trial plans to enroll 55 participants.
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