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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QL1706 Combination Therapy | Experimental | neoadjuvant QL1706 plus chemotherapy (four cycles of TP ± four cycles of AC). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QL1706 combined with Chemotherapy | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| tpCR(ypT0/is ypN0) | Up to approximately 27-30 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Radiologic complete response rate (iCR) | Up to approximately 27-30 weeks | |
| epirubicin-cyclophosphamide regimen utilization rate | Up to approximately 16 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongsheng Jia, Doctor | Contact | +86 18622199359 | yongshengjia@tjmuch.com | |
| Wenxiao Liu | Contact | +86 18515456035 | liuwenxiao2016@outlook.com |
| Name | Affiliation | Role |
|---|---|---|
| Yongsheng Jia | Tianjin Medical University Cancer Institute and Hospital | Study Chair |
| Jun Zhang | Tianjin Medical University Cancer Institute and Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute & Hospital | Tianjin | China |
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|
| Event-free Survival (EFS) as assessed by Investigator |
| Up to approximately 8 years |
| Percentage of participants who experience an adverse event (AE) | Up to approximately 60 weeks |
| Overall survival (OS) | Up to approximately 8 years |
| Health-Related Quality of Life (HR-QoL) score | Up to approximately 27-30 weeks |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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