Actively Recruiting
Postoperative Chemotherapy Combined With QL1706 for High-risk Triple-negative Breast Cancer: A Prospective, Multicenter Phase II Clinical Study
Led by The First Affiliated Hospital with Nanjing Medical University · Updated on 2026-06-03
59
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor
Q
Qilu Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of combining postoperative chemotherapy with the drug QL1706 in patients with high-risk triple-negative breast cancer. This prospective, multicenter phase II clinical trial focuses on patients diagnosed with this aggressive breast cancer subtype, particularly those with lymph node involvement, to improve disease-free survival outcomes. Participants will receive eight cycles of chemotherapy alongside QL1706 after enrollment. The standard chemotherapy regimen used is the AC-T regimen, which includes four cycles of epirubicin plus cyclophosphamide followed by four cycles of a taxane. After completing these cycles, from cycle nine onwards, participants will receive QL1706 alone as maintenance treatment. Treatment will continue until specified discontinuation criteria are met, intolerable side effects occur, or consent is withdrawn, with a maximum of 17 QL1706 dosing cycles. During the study, safety assessments will occur every three weeks, and imaging evaluations will be performed every twelve weeks to monitor disease progression. After treatment ends, participants will undergo safety and survival follow-up, and if treatment is stopped for reasons other than disease progression or death, tumor progression will also be monitored. The primary outcome measured is the three-year disease-free survival rate, with additional tracking of distant disease-free survival within the same period.
CONDITIONS
Brief Title
A Prospective, Multicenter, Phase II Clinical Study of Postoperative Chemotherapy Combined With QL1706 for High-risk Triple-negative Breast Cancer.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 75 years
- Histologically or cytologically confirmed triple-negative breast cancer (IHC 0, 1+, or 2+/ISH-) or low ER/PR expression (1%-10%) per latest guidelines
- High-risk TNBC with lymph node positivity
- ECOG performance status of 0 or 1
- Agree to provide tumor tissue samples for biomarker testing
- Expected survival of 3 months or more
- Adequate vital organ function meeting specified blood counts and lab values
- Use of medically approved contraception during treatment and for 3 months after
- Negative pregnancy test within 7 days before first dose if of childbearing potential
- Not breastfeeding
You will not qualify if you...
- Active or history of autoimmune diseases except certain controlled conditions
- Use of immunosuppressants or systemic corticosteroids (>10 mg prednisone equivalent) within 2 weeks before enrollment
- History of severe hypersensitivity to monoclonal antibodies
- Previous anti-PD-1/PD-L1 therapy discontinuation due to toxicity
- Known or suspected interstitial lung disease or pneumonitis
- History or current CNS metastases
- Previous malignancies except certain skin or cervical conditions without disease for 3 years
- Poorly controlled hypertension or history of hypertensive crisis
- Recent significant cardiovascular events or heart failure
- Current thrombolytic or anticoagulant therapy excluding low-dose aspirin or heparin
- Pleural, ascites, or pericardial effusion requiring drainage unless clinically stable
- Recent thrombotic events or major vascular disease within 6 months
- Major surgery within 4 weeks prior to study
- Significant proteinuria
- Recent prior radiotherapy, chemotherapy, surgery, or antibody therapies within specified timeframes
- Active infection or fever within 7 days before dosing
- Immunodeficiency or active hepatitis B or C infection
- Prior immune checkpoint inhibitor treatment
- Recent live vaccination
- Other conditions affecting study participation or safety
- Pregnancy or breastfeeding
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 25 cycles (8 cycles combination therapy plus up to 17 cycles maintenance)
Participants receive 8 cycles of chemotherapy combined with QL1706, followed by QL1706 monotherapy as maintenance treatment until treatment discontinuation criteria are met, intolerable toxicity occurs, or consent is withdrawn.
Safety assessments every 3 weeks; imaging evaluations every 12 weeks (±7 days)
Duration - Up to 3 years
After treatment completion, participants undergo post-treatment safety and survival follow-up. Participants discontinuing treatment for reasons other than disease progression or death will also have tumor progression follow-up.
Regular follow-up visits as per protocol
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210000
Actively Recruiting
Research Team
X
Xiaoan Liu
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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