Actively Recruiting
A Prospective, Single-Center, Exploratory Study of QL1706 Combined With Short-Cycle Anthracyclines or Taxanes for Early-Stage Triple-Negative Breast Cancer
Led by Xijing Hospital · Updated on 2025-11-24
30
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
Sponsors
X
Xijing Hospital
Lead Sponsor
Q
Qilu Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Triple-negative breast cancer (TNBC) is a fast-growing and often recurring form of breast cancer that lacks specific receptors for targeted treatment, making chemotherapy the standard approach. This study explores the use of a new immune therapy drug called QL1706, which combines two antibodies to help the immune system fight cancer. Researchers aim to understand if combining QL1706 with different chemotherapy drugs can improve treatment for early-stage TNBC patients and whether chemotherapy doses can be safely reduced. The trial randomizes 30 patients with early-stage TNBC into two groups. One group receives QL1706 plus nab-paclitaxel and carboplatin, while the other receives QL1706 combined with pirarubicin and cyclophosphamide. Each patient undergoes four treatment cycles. If a complete response is achieved, no further chemotherapy is given. If not, additional cycles of both chemotherapy combinations with QL1706 are administered. This approach tests the effectiveness of short-cycle anthracycline or taxane chemotherapy combined with QL1706. Participants will be closely monitored from the first dose until surgery, approximately 12 to 16 weeks later. Researchers will track tumor response rates, treatment safety, and patient health through exams, lab tests, and imaging. The study also requires patients to meet specific health and performance criteria and includes follow-up to assess treatment outcomes. The goal is to find a more effective and potentially less intense treatment option for TNBC patients.
CONDITIONS
Brief Title
A Study of QL1706 Combined With Short-Cycle Anthracyclines or Taxanes for the Treatment of Early-Stage TNBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 70 years with newly diagnosed invasive breast cancer
- Diagnosed with triple-negative breast cancer (TNBC) at clinical stage cT2 to cT4 and cN0 to cN3
- Unilateral breast cancer disease
- No prior chemotherapy or immunotherapy for invasive breast cancer
- ECOG performance status of 0 to 1
- Adequate kidney, liver, heart, and bone marrow function
- Voluntary participation with signed informed consent
- Measurable tumor lesion according to RECIST 1.1 criteria
- Estimated life expectancy of at least 6 months
- Female participants must be surgically sterilized, postmenopausal, or agree to use effective contraception during treatment and for 6 months after
- Negative pregnancy test within 7 days before enrollment and not breastfeeding
- Able and willing to comply with study and follow-up procedures and visit schedules
You will not qualify if you...
- History of invasive malignant tumor within 5 years before consent, except treated basal cell or squamous skin cancer or cervical carcinoma in situ
- History of autoimmune disease
- Active hepatitis B or C infection, except controlled HBV carriers with low viral load
- Any active infection requiring systemic treatment
- Current use of corticosteroids or immunosuppressive drugs
- Previous treatment with immune checkpoint inhibitors
- Psychiatric disorders or other conditions affecting compliance
- History of allogeneic organ or stem cell transplantation
- Pregnant or breastfeeding women
- Known allergy to study drugs or their components
- Any condition making participation unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 12 to 16 weeks
Participants receive QL1706 combined with short-cycle anthracyclines or taxanes to treat early-stage triple-negative breast cancer.
Weekly visits during treatment cycles
Trial Site Locations
Total: 1 location
1
Xijing hospital
Xi'an, Shaanxi, China, 710032
Actively Recruiting
Research Team
Z
Zhe Dr. Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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