Actively Recruiting
QL1706 Plus Nab-paclitaxel with or without Bevacizumab as First-Line Treatment in Recurrent or Metastatic Triple-Negative Breast Cancer: A Non-Randomized, Multicenter Phase II Study
Led by Fudan University · Updated on 2025-02-06
60
Participants Needed
1
Research Sites
169 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of the drug QL1706 combined with albumin-bound paclitaxel, with or without bevacizumab, as a first-line treatment for women with recurrent or metastatic triple-negative breast cancer (r/mTNBC). This non-randomized, phase II study is designed to understand how these treatments work together in this specific breast cancer type, which lacks certain hormone receptors and HER2 expression. Participants will receive QL1706, a bispecific antibody targeting PD-1 and CTLA-4, along with albumin-bound paclitaxel (nab-paclitaxel). Some will also receive bevacizumab. The study involves two treatment groups: one receiving QL1706 plus nab-paclitaxel, and the other receiving QL1706 plus nab-paclitaxel with bevacizumab. Treatments are given as part of an ongoing regimen, with assessments every six weeks up to one year. During the study, participants will be closely monitored with evaluations of tumor response using RECIST 1.1 criteria at baseline and every six weeks for up to one year. Researchers will also assess safety by tracking adverse events from the start of treatment until three months after the last dose. Additional follow-up will measure progression-free survival up to two years and overall survival up to three years. Participants will undergo laboratory tests, tumor tissue biomarker analysis, and clinical assessments, with study participation lasting up to three years including follow-up.
CONDITIONS
Brief Title
QL1706 Plus Chemotherapy +/- Bevacizumab in 1L Treatment of R/mTNBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 70 years
- Diagnosed with breast cancer confirmed as estrogen receptor negative, progesterone receptor negative, and HER2 negative according to the latest ASCO/CAP guidelines
- Patients with locally advanced, recurrent, or metastatic breast cancer who have not received any systemic treatment for the advanced disease
- At least one measurable lesion as defined by RECIST 1.1 criteria
- ECOG performance status score of 0 to 1
- Available tumor tissue specimens for biomarker detection
- Adequate organ function with specified blood counts and biochemical parameters
- No use of blood components or cell growth factor drugs within 14 days before first medication
- Voluntary informed consent to participate in the study
You will not qualify if you...
- Active autoimmune disease or history of autoimmune diseases such as autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, or hyperthyroidism
- Current use of immunosuppressants or systemic steroid therapy exceeding 10 mg daily prednisone equivalent within 2 weeks before enrollment
- Severe allergic reactions to monoclonal antibodies
- Known interstitial lung disease or active non-infectious pneumonia
- Known central nervous system metastasis
- Other malignant tumors within the past 5 years except cured basal cell carcinoma of the skin and cervical cancer in situ
- Uncontrolled hypertension or hypertensive crisis
- Severe cardiovascular or cerebrovascular disease including specified heart conditions and arrhythmias
- Receiving thrombolysis or anticoagulation therapy except low-dose aspirin or low-molecular-weight heparin
- Clinically significant bleeding or bleeding tendency within 3 months before enrollment
- Tumor invasion of vital blood vessels with high risk of fatal bleeding
- Pleural effusion, ascites, or pericardial effusion requiring drainage unless stable after drainage
- Arterial or venous thrombosis events within 6 months before enrollment
- Major vascular disease requiring recent surgical repair or intervention
- Significant proteinuria confirmed by urine tests
- Active infection, fever over 38.5°C within 7 days before treatment, or elevated white blood cell count
- Congenital or acquired immune deficiency, positive hepatitis B or C markers above specified levels
- Recent live vaccination within 4 weeks before treatment or planned vaccination during study
- Other serious diseases or conditions that may affect study results or patient safety as judged by the researcher
AI-Screening
AI-Powered 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 1 year
Participants receive QL1706 plus nab-paclitaxel with or without bevacizumab as first-line treatment for recurrent or metastatic triple-negative breast cancer.
Visits every 6 weeks during treatment
Duration - Up to 3 years
Participants are monitored for safety and survival outcomes after treatment ends.
Periodic visits for safety and survival assessments
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
W
Wang Hongxia
T
Tao Zhonghua
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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