Actively Recruiting
QUEEN-APPLE: Phase II Study of Iparomlimab and Tuvonralimab (QL1706) Combined With Anlotinib Hydrochloride and Nab-Paclitaxel as First-Line Treatment for Advanced Triple-Negative Breast Cancer
Led by Jiangsu Cancer Institute & Hospital · Updated on 2026-05-22
34
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the combination of QL1706 with anlotinib hydrochloride and nab-paclitaxel as a first treatment for advanced triple-negative breast cancer in a phase II clinical trial. This study involves 34 participants who have not received prior systemic therapy for advanced disease and aims to assess the safety and effectiveness of this treatment approach. The trial is led by Jiangsu Cancer Institute & Hospital and focuses on patients with specific tumor characteristics confirmed by pathology. Participants receive QL1706 at 5 mg/kg on day 1 every 3 weeks, anlotinib 12 mg daily from days 1 to 14 every 3 weeks, and nab-paclitaxel 125 mg/m² on days 1 and 8 every 3 weeks in 21-day cycles. Treatment continues until disease progression, unacceptable side effects, investigator decision, participant withdrawal, or up to 2 years. The study includes a screening period up to 28 days before treatment starts, followed by the treatment period and then a follow-up phase. During the study, participants undergo regular safety assessments every 3 weeks and tumor imaging every 6 weeks to monitor response. After stopping treatment, safety follow-up occurs about 30 days later, and survival status is tracked every 2 months by phone or other means. Participants provide samples and information at screening and during follow-up to support study evaluations. The main outcome measured is progression-free survival up to 36 months, with secondary outcomes including tumor response rate.
CONDITIONS
Brief Title
QUEEN-APPLE: A Single-Arm, Multicenter, Prospective Phase II Clinical Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Anlotinib Hydrochloride and Nab-Paclitaxel as First-Line Treatment for Advanced Triple-Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 75 years
- Histopathologically confirmed advanced triple-negative invasive breast cancer
- Patients with initial stage IV or recurrent/metastatic disease not suitable for surgery
- No prior systemic therapy for advanced disease; prior taxane-based (neo)adjuvant therapy allowed if no progression and at least 6 months disease-free interval
- Suitable for nab-paclitaxel treatment
- At least one measurable tumor lesion per RECIST 1.1 criteria
- Expected survival of at least 3 months
- ECOG performance status 0 or 1
- Adequate organ function including specific blood counts and liver and kidney function
- Use of appropriate contraception and negative pregnancy test for women of childbearing potential
- Voluntary informed consent and agreement to comply with study protocol
You will not qualify if you...
- History of severe allergic reactions to QL1706, anlotinib, nab-paclitaxel, or their components
- Inability to swallow oral medications or gastrointestinal disorders affecting drug absorption
- Symptomatic brain, leptomeningeal, or spinal cord metastases
- Active or relapsing autoimmune diseases except certain stable conditions
- Major surgery within 3 weeks before study start or not recovered from surgery
- History of organ or stem cell transplantation
- Known HIV infection
- Positive HBV-DNA or HCV-DNA above defined levels
- Prior treatment with tumor immunotherapy agents or anti-angiogenic therapies
- Uncontrolled hypertension or recent thrombotic events
- Other malignancies within 5 years except triple-negative breast cancer
- Tumor invasion/compression of major vessels or organs
- Active CNS metastatic lesions
- Significant pleural, pericardial effusion, or ascites requiring drainage
- History of serious heart conditions or bleeding disorders
- Recent severe gastrointestinal conditions
- Active tuberculosis
- Pneumonitis or interstitial lung disease requiring systemic steroids
- Recent major surgery or trauma
- Recent blood transfusions
- Recent or planned live vaccinations
- Pregnant, breastfeeding, or planning pregnancy during the study
- Any condition judged unsuitable by the investigator for participation
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) for screening and enrollment
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive a combination of QL1706, anlotinib, and nab-paclitaxel as first-line treatment for advanced triple-negative breast cancer.
Treatment days 1 and 8 every 21 days per cycle
Trial Site Locations
Total: 1 location
1
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
L
Lili Zhang
Y
Yuan Yuan
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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