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New treatment option for TNBC, Triple Negative Breast Cancer
Official 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
ClinicalTrials.gov ID: NCT07601178
What this study is testing
What is TREATMENT GROUP（QL1706 + anlotinib+ nab-paclitaxel ）?
TREATMENT GROUP（QL1706 + anlotinib+ nab-paclitaxel ） is an investigational medicine, being studied as a potential treatment for tnbc, triple negative breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a single-arm, multicenter, prospective phase II clinical trial designed to evaluate the efficacy and safety of QL1706 in combination with anlotinib hydrochloride and nab-paclitaxel as first-line treatment for advanced triple-negative breast cancer. A total of 34 participants with first-line advanced triple-negative breast cancer are enrolled in this study: Enrolled participants receive QL1706 (5 mg/kg, Q3W, day 1) + anlotinib (12 mg per dose, QD, days 1-14, Q3W) + nab-paclitaxel (125 mg/m², days 1 and 8, Q3W), with a 21-day cycle.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Participants voluntarily join the study, sign the informed consent form, and agree to strictly comply with the study protocol requirements.
- Female patients aged between 18 and 75 years.
- Confirmed by histopathological examination as advanced triple-negative invasive breast cancer, meeting the following criteria: pathological type...
- TNBC patients with initial diagnosis of stage IV (according to AJCC 8th edition) or recurrent/metastatic disease who are not suitable for surgery...
- Suitable for nab-paclitaxel treatment.
You likely can't join if
- Known history of severe allergic reactions to QL1706, anlotinib, nab-paclitaxel, or any of their excipients.
- Inability to swallow oral medications, or any gastrointestinal disorder that may interfere with the absorption and metabolism of the study drugs.
- Symptomatic brain/leptomeningeal metastases and/or spinal cord metastases.
- Active or potentially relapsing autoimmune disease, with the following exceptions: vitiligo, alopecia, psoriasis, or eczema not requiring systemic...
- Major surgery within 3 weeks before study initiation, or failure to recover from surgery.
- History of organ transplantation or autologous/allogeneic stem cell transplantation.
See the full eligibility criteria
- Participants voluntarily join the study, sign the informed consent form, and agree to strictly comply with the study protocol requirements.
- Female patients aged between 18 and 75 years.
- Confirmed by histopathological examination as advanced triple-negative invasive breast cancer, meeting the following criteria: pathological type triple-negative, specifically: ER negative (IHC \<1%), PR negative (IHC...
- TNBC patients with initial diagnosis of stage IV (according to AJCC 8th edition) or recurrent/metastatic disease who are not suitable for surgery, and have not received prior systemic therapy for advanced disease. Prior...
- Suitable for nab-paclitaxel treatment.
- At least one measurable tumor lesion according to RECIST 1.1 criteria.
- Expected survival ≥3 months.
- ECOG performance status 0 or 1.
- Adequate organ function, including: 1)Hematology: Absolute neutrophil count (ANC) ≥1.5×10⁹/L; platelet count (PLT) ≥100×10⁹/L; hemoglobin (HB) ≥90 g/L. 2)Liver function: Total bilirubin ≤1.5×ULN; AST and ALT ≤2.5×ULN...
- Known history of severe allergic reactions to QL1706, anlotinib, nab-paclitaxel, or any of their excipients.
- Inability to swallow oral medications, or any gastrointestinal disorder that may interfere with the absorption and metabolism of the study drugs.
- Symptomatic brain/leptomeningeal metastases and/or spinal cord metastases.
- Active or potentially relapsing autoimmune disease, with the following exceptions: vitiligo, alopecia, psoriasis, or eczema not requiring systemic treatment; hypothyroidism due to autoimmune thyroiditis requiring only...
- Major surgery within 3 weeks before study initiation, or failure to recover from surgery.
- History of organ transplantation or autologous/allogeneic stem cell transplantation.
- Known or self-reported human immunodeficiency virus (HIV) infection.
- HBV-DNA positive or HCV-DNA positive (copy number \>10³).
- Prior treatment with any agent targeting the mechanism of tumor immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies), immune checkpoint...
- Prior treatment with anti-angiogenic targeted therapy.
- Hypertension that cannot be well controlled with a single antihypertensive medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90 mmHg).
- Arterial/venous thrombotic events (e.g., cerebrovascular accident including transient ischemic attack, deep vein thrombosis, pulmonary embolism) within 6 months before enrollment.
- Presence of other malignancies within 5 years before enrollment, except for TNBC.
- Tumor invasion or compression of surrounding major blood vessels or organs.
- Active central nervous system (CNS) metastatic lesions.
- Clinically significant pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
- History of myocarditis, cardiomyopathy, or malignant arrhythmias.
- History of significant bleeding tendency or coagulation dysfunction.
- History of esophageal-gastric varices, severe ulcer, non-healing wound, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6...
- Known active tuberculosis (TB).
- History of or current non-infectious pneumonitis/interstitial lung disease requiring systemic corticosteroid therapy.
- Major surgery or severe trauma within 30 days before the first dose, or planned major surgery within 30 days after the first dose; minor local surgery within 3 days before the first dose.
- Platelet or red blood cell transfusion within 4 weeks before initiation of study drug treatment.
- Receipt of live vaccine within 4 weeks before the first dose, or planned receipt of live vaccine during the study.
- Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study.
- Patients judged by the investigator to be unsuitable for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.