AK105 Plus Anlotinib Hydrochloride Combined With Albumin Paclitaxel as a First-line Therapy in Patients With Advanced Triple-negative Breast Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 42
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
This trial used a multicentre, single-arm design in which patients were treated with AK105 plus Anlotinib Hydrochloride combined with albumin paclitaxel. Patients included in this trial were advanced breast cancer with hormone receptor negative and Her2 negative. The primary endpoint is ORR, and the secondary endpoint is DCR, PFS, OS and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged 18-75 years old.
- •ECOG 0 or 1 point.
- •Advanced triple-negative invasive breast cancer :
- •The pathological classification is triple negative, specifically:
- •ER negative: IHC<1%.
- •PR negative: IHC<1%.
- •HER2 negative: IHC-/+ or IHC++ but FISH/CISH is negative.
- •Tumor staging: locally advanced or recurrent/metastatic breast cancer.
- •If the last chemotherapy drug in the previous adjuvant/neoadjuvant treatment stage is paclitaxel, paclitaxel liposome, paclitaxel albumin or docetaxel, it will take ≥6 months from the end of treatment to enrollment.
- •At least one objectively measurable lesion according to the RECIST 1.1 .
- •The main organs are functioning well, and the blood test results within 14 days before enrollment should meet the following requirements:
- •Routine blood test:
- •Hemoglobin (HB) ≥90 g/L.
- •Neutrophil count (ANC) ≥1.5×109/L.
- •Platelet count (PLT) ≥100×109/L.
- •Biochemical test:
- •Total bilirubin≤1.5×ULN (upper limit of normal).
- •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN; if there is liver metastasis, ALT and AST ≤ 5×ULN.
- •Serum creatinine (Cr) ≤1.5 ULN or creatinine clearance ≥60mL/min.
- •Must not be regnant.
- •Volunteer to participate in this study and sign an informed consent form.
排除标准
- •Pregnant, lactating or planning to become pregnant during the study period.
- •Allergic to any of the drugs in the study.
- •Previously received PD-1/PD-L1 antibody, CTLA-4 antibody, or anti-vascular targeted therapy.
- •Central nervous system (CNS) metastases.
- •Concomitant disease/medical history:
- •Patients with any known or suspected autoimmune diseases.
- •Hypertension.
- •Peripheral neuropathy ≥ Grade
- •Persons with a history of unstable angina or arrhythmia.
- •Active or uncontrolled serious infection .
- •History of immunodeficiency.
- •Active hepatitis B or C.
- •interstitial lung disease or non-infectious pneumonia.
- •Active tuberculosis.
- •Urine protein is ≥++, and 24-hour urine protein quantitative is >1.0g.
- •Suffered from other malignant tumors within 5 years before enrollment.
- •Unreduced toxicity .
- •Multiple factors that affect oral medications.
- •Abnormal coagulation function.
- •Major surgical treatment, open biopsy or traumatic injury within 4 weeks.
- •Tumor has invaded the periphery of important blood vessels.
- •Patients who have seizures.
- •Bleeding constitution or medical history.
- •Arterial/venous thrombotic events before enrollment or within 6 months.
- •Live attenuated vaccine vaccination within 28 days before the study.
- •Uncontrollable pleural, abdominal or pericardial effusion.
- •Other uncontrollable systemic diseases.
- •Other serious physical or mental diseases or laboratory abnormalities.
- •Patients who the researcher thinks are not suitable for this research.
- •Participated in clinical trials of other anti-tumor drugs within four weeks.
研究组 & 干预措施
AK105+Anlotinib Hydrochloride+Albumin Paclitaxel
AK105 200mg IV Day 1 Anlotinib Hydrochloride 12mg PO once daily on Days 1-14 Albumin paclitaxel 125mg/m2 IV Days 1, 8 Cycled every 21 days until disease progression, death or toxicity is intolerable (for subjects who can continue to tolerate the treatment, albumin paclitaxel lasts for at least 6 cycles)
干预措施: AK105 (Drug)
AK105+Anlotinib Hydrochloride+Albumin Paclitaxel
AK105 200mg IV Day 1 Anlotinib Hydrochloride 12mg PO once daily on Days 1-14 Albumin paclitaxel 125mg/m2 IV Days 1, 8 Cycled every 21 days until disease progression, death or toxicity is intolerable (for subjects who can continue to tolerate the treatment, albumin paclitaxel lasts for at least 6 cycles)
干预措施: Anlotinib hydrochloride (Drug)
AK105+Anlotinib Hydrochloride+Albumin Paclitaxel
AK105 200mg IV Day 1 Anlotinib Hydrochloride 12mg PO once daily on Days 1-14 Albumin paclitaxel 125mg/m2 IV Days 1, 8 Cycled every 21 days until disease progression, death or toxicity is intolerable (for subjects who can continue to tolerate the treatment, albumin paclitaxel lasts for at least 6 cycles)
干预措施: Albumin Paclitaxel (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: Up to approximately 10 months
Overall response rate (ORR) is defined as the proportion of patients with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1.
次要结局
- Overall Survival (OS)(Up to approximately 18 months)
- Disease Control Rate (DCR)(Up to approximately 10 months)
- Progression Free Survival (PFS)(Up to approximately 10 months)
研究者
Tao Sun
Director
Liaoning Tumor Hospital & Institute