NCT06636981招募中2 期
All Trans Retinoic Acid Combined with Toripalimab+Chemotherapy for Locally Advanced Inoperable or Metastatic Triple Negative Breast Cancer：a Multi-center, Multi-cohort Phase II Trial
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 129
- 试验地点
- 2
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
All trans retinoic acid Combined with Toripalimab+Chemotherapy for Locally Advanced inoperable or Metastatic Triple Negative Breast Cancer：a multi-center, multi-cohort phase II trial
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •The subjects voluntarily participate and sign a written informed consent form;
- •Age ≥ 18 years old;
- •For locally advanced inoperable or metastatic breast cancer confirmed by histology (according to AJCC 8th edition staging), the histology and pathology clearly showed that ER, PR, Her-2 were negative. If there was metastatic lesion pathology, the metastatic lesion histology and pathology should prevail. The definition of ER and PR negativity is: IHC ER<1%, IHC PR<1%. Her-2 negativity is defined as: immunohistochemical detection of Her-2 (-) or (1+), Her-2 (2+) must undergo FISH testing and the result is negative, Her-2 (-) or (1+) can choose to undergo FISH testing and the result is negative;
- •According to RECIST 1.1 criteria for solid tumor evaluation, there must be at least one measurable lesion;
- •Cohort 1: For locally advanced non operable or metastatic TNBC that has not been previously treated, intravenous chemotherapy and anti-tumor therapy may be used during previous neoadjuvant and/or adjuvant therapy stages, provided that the interval between the end of neoadjuvant and/or adjuvant therapy and the occurrence of recurrence/metastasis is ≥ 12 months; Cohort 2: Local late stage inoperable or metastatic TNBC with previous treatment failures of at least one line or above;
- •All subjects should undergo tumor lesion biopsy during the screening period to obtain sufficient qualified tumor tissue specimens for retrospective biomarker analysis (including PD-L1 expression levels) in their cohort. If subjects are unable to undergo biopsy, they should provide tumor samples or unstained sections (3-5 μm) that have been fixed in formalin and embedded in paraffin (FFPE) closest to the start of the study treatment (up to 24 months) for corresponding biomarker analysis;
- •The main organ function is good, the relevant examination indicators within 14 days before treatment meet the following requirements:
- •Without blood transfusion, platelet count ≥ 100 × 10^9/L, hemoglobin ≥ 90g/L, neutrophil count (ANC) ≥ 1.5 × 10^9/L AST and ALT ≤ 2.5 x upper limit of normal (ULN), ≤ 5 x ULN if liver metastasis is present, total bilirubin ≤ 1.5 x ULN, serum creatinine (Cr) ≤ 1.5 ULN, or creatinine clearance rate ≥ 60mL/min (Cockcroft Gault formula)
- •Expected survival period ≥ 3 months;
- •ECOG PS score: 0-1 points;
- •Non surgical sterilization, male patients with women of childbearing age or partners of childbearing age, are required to use a medically approved contraceptive measure (such as intrauterine device, contraceptive pill, or condom) during the study treatment period and within 6 months after the end of the study treatment period; Female patients of childbearing age who undergo non-surgical sterilization must have a negative serum HCG test within 72 hours prior to enrollment in the study.
排除标准
- •Individuals who have previously been treated with PD-1 or PD-L1 monoclonal antibodies; Participants in cohort 1 who have previously used albumin paclitaxel;
- •Individuals known to be allergic to any of the drugs in the study;
- •Patients who have hypersensitivity reactions to other vitamin A drugs;
- •History of active autoimmune diseases requiring systemic treatment in the past 2 years (e.g. corticosteroids (dose ≤ 10mg/day, except for prednisone or other effective hormones) or immunosuppressive drugs);
- •Diagnosed with immune deficiency or undergoing systemic steroid therapy (excluding doses ≤ 10mg/day of prednisone or other effective hormones) or any other form of immunosuppressive therapy within 7 days prior to enrollment;
- •There are other known malignant tumors that have progressed or require active treatment in the past 5 years. Excluding malignant tumors that can be treated locally and have already been cured, such as skin basal cell carcinoma, skin squamous cell carcinoma, and cervical cancer in situ;
- •Known to have active central nervous system (CNS) metastases;
- •History of non infectious pneumonia requiring steroid hormone therapy;
- •Active infections require systematic treatment;
- •There are serious uncontrolled hypertension, diabetes and hyperlipidemia;
- •History of II-IV congestive heart failure or myocardial infarction within 6 months prior to enrollment;
- •Individuals who tested positive for HIV during screening;
- •Active hepatitis (hepatitis B reference: HBsAg positive and HBV DNA ≥ 500 IU/ml; hepatitis C reference: HCV antibody positive and HCV copy number>upper limit of normal value);
- •Individuals with other serious acute or chronic physiological or mental problems;
- •Accepting any medication that is prohibited from being used in combination with the investigational drug, unless the medication has been discontinued within 7 days prior to enrollment;
- •Lactating women;
- •Individuals who have participated in clinical trials of other anti-tumor drugs within the past four weeks;
- •Inability to swallow, intestinal obstruction, or other factors that affect medication administration and absorption;
- •Any situation that other researchers consider unsuitable for participation in this study.
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: up to 2 years
During the combined therapy, tumor assessment (enhanced CT) is conducted every 3 cycles (6 weeks), and the efficacy is evaluated using the RECIST 1.1 criteria. ORR will be summarized as the proportion of subjects achieving objective tumor responses (complete response or partial response). ORR and its 95% confidence interval will be calculated.
次要结局
- Overall Survival (OS)(up to 2 years)
- Progression-Free Survival (PFS)(up to 2 years)
- Duration of Response (DOR)(up to 2 years)
- Adverse events(up to 2 years)
- Skin adverse reactions(up to 2 years)
- Biomarker analysis(up to 2 years)
研究者
Hongxia Wang
MD, Fudan University Shanghai Cancer Center
Fudan University
研究点 (2)
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