Neoadjuvant Anthracycline Followed by Toripalimab Combined With Nab-paclitaxel in Patients With Early Triple-negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Total Pathologic complete response (tpCR)
研究概览
简要总结
This study is to evaluate the efficacy and safety for dose-dense epirubicin hydrochloride with cyclophosphamide followed by nanoparticlealbumin-bound paclitaxel with PD-1 in neoadjuvant therapy for patients with triple-negative breast cancer, and to explore the predictive value of biological markers for the treatment.
详细描述
This study is an open single arm study, which would undergo optimal two stage designs. 60 patients who are diagnosed with triple-negative breast cancer would have dose-dense epirubicin hydrochloride with cyclophosphamide followed by nanoparticlealbumin-bound paclitaxel with PD-1 regimen for neoadjuvant therapy if they meet the eligibility criteria. The regimen is as follows: epirubicin hydrochloride (90mg/m2, d1) plus cyclophosphamide (600mg/m2, d1) every 14 days as one cycle for 4 cycles, followed by nanoparticlealbumin-bound paclitaxel (125mg/m2, d1) per week for 3 weeks as one cycle for 4 cycles, and Toripalimab (240mg, d1) every 3 weeks as one cycle for 4 cycles. pathological complete response would be the primary endpoint. The change of biological markers and safety of the regimen would also be evaluated.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 70 years old, female.
- •Patients with histologically confirmed unilateral primary invasive breast cancer who meet the criteria of cT2-4NanyM
- •Patients with ER negative and PR negative by immunohistochemistry (IHC), and HER-2 negative disease. HER2-negative disease was defined as follows: disease whose HER-2 is 1+ or negative by IHC, or fluorescence in situ hybridization (FISH) is negative if IHC is 2+.
- •According to the RECIST 1.1 criteria, there is at least one measurable objective lesion.
- •Eastern Cooperative Oncology Group (ECOG) performance score 0-
- •Baseline left ventricular ejection fraction (LVEF) is greater than or equal to (>/=) 55%.
- •Bone marrow function is required as follows: neutrophils are more than or equal to (>/=) 1.5×109/L, platelets more than or equal to (>/=) 100×109/L, and hemoglobin more than or equal to (>/=) 90g/L.
- •Hepatic and renal function are required as follows: serum creatinine is less than or equal to (</=) 1.5 times of upper limits of normal (ULN), aspartate transaminase (AST) and alanine aminotransferase (ALT) less than or equal to (</=) 2.5 times of ULN, and total bilirubin less than or equal to (</=) 1.5 times of ULN or </= 2.5 times of ULN if patient is with Gilbert's syndrome.
- •With good compliance with the planned treatment, are able to understand the follow-up procedures of this study and sigh the informed consent form.
- •Signed informed consent.
排除标准
- •Received radiotherapy, chemotherapy, surgery or other targeted and immunotherapy for triple-negative breast cancer before enrollment.
- •With heart disease classified as New York Heart Association class (NYHA) grade II or above (including grade II) are identified by the investigator.
- •With severe systemic infection or those with other serious illnesses.
- •Known to be allergic or intolerant to chemotherapy drugs or their excipients.
- •With a history of autoimmune diseases or those using glucocorticoids or immunosuppressive drugs.
- •With known active stage of HBV or HCV infection or hepatitis B DNA ≥500, or patients with chronic abnormal liver function.
- •With a history of abnormal thyroid function.
- •With grade ≥ 2 peripheral neuropathy.
- •With a clear history of neurological or mental disorders, including epilepsy or dement.
- •Previous non-breast malignancy within 5 years prior to study entry excluding healed cervical carcinoma in situ and non-melanoma skin cancer.
- •History of other malignant tumors within the past 5 years, excluding cured cervical carcinoma in situ and non-melanoma skin cancer.
- •Pregnancy or lactation, and patients of childbearing potential who refuse to use adequate contraception during the course of this study.
- •Prior participation in other studies within 30 days prior to the administration of the first dose of the investigational drug.
- •Patients who are deemed to be unsuitable for this study by investigators.
研究组 & 干预措施
EC-ABX/PD-1
Patients who are treated with epirubicin hydrochloride andcyclophosphamide followed by nanoparticlealbumin-bound paclitaxel and Toripalimab
干预措施: epirubicin hydrochloride (Drug)
EC-ABX/PD-1
Patients who are treated with epirubicin hydrochloride andcyclophosphamide followed by nanoparticlealbumin-bound paclitaxel and Toripalimab
干预措施: Cyclophosphamide (Drug)
EC-ABX/PD-1
Patients who are treated with epirubicin hydrochloride andcyclophosphamide followed by nanoparticlealbumin-bound paclitaxel and Toripalimab
干预措施: Albumin bound paclitaxel (Drug)
EC-ABX/PD-1
Patients who are treated with epirubicin hydrochloride andcyclophosphamide followed by nanoparticlealbumin-bound paclitaxel and Toripalimab
干预措施: Toripalimab (Drug)
结局指标
主要结局
Total Pathologic complete response (tpCR)
时间窗: Immediately after the surgery
Defined as no residual invasive cancer cells are found in the pathological examination of breast and axillary lymph node; if only residual in situ cancer cells are present in the surgical specimens, it can also be considered as achieving a pathological complete response.
次要结局
- Breast pathologic complete response (bpCR: ypT0/is) rate(Immediately after the surgery)
- Objective response rate (ORR)(Immediately after the surgery)
- Breast conservative surgery rate(Immediately after the surgery)
- Event-free survival (EFS)(Approximately 3 years)
- Adverse events (AEs)(During this period between the start of randomization and the last visit, approximately 3 years)
- Change in immune-related tissue biomarkers(At baseline, at the end of first 2 cycles (each cycle is 14 days) and immediately after the surgery)
研究者
Jiong Wu
Professor, Department of Breast Surgery Vice President, Cancer Hospital, Fudan University
Fudan University