A Prospective, Single Arm, Multicenter, Phase II Trial of Gemcitabine Plus Cisplatin in the Treatment of Patients With Non-pCR Triple Negative Breast Cancer Following Neoadjuvant Chemotherapy
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Disease free survival
研究概览
简要总结
This is a prospective, open-lable phase II clinical trial evaluating the effectiveness and safety of gemcitabine plus cisplatin as adjuvant treatment for non-pCR TNBC patients after standard neoadjuvant chemotherapy.
详细描述
This is a prospective, open-lable phase II clinical trial evaluating the effectiveness and safety of gemcitabine plus cisplatin as adjuvant treatment for non-pCR TNBC patients after standard neoadjuvant chemotherapy. Non-pCR TNBC patients who completed 6-8 cycles of standard neoadjuvant chemotherapy will be included in this study and receive 4 cycles of GP regimen chemotherapy(cisplatin 75 mg/m² d1 and gemcitabine 1250 mg/m² d1,8, every 3 weeks). Our primary endpoint is disease free survival (DFS). Secondary end points include overall survival (OS), recurrence free survival (RFS), distant disease free survival (DDFS)rates 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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 70 years old
- •Patients with histologically confirmed unilateral invasive ductal carcinoma(according to WHO histologically type)
- •Tumor clinical staged as IIB-IIIB before neoadjuvant chemotherapy (according to the 7th AJCC edition).
- •After standard treatment (6-8 cycles) of neoadjuvant chemotherapy (plan formulated by the attending doctor, including anthracycline and paclitaxel drugs, must not contain platinum), assessed by the surgery, the original site for non - pCR (MP class 1-4) or lymph nodes are still positive for patients.
- •No gross or microscopic tumor residual after resection.
- •Patients with clear ER/PR/Her2 receptor, and ER/PR/Her2 are all negative(Specific definition: immunohistochemical detection of ER < 1% positive tumor cell is defined as the ER negative, PR < 1% positive tumor cells is defined as the PR negative, Her2 0-1 or Her2 2 + but after FISH or CISH tested negatie for c (no amplification) is defined as the Her2-negative).
- •No evidence of distant metastasis in the clinical or radiological aspects of preoperative. examination,that is M
- •Patients without peripheral neuropathy or I peripheral neurotoxicity.
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤
- •Patients recovered well after surgery, at least 1 weeks after the operation.
- •Adequate marrow: White blood cells count≥3000/μL,neutrophil count ≥1500/μL, hemoglobin ≥9g/dL and platelet count ≥75000/μL.
- •Normal liver function test: Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) ≤ 1.5×upper limit of normal (ULN) concomitant with alkaline phosphatase (ALP) ≤ 2.5×ULN, and bilirubin ≤ 1.5ULN.
- •Adequate renal function: Serum creatinine ≤ 1.5ULN.
- •Contraception during the treatment of child-bearing women.
- •Adequate cardiac function :Left ventricular ejection fraction (LVEF) > 50%.
- •Patients must be informed of the investigational nature of this study and give written informed consent.
- •Patients without serious heart, lung, liver, kidney and other important organs disease history.
- •Patients have good compliance.
排除标准
- •Patients with bilateral breast cancer or carcinoma in situ(DCIS/LCIS).
- •Metastasis of any part except axillary lymph nodes.
- •Clinical or imaging suspicion of the contralateral breast is malignant but not confirmed, requiring biopsy.
- •There have been malignant tumors (except for basal cell carcinoma and carcinoma in situ of cervix) in the last five years, including breast cancer.
- •Patients have been enrolled in other clinical trials.
- •Patients with severe systemic illnesses and/or uncontrolled infections are unable to join the study.
- •Patients with severe cardio-cerebrovascular disorders (e.g., unstable angina pectoris, chronic heart failure, uncontrollable hypertension >160/100mmgh, myocardial infarction or cerebrovascular accident) in the first 6 months of randomization.
- •Pregnant lactating women (child-bearing women must be negative for pregnancy test within 14 days prior to first delivery, if positive, the pregnancy should be excluded by ultrasound.)
- •Child-bearing women who are unwilling to take effective contraceptive measures in the course of research.
- •Patients with mental illness, cognitive impairment, inability to understand test protocols and side effects, and those who fail to complete the trial programme and follow-up work (a systematic assessment is required before the trial).
- •Persons without personal freedom and independent civil capacity.
研究组 & 干预措施
GP group
Patients should receive four cycles of GP regimen (cisplatin at 75 mg/m2 iv infusion on day 1 plus gemcitabine at 1250 mg/m2 iv infusion over 30 min on day 1 and 8 every 3 weeks).
干预措施: Gemcitabine (Drug)
GP group
Patients should receive four cycles of GP regimen (cisplatin at 75 mg/m2 iv infusion on day 1 plus gemcitabine at 1250 mg/m2 iv infusion over 30 min on day 1 and 8 every 3 weeks).
干预措施: Cisplatin (Drug)
结局指标
主要结局
Disease free survival
时间窗: 3-year
The length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer
次要结局
- Overall survival(5year)(5-year)
- Recurrence free survival(3-year)
- Distant disease free survival(3-year)
- Overall survival(3-year)
- Disease free survival(5year)(5-year)
- Distant disease free survival(5year)(5-year)
- Recurrence free survival(5year)(5-year)