Phase II Pharmacogenomic and Clinical Trial for the Administration of Gemcitabine-doxorubicin-paclitaxel (GAT) as Neoadjuvant Treatment of Patients With Stage III Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 10
- 主要终点
- Pathological complete response (pCR) rate
研究概览
简要总结
This is a multicenter, open-label, phase II trial to assess the efficacy of the GAT neoadjuvant regimen in patients with stage III breast cancer.
详细描述
2 treatment cycles of chemotherapy (one cycle = 2 weeks) must be administered to each patient before breast surgery.
The required number of patients has been calculated following Simon's method. 43 patients will be enrolled in two phases: first, 29 patients must be enrolled, and at least 2 pathological complete responses obtained. Patients recruitment will continue until 43 patients have been enrolled. Assumptions are that there is a 95% probability to obtain a rate of pathological complete responses of at least 10%.
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
- •Stage III breast cancer disease, with histological confirmation by true-cut or open-biopsy.
- •Ages between 18 and 75 years old. Patients older than 70 must have an adequate quality of life to be eligible.
- •Patients cannot have received previous treatment with chemotherapy, hormone therapy, radiotherapy or immune therapy.
- •Performance status of 0,1, 2 Eastern Cooperative Oncology Group (ECOG).
- •At least a 6 month life expectancy.
- •Neutrophils > 1500; platelets > 100000; haemoglobin > 10 mg/dL.
- •Adequate renal and hepatic functions, with serum creatinine < 1.2 mg/dl and total bilirubin < 2 mg/dl.
- •Adequate contraceptive methods during the study and up to 3 months after.
- •Adequate cardiac function assessed by physical exam, electrocardiogram and left ventricular ejection fraction > 55%.
排除标准
- •Inflammatory carcinoma or stage I, II or IV breast cancer disease.
- •Active infection.
- •Other neoplasms except for basal skin carcinoma or cervical in situ carcinoma adequately treated. Other previous neoplasms are allowed if diagnosed and treated more than 5 years before study registration.
- •Concomitant serious disease provoking organ failure (heart, renal, hepatic, respiratory).
- •Pre-existing motor or sensorial neuropathy > grade
- •Inability for treatment compliance.
- •History of hypersensitivity to compounds such as cremophor, cyclosporine or vitamin K.
- •History of arrhythmias or congestive heart failure, even when controlled; or active cardiac blocking of second or third grade.
- •History of myocardial infarction in the previous 6 months.
- •Hypertension not controlled.
- •Pregnant or lactating women.
研究组 & 干预措施
Gemcitabine + Adriamycine + Paclitaxel
Neoadjuvant chemotherapy consisted of adriamycine 40 mg/m2, administered on day 1 as an i.v. infusion. Paclitaxel 150 mg/m2 was administered on day 2 as an i.v infusion followed by gemcitabine 2000 mg/m2 as an i.v. infusion. The three drugs were administered every two weeks for 6 cycles.
干预措施: Gemcitabine (Drug)
Gemcitabine + Adriamycine + Paclitaxel
Neoadjuvant chemotherapy consisted of adriamycine 40 mg/m2, administered on day 1 as an i.v. infusion. Paclitaxel 150 mg/m2 was administered on day 2 as an i.v infusion followed by gemcitabine 2000 mg/m2 as an i.v. infusion. The three drugs were administered every two weeks for 6 cycles.
干预措施: Adriamycine (Drug)
Gemcitabine + Adriamycine + Paclitaxel
Neoadjuvant chemotherapy consisted of adriamycine 40 mg/m2, administered on day 1 as an i.v. infusion. Paclitaxel 150 mg/m2 was administered on day 2 as an i.v infusion followed by gemcitabine 2000 mg/m2 as an i.v. infusion. The three drugs were administered every two weeks for 6 cycles.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Pathological complete response (pCR) rate
时间窗: Up to week 15
pCR is defined as no invasive cells identifiable in breast sections at surgery. Response will be measured by physical exam and breast imaging before surgery and will be evaluated according to the World Health Organization (WHO) criteria. Pathological response after surgery, will be based on the proportion of remaining tumor and post-chemotherapy changes, evaluating separately the response in the breast and in the axilla lymph nodes.
次要结局
- Overall response rate (ORR)(Up to week 12)
- Conservative surgery rate(Up to week 15)
- The Number of Participants Who Experienced Adverse Events (AE)(Through study treatment up to surgery)
- Disease-free survival(Up to 5 years since surgery)
- Tissue molecular markers and their correlation with response(Up to week 15)