Phase II Study of Primary Paclitaxel Plus Gemcitabine in Patients With Stage II and III Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 44
- 主要终点
- To evaluate the clinical and pathologic responses to preoperative administration of Paclitaxel/Gemcitabine (PG)
研究概览
简要总结
This is an open labeled phase II single arm trial. The patients with clinical stage II and III will undergo core-needle biopsy of breast tumor for histologic diagnosis, immunohistochemical studies for estrogen receptor (ER), progesterone receptor(PR), HER-2/neu and others. PET or ultrasound results will determine the positivity of lymph node metastasis.
详细描述
Patients will be treated as follows:
PG x 4®operation®AC x 4®radiation ± tamoxifen/AI(postmenopausal)
Intravenous infusion of Paclitaxel 80 mg/m2, over 60 min, on D1 and D8 Followed by intravenous infusion of Gemcitabine 1200 mg/m2, over 30 min, on D1 and D8
The cycle repeats every 3 weeks for 4 times. Premedication includes antiemetics, dexamethasone, famotidine, pheniramine as routinely given.
After the operation, standard adjuvant chemotherapy (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2, every 3 weeks x 4 cycles) will be given.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients must have histologically confirmed and newly diagnosed breast cancer: node-positive stage IIA and any stage IIB, III. PET results will determine node positivity. If PET was not utilized, sonographically positive node should be confirmed cytologically by fine needle aspiration.
- •No prior hormonal, chemotherapy or radiotherapy is allowed.
- •No breast operation other than biopsy to make diagnosis is allowed.
- •Age: 18-years and older, not pregnant pre-, and postmenopausal women with good performance status (ECOG 0-1)
- •Adequate hematopoietic function: Absolute granulocyte count ³1500/mm3, platelet ³100,000/mm3, Hemoglobin ³ 10 g/mm3
- •Adequate renal function: Serum creatinine £ 1.5 mg/dl
- •Adequate hepatic function: total bilirubin: £ 1.5 mg/dl, AST/ALT: £ two times normal, Alkaline phosphatase: £ two times normal
- •Adequate cardiac function: normal or nonspecific EKG taken within 1 mo of enrollment
- •Adequate mental function to understand and sign the consent
排除标准
- •Patients who received hormonal, chemotherapy or radiotherapy for breast cancer
- •Patients who underwent surgery for breast cancer
- •Patients with node-negative stage IIA breast cancer
- •Patients who have history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer
研究组 & 干预措施
Paclitaxel/Gemcitabine
paclitaxel 80 mg/m2 (day 1, 8) and gemcitabine 1200 mg/m2 (day1, 8) every 3 weeks, 4 cycles
干预措施: Paclitaxel/Gemcitabine (Drug)
结局指标
主要结局
To evaluate the clinical and pathologic responses to preoperative administration of Paclitaxel/Gemcitabine (PG)
时间窗: two years
次要结局
- To assess breast conserving rate To evaluate the disease free survival (DFS) and overall survival (OS) of patients who received preoperatively PG To investigate the toxicity profiles of PG(two years)