Randomised, Multicenter Phase II Study in Patients With Metastatic Breast Cancer With Vinorelbine Plus Gemcitabine Versus Vinorelbine Plus Cisplatin
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 主要终点
- Progression Free Survival
研究概览
简要总结
Development of an active second-line treatment option for metastatic breast cancer patients previously pre-treated with anthracyclines and taxanes in neoadjuvant, adjuvant or palliative settings.For each randomisation arm, 100 patients will be included. The trial was performed as a 2-stage phase II study according to the optimal design by Simon with overall response rate as the primary objective.
Study Design:
Arm A Vinorelbine 25 mg/m2 d1, 8;Gemcitabine 1000 mg/m2 d1, 8 q 3 weeks Arm B Vinorelbine 25 mg/m2 d1, 8;Cisplatin 25 mg/m2 d1, 2,3 q 3 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Histologically confirmed metastatic breast cancer
- •All patients were required to give written informed consent
- •To have received a previous treatment with anthracyclines and taxanes
- •Previous radiotherapy is allowed, whenever the radiated area is not the only disease location
- •At least 4 weeks since the last previous antineoplastic treatment
- •Patients must have recovered from all previous toxicities
- •Karnofsky Performance status >= 70%
- •Adequate hematological, renal, cardiac and hepatic function
- •Life expectancy of at least 12 weeks
- •Patients able to comply and to receive an adequate follow-up
排除标准
- •Only bone metastases
- •Active infection
- •Previous treatment with one of the study drugs
- •Application of other cytotoxic chemotherapy
- •Insufficient renal function (creatinine clearance < 60ml/min)
- •Clinically unstable brain metastasis
- •Pregnancy or lactation
- •Other primary malignancies (other than carcinoma-in-situ of the cervix or adequately treated basal cell cancer of the skin)
- •Abnormal liver function (bilirubin > 2.0-fold upper normal limit (UNL); Alanine aminotransferase and aspartate aminotransferase >2.5-fold UNL). In patients with hepatic metastasis, a value of Alanine aminotransferase and aspartate aminotransferase of up to 5-fold UNL is permitted
- •Second malignancy (except for cervix carcinoma in situ or skin carcinoma - no melanoma- with an adequate treatment). Previous malignancies are allowed if disease-free survival is superior to 5 years, except for renal carcinoma or melanoma
研究组 & 干预措施
A
Vinorelbine 25 mg/m2 d1, 8; Gemcitabine 1000 mg/m2 d1, 8 q 3 weeks
干预措施: Vinorelbine (Drug)
A
Vinorelbine 25 mg/m2 d1, 8; Gemcitabine 1000 mg/m2 d1, 8 q 3 weeks
干预措施: Gemcitabine (Drug)
B
Vinorelbine 25 mg/m2 d1, 8; Cisplatin 25 mg/m2 d1,2,3 q 3 weeks
干预措施: Vinorelbine (Drug)
B
Vinorelbine 25 mg/m2 d1, 8; Cisplatin 25 mg/m2 d1,2,3 q 3 weeks
干预措施: Cisplatin (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months
次要结局
- Overall Survival(Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months)
- Duration of response(Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months)
- Incidence of Treatment-Emergent Adverse Events(Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months)
- Clinical Benefit Rate(Patients enrolled will receive study medication until disease progression, unaccettable toxicity, withdrawal of consent or death, whichever comes first, assested up to 30 months)
研究者
Zhiyong Yu
Director of the Breast Surgery Ⅰ
Shandong Cancer Hospital and Institute