Maintenance Versus Observation With 6 Cycles of Gemcitabine Plus Taxol Sequential Gemcitabine Single Agent in Patients With Metastatic Breast Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 267
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
The primary purpose of our study is to evaluate whether gemcitabine as a single agent is superior to observation in improving progression-free survival (PFS) in patients with metastatic breast cancer (MBC) who achieved disease control with an initial six cycles of PG as their first-line treatment
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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, or Recurrent Breast Cancer
- •Age over 18 Years
- •ECOG Performance Status 0-2
- •Premenopausal or Postmenopausal Breast Cancer Patients With Measurable or Non-Measurable Lesions, Who Are Candidates for Chemotherapy
- •Life Expectancy ≥ 3 Months
- •Patients May Have Received Prior Neoadjuvant or Adjuvant Taxane Regimen as Long as it Has Been 12 Months Since Completion of Regimen.
- •Patients Either May or May Not Have a Prior Anthracycline Containing Regimen.
- •Prior Hormonal Therapy as a Treatment of Metastatic Disease is Allowed. But Antitumoral Hormonal Therapy Must be Terminated Prior to Enrollment(up to the Date of Randomization)
- •Prior Radiation Therapy Allowed as Long as < 25% of the Bone Marrow Has Been Treated,and the Patients Must Have Recovered From the Acute Toxic Effects of the Treatment Prior to Study Enrollment.Prior Radiation to the Whole Pelvis is Not Allowed. Prior Radiotherapy Must be Completed 4 Weeks Before Study Entry.
- •Adequate Bone Marrow Function (≥ ANC 1,500/ul, ≥ Platelet 100,000/ul, ≥ Hemoglobin 9.0 g/dl)
- •Adequate Renal Function (≤ Serum Creatinine 1.5 mg/dl or CCr ≥ 50 ml/Min)
- •Adequate Liver Function (≤ Serum Bilirubin 1.5 mg/dl, ≤ AST/ALT x 3 Upper Normal Limit)
- •No Prior History of Chemotherapy for Metastatic, Recurrent Breast Cancer
- •Written Informed consent
排除标准
- •Serious Uncontrolled Intercurrent Infections
- •Serious Intercurrent Medical or Psychiatric Illness, Including Active Cardiac Disease
- •Pregnancy or Breast Feeding
- •Second Primary Malignancy(Except Cancer of Cervix or Skin or Other Malignancy Treated at Least 5 Years Previously With no Evidence of Recurrence)
- •Documented Parenchymal or Leptomeningeal Brain Metastasis
- •Peripheral Neuropathy ≥ Grade 2
- •Prior Treatment With Gemcitabine Will Not be Allowed.
- •HER-2 Overexpressing Breast Cancer and Concomitant Trastuzumab Treatment is Not Allowed
结局指标
主要结局
PFS
时间窗: From randomization to disease progression
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years
PFS(progression free survival)
时间窗: the time from the date of randomization until the date of disease progression,assessed up to 3 years
PFS was defined as the time from the date of randomization until the date of disease progression at any site including distant metastasis or second primary tumors or death,assessed up to 3 years
次要结局
- OS(overall survival)(the time from date of randomization until the date of first documented death from any cause,assessed up to 3 years)
研究者
LiNanlin,Ph.D, Chief Physician,Clinical Professor
The department of Vascular endocrine surgery
Xijing Hospital