临床试验/NCT01917279

NCT01917279Unknown3 期

A Randomized Phase III Study of Metronomic vs. Intermittent Capecitabine Maintenance Therapy Following First-line Capecitabine and Docetaxel Therapy in HER2-negative Metastatic Breast Cancer

Binghe Xu1 个研究点分布在 1 个国家目标入组 280 人开始时间: 2013年10月最近更新: 2020年7月23日

适应症

干预措施

试验速览

阶段: 3 期
发起方
入组人数: 280
试验地点: 1
主要终点: Progression Free Survival (PFS)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

It is a phase III trial to explore the efficacy and safety of metronomic chemotherapy with Capecitabine versus intermittent Capecitabine as maintenance therapy following first-line Capecitabine plus Docetaxel chemotherapy in treatment of HER2-negative metastatic breast cancer(mBC).

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 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Signed informed consent obtained prior to initiation of any study-specific procedures or treatment as confirmation of the patient's awareness and willingness to comply with the study requirements.
•Female patients aged ≥ 18 years.
•Histologically confirmed and documented HER2-negative metastatic breast cancer.
•Previously untreated first-line chemotherapy.
•Patients with at least one measurable lesion according to RECIST criteria at study entry.
•Documented ER/PgR status.
•Prior hormone therapy for metastatic disease is allowed but must stop before study entry.
•Life expectancy of ≥12 weeks

排除标准

•Previous chemotherapy for metastatic breast cancer.
•Prior adjuvant/neoadjuvant chemotherapy within 6 months prior to first study treatment administration.
•Prior (radical)radiotherapy for the treatment of metastatic disease or major surgical procedure within 28 days prior to the first study treatment,
•Inadequate bone marrow function: absolute neutrophil count (ANC): <1.5 x 109/L, platelet count<75 x 109/L or hemoglobin <100g/L.
•Inadequate liver or renal function, defined as:
•Serum (total) bilirubin >2 x the upper limit of normal (ULN) for the institution
•AST/SGOT or ALT/SGPT >2.5 x ULN (>5 x ULN in patients with liver metastases)
•ALP >2.5 x ULN at baseline (>5 x ULN in patients with liver metastases).
•Serum creatinine>140umol/L.
•Pregnant or lactating females.
•Her-2 positive (ICH +++ or FISH positive).
•Symptomatic cerebral parenchyma and/or leptomeningeal metastases.
•Other malignancy within the last 5 years, except for adequately treated carcinoma in situ of the cervix or squamous carcinoma of the skin, or adequately controlled limited basal cell skin cancer.
•Pre-existing peripheral neuropathy ≥grade 1 according NCI CTCAE 4.
•Mental disease or other conditions affecting on the compliance of patients.
•Other serious disease or medical condition:
•History of uncontrolled seizures, CNS disorders or psychiatric disability judged by the Investigator to be clinically significant precluding informed consent.
•Congestive heart failure, or unstable angina, myocardial infarction within ≤6 months prior to the first study treatment, uncontrolled hypertension and high risk, uncontrolled arrhythmias.
•Uncontrolled acute infection
•Inability to take or absorption oral medications.
•Concurrent or within 30 days using drugs of other clinical trials.
•Previous treatments containing Capecitabine (whether adjuvant or palliative treatment).
•Previous treatments containing docetaxel within 12 months.
•Known hypersensitivity to any of the study treatments or excipients.
•Any other conditions the research consider not appropriate to take part in the trial.

研究组 & 干预措施

Intermittent Capecitabine

Active Comparator

Capecitabine 1000 mg/m2 twice daily on days 1-14 of each 3-week cycle.

干预措施: Docetaxel plus Capecitabine (Drug)

Intermittent Capecitabine

Active Comparator

Capecitabine 1000 mg/m2 twice daily on days 1-14 of each 3-week cycle.

干预措施: Intermittent Capecitabine (Drug)

Metronomic Capecitabine

Experimental

Capecitabine 500 mg three times daily on days 1-21 of each 3-week cycle

干预措施: Docetaxel plus Capecitabine (Drug)

Metronomic Capecitabine

Experimental

Capecitabine 500 mg three times daily on days 1-21 of each 3-week cycle

干预措施: Metronomic Capecitabine (Drug)

结局指标

主要结局

Progression Free Survival (PFS)

时间窗: up to 36 months

Time from randomization to progression or death (whichever occurred first).

次要结局

Adverse events (AEs)(up to 36 months)
Overall survival (OS):(up to 52 months)
Overall Response rates (ORR)(up to 36 months)
Clinical Benefit rate (CBR)(up to 36 months)
Time to Progression (TTP)(up to 36 months)
QoL(up to 36 months)

研究者

发起方

Binghe Xu

申办方类型

Unknown

责任方

Sponsor Investigator

主要研究者

Binghe Xu

Director of Medical Department

Chinese Academy of Medical Sciences

研究点 (1)

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