JPRN-jRCTs011180026已完成3 期
A Phase III, Open Label, Randomized, Controlled, Multicenter Study, comparing Eribulin with S1, to assess Health-related Quality of Life (HRQoL) in the Treatment of Her2 negative Metastatic Breast Cancer Patients: RESQ - RESQ study
WATANABE KENICHI0 个研究点目标入组 302 人开始时间: 2019年3月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 302
研究概览
简要总结
It is hypothesized that the eribulin-treated arm is comparable to or superior to the S1 arm in overall HRQoL as measured by EORTC QLQ-C30 Global Health Status as a first- or second-line treatment for ER2-negative metastatic breast cancer. However, non-inferiority was not demonstrated statistically. Regarding the median overall survival, the Eribulin group was 35 months compared to 27.8 months in the S1 group (HR 0.69 [95% CI 0.50-0.95]; P=0.023), which was significantly longer in the Eribulin group.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 74age old（—）
- 性别
- All
入选标准
- •(i) Women with a histologically confirmed diagnosis of breast cancer.
- •(ii) One of the following conditions has to be met for a diagnosis of metastatic breast cancer.
- •(a) At the diagnosis of breast cancer, the patient has both primary breast cancer and distant metastasis (STAGE IV).
- •(b) The patient has breast cancer that has worsened or recurred in association with distant metastasis after treatment (after surgery and pre- and post- operative treatment); however, local recurrence is excluded
- •(iii) Chemotherapy is scheduled for the treatment of metastatic breast cancer.
- •(iv) A performance status of 0-1 according to the ECOG scale.
- •(v) Patients must have measurable disease or evaluable non-measurable disease.
- •(vi) All of the following conditions have to be met regarding organ function (within 14 days before registration).
- •(a) A neutrocyte count of 1,500/mm3 or higher
- •(b) A platelet count of 100,000/mm3 or higher.
- •(c) A hemoglobin count of 9.0 g/dL or higher
- •(d) Aspartate aminotransferase (AST, GOT) and alanine aminotransferase concentrations (ALT, GPT) of not more than 100 IU/L (When a patient has liver metastasis, this limitation sets it with 150 IU/L in particular )
- •(e) Total serum bilirubin of not more than 2.1 mg/dL
- •(f) A serum creatinine concentration of not more than 1.6 mg/dL. And creatinine clearance of 50 mL or higher, too
- •(vii) Hormone therapy,radiotherapy and chemotherapy: at least 14 days have elapsed. Surgery: at least 28 days have elapsed.
- •(viii) An age of 20-75 years.
- •(ix) Patient who can observe a treatment plan, periodical inspection, QoL evaluation and other procedures.
- •(x) Patient whom survival more than six months is expected of.
- •(xi) Written informed consent has been obtained directly from the subject
排除标准
- •(i) Overexpression of human epidermal growth factor receptor 2 (Her2), or the results of in situ hybridization are positive.
- •(ii) Patient has received more than two chemotherapy line for metastatic disease.
- •(iii)Patient has received eribulin or S-1.
- •(iv) Patient has more than CTCAE grade 3 anxiety at enrollment.
- •(v) The presence of interstitial pneumonia or pulmonary fibrosis.
- •(vi) The presence of cardiac conduction abnormality (heart failure, ischemic heart disease)
- •(vii) The presence of pleural effusion, ascites or pericardial effusion requiring tubing or emergency treatment.
- •(viii)Patient has to receive systemic steroid treatment continuously.
- •(xi) The presence of severe allergic reaction
- •(x) Women who are pregnant, breast feeding or intend to become pregnant.
- •(xi) The presence of uncontrollable brain metastasis or meningitis.
- •(xii)The presence of other active cancers (synchronous double cancers or metachronous double cancers with a disease-free interval of 5 years or less, excluded in situ lesion or mucosal lesion).
- •(xiii) bilateral breast cancer (excluded DCIS or corresponding ER and HER2 status)
研究者
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