JPRN-jRCTs051180057已完成3 期
Postoperative Therapy with S-1 for Estrogen Receptor-positive, HER2-negative Breast CancerPhase III Randomized Comparison Study - POTENT
Toi Masakazu0 个研究点目标入组 1,959 人开始时间: 2019年2月13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
- 1,959
研究概览
简要总结
While serious AEs occurred significantly more often in the S-1 group compared with the control group and thus safety profile deserves sufficient consideration, this study has proven that the concurrent administration of standard postoperative endocrine therapy with S-1 increases the recurrence-inhibitory effect compared with standard postoperative endocrine therapy alone in patients with ER-positive and HER2-negative primary breast cancer.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 75age old（—）
- 性别
- Female
入选标准
- •[Target disease]
- •Estrogen receptor-positive, HER2-negative primary breast cancer
- •[Inclusion criteria]
- •1) Females histologically diagnosed with invasive breast cancer
- •2) Stage I to Stage IIIA at first diagnosis and Stage IIIB with a radical operation performed
- •3) ER-positive
- •4) HER2-negative
- •5) The risk of recurrence is intermediate or higher
- •6) A test performed within 14 days before registration shows the conservation of the major organ functions
- •7) Written consent has been obtained from the patient
排除标准
- •[Exclusion criteria]
- •1) Active double cancer
- •2) Bilateral (synchronous/dyschronous) breast cancer and inflammatory breast cancer
- •3) More than 2 weeks of prior treatment with oral 5-FU (patients with a history of prior treatment with intravenous 5-FU are eligible for registration)
- •4) Serious diarrhea
- •5) Serious complications
- •6) Past medical history such as myocardial infarction, interstitial pneumonia, or allergy to fluorinated pyrimidines
- •7) Pregnant women, lactating women, or women desiring pregnancy
- •8) Patients judged by the physician to be inappropriate for registration in the study
研究者
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