JPRN-UMIN000023162已完成2 期
A multicenter randomized phase II clinical trial with neo -adjuvant chemotherapy containing eribulin mesylate for triple negative primary breast cancer patients (Neo-Entrance study) - A multicenter randomized phase II clinical trial with neo -adjuvant chemotherapy containing eribulin mesylate for triple negative primary breast cancer patients (Neo-Entrance study)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 70years-old（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •(1) Bilateral invasive breast cancer whether metachronous,concurrent or bilateral DCIS. Contralateral DCIS after mastectomy (Bt), skin-sparing mastectomy (SSM), nipple-sparing mastectomy (NSM), or equivalent are permitted. (2) Pt with multiple cancers other than breast cancer (3) Pt with axillary lymph node dissection before pre-operative chemotherapy (4) Pt with incisional or excisional biopsies for primary lesion or axillary lymph node (5) Participation in another clinical trial within 28 days after the second registration (6) Pt with peripheral neuropathy >= NCI CTCAE v.4.03 Grade 2 (7) Pt with cardiopulmonary dysfunctions within six months before the second registration (8) Pt with myocardial infarction within 12 months before the second registration (9) Pt with severe uncontrolled systemic diseases (10) Pt who undergone major surgery or serious trauma within 28 days before the second registration, or who will have a major surgery during this trial. (11) Pt with severe infectious disease requiring intravenous administration of antibiotics, antiviral agents, or anti-fungal agents at the second registration (12) Pt with dental caries and/or oral infections requiring treatment (13) Pt with diagnosed of active liver disease or sclerosing cholangitis caused by autoimmune liver disorders (14) Pt with HIV infection (15) Lactating Pt (16)Other diseases that are considered to affect consent acquisition or protocol compliance by an investigator or sub-investigator. (17) Pt with hypersensitive to the study drug or additives and with DPD deficiency (18) Pt with difficulty of the oral ingestion, dysfunction of the upper gastrointestinal tract and malabsorption syndrome ( only in case HRD negative or age>=65 years at consent acquisition) (19) Pt determined to be ineligible by an investigator.
研究者
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