JPRN-jRCTs031180151进行中（未招募）3 期
JCOG1017: A randomized controlled trial comparing primary tumor resection plus systemic therapy with systemic therapy alone in metastatic breast cancer - PRIM-BC
IWATA Hiroji0 个研究点目标入组 600 人开始时间: 2019年2月25日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
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
- >= 20age old 至 <= 80age old（—）
- 性别
- Female
入选标准
- •First registration
- •1. Histologically proven breast cancer confirmed by biopsy from the tumor.
- •2. Presense/absence of overexpression of estrogen receptor (ER) and HER2 was examined by IHC or FISH or DISH analyses.
- •3. Neither bilateral breast cancer nor invasion to contralateral breast.
- •4. At least one measurable lesion other than the breast tumor and ipsilateral axillary lymph nodes was detected by CT or MRI before primary registration.
- •5. No brain metastasis.
- •6. Women aged 20 to 80 years old.
- •7. ECOG performance status (PS) of 0 or 1. PS of 2 caused by the symptom from bone metastasis is also eligible.
- •8. No prior surgery, chemotherapy or radiotherapy for any other malignancies within 5 years.
- •9. No history of invasive breast cancer. Non-invasive breast cancer resected completely by partial mastectomy is eligible.
- •10. Neither prior chemotherapy for breast cancer nor prior radiotherapy for ipsilateral breast (radiotherapy for bone metastasis within 30Gy and 10 times before registration is allowed).
- •11. Sufficient organ functions.
- •12. Witten informed consent.
- •Second registration (after primary chemotherapy)
- •1. Primary chemotherapy was performed after the first registration and protocol treatment is not discontinued.
- •2. Objective response of primary chemotherapy was neither PD nor NE.
- •3. Within 28 days from the date of response evaluation.
- •4. Sufficient organ functions.
- •5. Complete resection is expected to be possible by total or patial mastectomy without resection of adjacent organs and/or wide skin transplant.
- •6. No active bleeding from breast tumor which necessitates blood transfusion within 28 days before second regstration.
排除标准
- •First registration (no exclusion criteria at second registration)
- •1. Simultaneous or metachronous (within 5 years) double cancers.
- •2. Infectius disease to be treated.
- •3. Body temperature of 38C or higher.
- •4. Women during pregnancy or breast-feeding.
- •5. Psychiatric diseases.
- •6. Systemic and continuous steroids medication.
- •7. Comorbid unstable angina pectoris or history of myocardial infarction within 6 months.
- •8. Uncotrollable hypertension.
- •9. Diabetes mellitus uncontrollable or treated by continuous insulin administration .
研究者
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