NL-OMON36155撤回2 期
High-dose alkylating chemotherapy in oligo-metastatic breast cancer harboring homologous recombination deficiency - the OLIGO study
ederlands Kanker Instituut0 个研究点目标入组 100 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 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
- 18 至 99（—）
入选标准
- •- Histologically or cytologically confirmed infiltrating breast cancer
- •- Oligometastatic disease defined as one to three metastatic lesions, with or without primary tumor, local recurrence, or locoregional lymph node metastases, including the axillary, parasternal, and ipsilateral periclavicular regions. All lesions must be amenable to resection or radiotherapy with curative intent. Staging examinations must have included a PET-scan plus diagnostic CT-scan of the chest and abdomen, and an isotope bone scan. When the isotope bone scan is doubtful and plain radiographs do not explain the abnormality, MRI or CT-scan of the affected skeletal region must be performed.
- •- The tumor must be HER2-negative (either score 0 or 1 at immunohistochemistry or negative at in situ hybridization [CISH or FISH] in case of score 2 or 3 at immunohistochemistry).
- •- The tumor must be ER and PgR negative (<10% nuclear staining at IHC) unless the patient is a known BRCA1 or BRCA2 mutation carrier. The rare tumors that are ER-negative and PgR-positive will be eligible, if this pattern of hormone receptor expression can be verified in the NKI-AVL reference pathology lab.
- •- Age *18 years
- •- World Health Organisation (WHO) performance status 0 or 1
- •- Adequate bone marrow function (ANC *1.0 x 109/l, platelets *100 x 109/l)
- •- Adequate hepatic function (ALAT, ASAT and bilirubin *2.5 times upper limit of normal)
- •- Adequate renal function (creatinine clearance *60 ml/min)
- •- LVEF *50% measured by echocardiography or MUGA
- •- Absence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •- Signed written informed consent
- •- Able to comply with the protocol
排除标准
- •- Malignancy other than breast cancer, unless treated with curative intent without the use of chemotherapy or radiation therapy
- •- Current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection.
- •- Concurrent anti-cancer treatment or investigational drugs
研究者
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