NL-OMON50592招募中3 期
High-dose alkylating chemotherapy in oligo-metastatic breast cancer harboring homologous recombination deficiency - OLIGO study
ederlands Kanker Instituut0 个研究点目标入组 74 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 74
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.
- •The tumor must be HER2-negative
- •The tumor is deficient in homologous recombination and/or the patient has a
- •deleterious germline BRCA1 or BRCA2 mutation
- •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
- •Adequate renal function (creatinine clearance >=60 ml/min)
- •if clinically recommended LVEF >=50% measured by echocardiography or MUGA
- •Signed written informed consent
- •Able to comply with the protocol
排除标准
- •No prior line of chemotherapy for metastatic disease (a maximum of 3 months
- •of palliative endocrine therapy is allowed).
- •Malignancy other than breast cancer, unless treated with curative intent and
- •associated with long-term-survival probability >95%,including but not limited
- •to basal cell carcinoma and papillary/follicular thyroid carcinoma.
- •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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