High-dose alkylating chemotherapy in oligo-metastatic breast cancer harboring homologous recombination deficiency - OLIGO study

KI-AV0 个研究点目标入组 74 人开始时间: 2012年5月9日最近更新: 2019年12月16日

适应症

试验速览

暂无简介。

•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.
•No prior line of chemotherapy for metastatic disease (a maximum of 3 months of palliative endocrine therapy is allowed).
•The tumor must be HER2-negative
•The tumor is deficient in homologous recombination and/or the patient has a deleterious germline BRCA1 or BRCA2 • 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)
•If clinically recommended LVEF =50% measured by echocardiography or MUGA
•Signed written informed consent
•Able to comply with the protocol
•Are the trial subjects under 18? no
•Number of subjects for this age range: 100
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 74
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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. No second breast tumor.
•Current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection.
•Concurrent anti-cancer treatment or investigational drugs

发起方

KI-AV