A non-randomised, non-comparative monocenter investigator initiated trial to assess the efficacy and safety of Carmustine in patients with BRCA1/2-associated advanced breast and ovarian cancer - ADCARE

niversity of Cologne0 个研究点目标入组 0 人开始时间: 2014年1月30日最近更新: 2021年3月22日

适应症

试验速览

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•Female BRCA1 and BRCA2 mutation carriers
•Histological confirmed breast or ovarian cancer
•Refractory to standard therapies and for which no suitable effective standard therapy exists
•Age =18 years
•ECOG 0-2 with adequate cardiac, bone marrow (platelet count >/= 100x109/l), hepatic (total bilirubin •Patients must have a life expectancy >/= 3 months
•Postmenopausal or use of adequate contraceptive during chemotherapy and six months thereafter
•Fully informed consent prior to study-specific procedures
•Patient is willing and able to comply with the protocol for the duration of the study including treatment and scheduled visits and examinations
•At least one lesion (measurable and/or non-measurable) at baseline that can be accurately assessed by CT/MRI and is suitable for repeated assessment at follow-up visits
•All baseline radiological tumour assessments must be performed no earlier than 21 days before start of the study treatment.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 9
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 1

•Pregnant or nursing patients
•Prior chemotherapy with nitroso-urea substances for any malignancy
•Concurrent treatment with other experimental drugs or any other anti-cancer therapy
•Patients receiving any systemic chemotherapy, radiotherapy (except for palliative reasons) within 2 weeks from the last dose prior to study treatment.
•Nicotine abuse
•Limited pulmonary function
•Pre-existing pulmonary diseases (e.g. chronic obstructive pulmonary disease/COPD, fibrosis)
•Prior radiation including areas of the lung (except radiation of the breast after breast conserving surgery).
•Pre-existing radiographical alterations of the lung
•Any psychological, sociological or geographical condition potentially impeding compliance with study protocol or follow-up
•Known or suspected allergy to the BCNU
•Failure to use highly-effective contraceptive
•Persistent toxicities (>CTCAE grade 2) caused by previous therapies

发起方

niversity of Cologne