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

niversität zu Köln0 个研究点目标入组 10 人开始时间: 2014年5月6日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•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
•ECOG 0-2 with adequate cardiac, bone marrow (platelet count >/= 100x109/l), hepatic (total bilirubin •Patients must have a life expectancy >/= 3 months
•-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
•In case of breast cancer, patients must have failed at least two previous lines of chemotherapy (not including hormonal treatment) in the metastatic/advanced setting. Patients with hormone receptor positive tumors must have also failed prior hormonal therapy. Patients who are Her2-positive must have failed prior trastuzumab and lapatinib.
•In case of ovarian cancer patients must have documented progressive or recurrent disease according to either RECIST or GCIG criteria either during or within six months from completion of most recent platinum-based chemotherapy, but not suitable for further platinum therapy.
•Advanced breast and ovarian cancer patients could have failed a therapy with PARP inhibitors.
•Age at least 18 years
•Not legally incapacitated
•Written informed consent from the trial subject has been obtained

•Prior chemotherapy with nitrosourea 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.
•Any psychological, sociological or geographical condition potentially impeding compliance with study protocol or follow-up
•Known or suspected allergy to the BCNU
•Persistent toxicities (>CTCAE grade 2) caused by previous therapies
•Participation in other interventional trials
•Pregnant women and nursing mothers

发起方

niversität zu Köln