Trial document

drksid header


Trial Description

start of 1:1-Block title


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

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym


end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial


end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Women from high risk families with mutations in the BRCA1 or BRCA2 gene have a lifetime risk of about 60% for breast cancer and up to 40% for ovarian cancer. There is accumulating evidence from in vitro and retrospective in vivo studies that BRCA-associated breast cancer exhibit preferential treatment response to substances selectively targeting BRCA deficiency. E.g. the efficiency of platin compounds as cross-linkers is based on the induction of DNA double strand breaks (DSBs). The BRCA genes are involved in DSBs that lead to homologous recombination deficiency (HRD) in BRCA-deficient cells. Bifunctional alkylators (e.g. nitrosourea=carmustine/BCNU) have been recently discovered to show a stronger antitumoral activity compared to platin compounds in BRCA-associated carcinomas by creating cross-links. Therefore patients with advanced BRCA-associated breast and ovarian cancer will be treated with Carmustine.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Targeted chemotherapy with carmustine in patients with BRCA1- or BRCA2-associated advanced breast- and ovarian cancer which are refractory to standard therapy and for which no suitable, effective/curative therapy exists.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00004962
  •   2014/05/06
  •   [---]*
  •   yes
  •   Approved
  •   14-020, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2013-002036-24 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C50 -  Malignant neoplasm of breast
  •   C56 -  Malignant neoplasm of ovary
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Carmustine [Bis-Chlorethyl-Nitroso-Urea; BCNU], six 42 day-based courses of 90mg/m² (day 1, intermission of 42 days) , infusion
end of 1:N-Block interventions
start of 1:1-Block design


  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   IIa
  •   Yes
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Tumor response (i.e. non-progressive disease) after 3 cycles of chemotherapy / at week 18 (assessed using the principles of RECIST 1.1).

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Efficacy: tumor response after 6 cycles of chemotherapy /at week 36, OR (objective response), PFS (progression free survival), OS (overall survival), DOR (duration of response) and DCR (disease control rate), health-related quality of life (EORTC QLQ C30 and EQ-5D; after 3rd and 6th cycle), ECOG Performance Status

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment


  •   Planned
  •   2014/06/15
  •   10
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

•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 </=1.5 x institutional upper limit of normal (ULN); ASAT/ALT </= 2.5 x institutional ULN unless liver metastases are present in which case it must be </= 5 x ULN and renal function
•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

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

•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

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses


  • start of 1:1-Block address primary-sponsor
    • Universität zu Köln
    • Albertus Magnus Platz
    • 50923  Köln
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Zentrum für familiären Brust- und Eierstockkrebs Universitätsklinikum Köln
    • Ms.  PD Dr.  Kerstin  Rhiem 
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Zentrum Familiärer Brust- und Eierstockkrebs
    • Ms.  PD Dr. med.  Kerstin  Rhiem 
    • Kerpener Str. 34
    • 50931  Köln
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Medizinische Fakultät der Universität zu Köln, Forschungspool Klinische Studien
    • Kerpener Str. 62
    • 50937  Köln
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state


  •   Recruiting withdrawn before recruiting started
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.