Treatment of advanced breast- and ovarian cancer which are refractory to standard therapy and for which no suitable, effective/curative therapy exists.

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002036-24-DE

Enrollment

Registered

2014-01-30

Start date

2014-06-24

Completion date

Unknown

Last updated

2021-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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. MedDRA version: 17.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Carmubris Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: CARMUSTINE CAS Number: 154-93-8 Concentration unit: mg/m2 milligram(s)/square meter Concen

Eligibility

Sex/Gender

All

Inclusion criteria

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 • Age =18 years • ECOG 0-2 with adequate cardiac, bone marrow (platelet count >/= 100x109/l), hepatic (total bilirubin /= 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

Exclusion criteria

Exclusion criteria: • 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

Design outcomes

Primary

Measure	Time frame
Main Objective: Tumor response (i.e. non-progressive disease) after 2 and 4 cycles of chemotherapy / at week 12 and 24 (assessed using the principles of RECIST 1.1, based on confirmed response);Secondary Objective: Tumor response (OR) after 6 cycles of chemotherapy /at week 36, PFS, OS, DOR and DCR, health-related quality of life (EORTC QLQ C30 and EQ-5D), ECOG Performance Status;Primary end point(s): Tumor response (i.e. non-progressive disease) after 2 and 4 cycles of chemotherapy / at week 12 and 24 (assessed using the principles of RECIST 1.1, based on confirmed response);Timepoint(s) of evaluation of this end point: After 12 and 24 weeks (2 and 4 cycles) of chemotherapy	—

Measure

Time frame

Main Objective: Tumor response (i.e. non-progressive disease) after 2 and 4 cycles of chemotherapy / at week 12 and 24 (assessed using the principles of RECIST 1.1, based on confirmed response);Secondary Objective: Tumor response (OR) after 6 cycles of chemotherapy /at week 36, PFS, OS, DOR and DCR, health-related quality of life (EORTC QLQ C30 and EQ-5D), ECOG Performance Status;Primary end point(s): Tumor response (i.e. non-progressive disease) after 2 and 4 cycles of chemotherapy / at week 12 and 24 (assessed using the principles of RECIST 1.1, based on confirmed response);Timepoint(s) of evaluation of this end point: After 12 and 24 weeks (2 and 4 cycles) of chemotherapy

—

Secondary

Measure	Time frame
Secondary end point(s): Secondary objective is the efficacy of the treatment measured by tumor response after 6 cycles of chemotherapy /at week 36 (assessed by OR, PFS, OS, DOR and DCR, health-related quality of life (EORTC QLQ C30 and EQ-5D), ECOG Performance Status). ;Timepoint(s) of evaluation of this end point: After 36 weeks (6 cycles) of chemotherapy	—

Countries

Germany

Contacts

Public ContactAdCare

Center of Familial Breast and Ovarian Cancer

+4922147886509

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026