Patients with triple negative breast cancer MedDRA version: 8.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer
Conditions
Interventions
Product Name: EndoTAG-1 (Liposomal paclitaxel)
Product Code: MDG 09.101
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Paclitaxel
Current Sponsor code: MDG 09.100
Concentr
Sponsors
MediGene AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically proven triple-receptor-negative metastatic or relapsed breast cancer 2. Minimum interval of 6 months after the end of any previous taxane-containing chemotherapy regimen 3. At least one tumor lesion measurable according to RECIST criteria 4. Gender: female 5. Age equal or mayor 18 years old 6. Negative pregnancy test (females of childbearing potential) 7. Willingness to perform double-barrier-contraception during studyand for 6 months post chemotherapy treatment 8. ECOG performance status 0, 1 or 2 9. Signed informed consent 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. More than 1 previous chemotherapeutic treatment for metastatic or relapsed disease 2. Major surgery 2) 7. Laboratory tests (hematology, chemistry) outside specified limits: • WBC 1.5 x ULN • AST or ALT > 2.5 x ULN • Alkaline Phosphatase > 2 x ULN • Total Bilirubin > 1.5 x ULN 8. Pregnancy or nursing status 9. Known positive HIV testing 10. Known hypersensitivity to any component of the EndoTAG-1 or taxane formulations 11. History of malignancy other than breast cancer < 5 years prior to enrollment, except skin cancer (i.e. basal or squamous cell carcinoma) treated locally 12. Known progressive cerebral metastasis (patients with cerebral metastases in a stable state or after successful surgical or radiological treatment are allowed to participate in the study) 13. History of active or significant neurological disorder or psychiatric disorder that would prohibit the understanding and giving of informed consent, or would interfere in the clinical and radiological evaluation of central nervous system during the trial 14. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective is to assess the efficacy of EndoTAG-1 + paclitaxel (combination therapy) and EndoTAG-1 (monotherapy) as a rescue therapy for patients with triple receptor negative relapsed and/or metastatic breast cancer.;Secondary Objective: Secondary objective is to assess the safety and tolerability of EndoTAG-1 + paclitaxel (combination therapy) and EndoTAG-1 (monotherapy) in this patient population.;Primary end point(s): Primary efficacy endpoint is: 4-month progression free survival (PFS) rate calculated by the rate of patients in the modified intention-to-treat population (mITT) who show no progression of disease and are alive 16 weeks after first infusion of study drug. | — |
Countries
Belgium, France, Germany
Outcome results
None listed