An open-label, randomized, controlled Phase-II trial evaluating the efficacy and safety of EndoTAG-1 in triple receptor negative breast cancer patients

INTERVENTION: Product Name: EndoTAG‐1 (lipid complexed paclitaxel) Product Code: MDG 09.101 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: Paclitaxel Current Sponsor code: MDG 09.100 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 6.40‐ Trade Name: Taxol Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Paclitaxel CAS Number: 33069‐62‐4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6‐ CONDITION: Female patients with triple negative breast cancer ; MedDRA version: 8.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer PRIMARY OUTCOME: 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 breast cancer after adjuvant or neoadjuvant treament with anthracycline +/‐ taxane; 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.; 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. INCLUSION CRITERIA: 1. Histologically proven triple‐receptor‐negative metastatic or relapsed breast cancer 2. Patients must have received adjuvant or neoadjuvant chemotherapy containing an anthracycline regimen alone or in combination with a taxane containing regimen, i.e. a R0 resection status must have been achieved after initial diagnosis 3. Minimum interval after the end of adjuvant or neoadjuvant chemotherapy anthracycline regimen alone = no chemotherapy free interval needed taxane containing regimen = 6 months after end of chemotherapy 4. Tumor lesions measurable according to RECIST criteria 5. Gender: female 6. Age greater or equal to 18 years old 7. Negative pregnancy test (females of childbearing potential) 8. Willingness to perform double‐barrier‐contraception during study and for 6 months post chemotherapy treatment 9. ECOG performance status 0, 1 or 2 10. N