An open-label, randomized, controlled Phase-II trial evaluating the efficacy and safety of EndoTAG-1 in triple receptor negative breast cancer patients
- Conditions
- Female patients with triple negative breast cancerMedDRA version: 8.1Level: LLTClassification code 10027475Term: Metastatic breast cancer
- Registration Number
- EUCTR2006-002221-23-DE
- Lead Sponsor
- MediGene AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 135
1. Histologically proven triple-receptor-negative metastatic or relapsed breast cancer
2. Minimum interval 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 greater or equal to 18 years old
6. Negative pregnancy test (females of childbearing potential)
7. Willingness to perform double-barrier-contraception during study and 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
1. More than 1 previous chemotherapeutic treatment for metastatic
or relapsed disease.
2. Major surgery < 4 weeks prior to enrollment
3. Immunotherapy <2 weeks prior to enrollment
4. Severe pulmonary obstructive or restrictive disease
5. Uncontrolled inflammatory disease (autoimmune or infectious)
6. Clinically significant cardiac disease (NYHA stadium > 2)
7. Laboratory tests (hematology, chemistry) outside specified limits:
WBC < or equal 3 x 10 EXP 9/L
ANC < or equal 1.5 x 10 EXP 9/L
Platelets < or equal 100 x 10 EXP 9/L
Hb < or equal 9.0 g/dl (< or equal 5.6 mmol/l)
PTT/INR > 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 and/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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 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.<br>
- Secondary Outcome Measures
Name Time Method