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-FR
- Lead Sponsor
- MediGene AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 135
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. Normal cardiac function (i.e. normal ECG, echocardiography or left ventricular ejection fraction and clinical examination)
11. 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. Chemotherapeutic treatment for relapsed/metastatic breast cancer before enrollment
2. Any radiotherapy for metastatic breast cancer before enrollment except for treatment of bone metastases or local recurrences if target lesions are not included in the irradiated field
3. Major surgery < 4 weeks prior to enrollment
4. Surgery of relapse resulting in a R0 resection status
5. Immunotherapy < 6 weeks prior to enrollment
6. Severe pulmonary obstructive or restrictive disease
7. Acute or chronic inflammation (autoimmune or infectious)
8. 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)
PT/PTT > 1.5 x ULN
9. Pregnancy or nursing status
10. Positive HIV testing
11. Known hypersensitivity to any component of the EndoTAG-1 and/or taxane formulations
12. History of malignancy other than breast cancer < 5 years prior to enrollment, except skin cancer (i.e. basal or squamous cell carcinoma) treated locally
13. Known cerebral metastasis
14. 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
15. 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 breast cancer after adjuvant or neoadjuvant treament with anthracycline +/- taxane<br>;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