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

• Register: EUCTR
• Last refreshed on: 4 March 2013
• Main ID: EUCTR2006-002221-23-DE
• Date of registration: 19/01/2007
• Prospective Registration: Yes
• Primary sponsor: MediGene AG
• Public title: An open-label, randomized, controlled Phase-II trial evaluating the efficacy and safety of EndoTAG-1 in triple receptor negative breast cancer patients
• Scientific title: An open-label, randomized, controlled Phase-II trial evaluating the efficacy and safety of EndoTAG-1 in triple receptor negative breast cancer patients
• Date of first enrolment: 05/03/2007
• Target sample size: 135
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-002221-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

France, Germany

Key inclusion & exclusion criteria

Inclusion criteria:
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

Exclusion criteria:
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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Female patients with triple negative breast cancer
MedDRA version: 8.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer

Intervention(s)

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-

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-

Primary Outcome(s)

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.

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.

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 ID(s)

CT 4002