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: 24 April 2012
• Main ID: EUCTR2006-002221-23-FR
• Date of registration: 23/02/2007
• 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: 06/07/2007
• Target sample size: 135
• Recruitment status: Authorised-recruitment may be ongoing or finished
• 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. 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

Exclusion criteria:
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



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-

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-

Primary Outcome(s)

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.

Secondary ID(s)

CT 4002

2006-002221-23-DE