EndoTAG-1 in Triple Receptor Negative Breast Cancer Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00448305
• Date of registration: 15/03/2007
• Prospective Registration: No
• Primary sponsor: MediGene
• Public title: 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: January 2007
• Target sample size: 143
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00448305
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Belgium, France, Germany, India, Poland, Romania, Ukraine

Contacts

• Name: Ahmad Awada, Dr.
• Affiliation: Institut Jules Bordet - Centre des Tumeurs de l'Université Libre de Bruxelles, 121 Boulevard de Waterloo, 1000 Brussels, Belgium

Key inclusion & exclusion criteria

Inclusion Criteria:

- Histologically proven triple-receptor-negative metastatic or relapsed breast cancer

- Minimum interval of 6 months after the end of any previous taxane- containing
chemotherapy regimen

- At least one tumor lesion measurable according to RECIST criteria

- Gender: female

- Age >= 18 years old

- Negative pregnancy test (females of childbearing potential)

- Willingness to perform double-barrier-contraception during study and for 6 months
post chemotherapy treatment

- ECOG performance status 0, 1 or 2

- Signed informed consent

Exclusion Criteria:

- More than 1 previous chemotherapeutic treatment for metastatic or relapsed disease

- Major surgery < 4 weeks prior to enrollment

- Immunotherapy < 2 weeks prior to enrollment

- Severe pulmonary obstructive or restrictive disease

- Uncontrolled inflammatory disease (autoimmune or infectious)

- Clinically significant cardiac disease (NYHA stadium > 2)

- Laboratory tests (hematology, chemistry) outside specified limits

- Pregnancy or nursing status

- Known positive HIV testing

- Known hypersensitivity to any component of the EndoTAG-1 or taxane formulations

- History of malignancy other than breast cancer < 5 years prior to enrollment, except
skin cancer (i.e. basal or squamous cell carcinoma) treated locally

- 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)

- History of active or significant neurological disorder 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

- 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: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Neoplasms

Intervention(s)

Drug: EndoTAG-1

Drug: EndoTAG-1 + paclitaxel

Drug: Paclitaxel

Primary Outcome(s)

4-month progression free survival (PFS) rate [Time Frame: 4 month]

Secondary Outcome(s)

adverse events [Time Frame: Last patient out]

4-month survival rate [Time Frame: 4-month]

tumor response [Time Frame: Last patient out]

pain assessment [Time Frame: Last patient out]

median progression free survival (PFS) time [Time Frame: progression of last patient]

laboratory values [Time Frame: Last patient out]

clinical benefit assessment via quality of life (QoL)Scale [Time Frame: Last patient out]

median overall survival time [Time Frame: Withdrawal or death of last patient]

dose variations [Time Frame: Last patient out]

Secondary ID(s)

CT 4002

EudraCT-Nr. 2006-002221-23

Source(s) of Monetary Support

Please refer to primary and secondary sponsors