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An Open-label, Randomized, Controlled Phase-II Trial Evaluating the Efficacy and Safety of EndoTAG-1 in Triple Receptor Negative Breast Cancer Patients

Phase 2
18 Years
Not Enrolling
Breast Neoplasms

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Trial Information

An Open-label, Randomized, Controlled Phase-II Trial Evaluating the Efficacy and Safety of EndoTAG-1 in Triple Receptor Negative Breast Cancer Patients

Breast cancer is still a major public health problem worldwide, as it is by far the most
frequent neoplasm in women. In recent years so-called "profiling of breast cancer" with
expression arrays has become common and it was suggested that the results will allow
individualization of care. Breast cancer may now be subclassified into luminal, basal, and
HER-2 subtypes with distinct differences in prognosis and response to therapy. About 80% of
all basal-like-breast cancers possess a so-called "triple-receptor-negative" phenotype.

Patients with "triple receptor negative breast cancer" have a complete absence of hormone
receptors incl. HER-2, an aggressive clinical course and a paucity of treatment options. The
only therapeutic option is chemotherapy and in this respect the choice of cytostatic agents
is limited. Against this background, the study tries to find another therapeutic option by
combining a vascular-disrupting activity with the cytostatic effects of paclitaxel in the
study drug EndoTAG-1.

Comparison: EndoTAG-1 + paclitaxel (combination therapy) and EndoTAG-1 (monotherapy) in
comparison to paclitaxel (control group)

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

- Concurrent treatment with other experimental drugs. Participation in another clinical
trial with any investigational not marketed drug within 30 days prior to study entry

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

4-month progression free survival (PFS) rate

Outcome Time Frame:

4 month

Safety Issue:


Principal Investigator

Ahmad Awada, Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Jules Bordet - Centre des Tumeurs de l'Université Libre de Bruxelles, 121 Boulevard de Waterloo, 1000 Brussels, Belgium


Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

Study ID:

CT 4002



Start Date:

January 2007

Completion Date:

March 2011

Related Keywords:

  • Breast Neoplasms
  • breast cancer
  • metastatic
  • relapsed
  • triple-receptor negative
  • EndoTAG-1
  • metastatic or relapsed breast neoplasm
  • Breast Neoplasms
  • Neoplasms