Клинические исследования в Украине

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Краткое названиеEndoTAG-1 in Triple Receptor Negative Breast Cancer Patients
Полное названиеAn Open-label, Randomized, Controlled Phase-II Trial Evaluating the Efficacy and Safety of EndoTAG-1 in Triple Receptor Negative Breast Cancer Patients
Под контролемBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Краткое описаниеThe purpose of this study is to assess the efficacy, safety and tolerability of a therapy
with EndoTAG-1 + paclitaxel in combination and EndoTAG-1 alone as a rescue therapy for
patients with relapsed or metastatic triple receptor negative breast cancer (a special
subgroup of breast cancer).
СостояниеАктивный, набор окончен
Дата началаJanuary 2007
ФазаPhase 2
Подробное описаниеBreast 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)
Вид исследованияAllocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
КритерииInclusion 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
Минимальный возраст18 Years
Максимальный возрастN/A
УсловиеBreast Neoplasms
Применяемое лечение
DrugEndoTAG-1 + paclitaxel
Контакты и расположение
Dnepropetrovsk Dnepropetrovsk State Medical Acedamy
Kharkov Institute of Medical Radiology of Acedamy of Medical Sciences
Kiev Department of Abdominal Surgery
Kiev Institut of Oncology
Kiev Surgical Department
Rovno Rivne Regional Oncological Dispensary
Sumy Sumy Reginal Oncology Center
Uzhorod Regional Clinical Oncological Dispensary
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