Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT00448305
Eligibility 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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00448305
Study Brief:
Protocol Section:
NCT00448305