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:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-24 @ 5:36 PM
NCT ID:
NCT01091168
Eligibility Criteria:
Inclusion Criteria:(main conditions)
* Female patients 18 to 75 years of age with metastatic breast cancer histologically/cytologically confirmed not amenable to curative surgery or radiotherapy and who have received at least two prior chemotherapy regimens including anthracyclines,taxanes,antimetabolite and vinca-alkaloid and are no longer candidate for these drugs,
* Karnofsky performance score of at least 70 %, adequate haematological, hepatic and renal functions and ECG without clinically relevant abnormality.
Exclusion Criteria:
* Concurrent serious uncontrolled medical disorder,
* known or clinical evidence of brain metastases or leptomeningeal involvement,
* pulmonary lymphangitis or symptomatic pleural effusion or symptomatic ascites,
* history of second primary malignancy,
* HIV infection, preexisting neuropathy,
* pregnancy or breast feeding.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01091168
Study Brief:
Protocol Section:
NCT01091168