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 @ 7:15 PM
Ignite Modification Date:
2025-12-24 @ 7:15 PM
NCT ID:
NCT01095003
Eligibility Criteria:
Inclusion Criteria:
* female patients
* 21 years of age or older
* histologically/cytologically confirmed carcinoma of the breast
* documented locally recurrent or metastatic disease not amenable to curative surgery or radiotherapy
* either one, two or three prior chemotherapy regimens
* prior treatments including both an anthracycline and a taxane and patient no longer candidate for these drugs
* measurable or non-measurable disease according to RECIST 1.1
* Karnofsky performance score of at least 70 %
* adequate haematological, hepatic and renal functions
* ECG without clinically relevant abnormality
Exclusion Criteria:
* known or clinical evidence of brain metastasis or leptomeningeal involvement
* pulmonary lymphangitis or symptomatic pleural effusion
* any serious, concurrent uncontrolled medical disorder
* history of second primary malignancy
* preexisting motor/sensory peripheral neuropathy
* known history of HIV infection
* prior therapy with capecitabine and/or vinca-alkaloids
* history of severe hypersensitivity to vinca alkaloids and/or to fluoropyrimidine or contra indication to any of these drugs
* known or suspected dihydropyrimidine dehydrogenase (DPD) deficiency
* pregnancy or breast feeding
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Study:
NCT01095003
Study Brief:
Protocol Section:
NCT01095003