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 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT00964704
Eligibility Criteria:
Inclusion Criteria:
* male or female patients, age \>/=18 years
* locally recurrent or metastatic HER2-positive breast cancer
* disease progression during or up to 12 months after prior adjuvant therapy with trastuzumab
* LVEF \>/=55% at baseline
Exclusion Criteria:
* prior treatment with bevacizumab or capecitabine
* anthracyclines in prior adjuvant or neoadjuvant treatment exceeding cumulative dose of 360mg/m2 for doxorubicin and 720mg/kg for epirubicin
* chronic daily treatment with corticosteroids (\>10mg/day methylprednisolone equivalent; excluding inhaled corticosteroids), or aspirin (\>325mg/day), or clopidogrel (\>75mg/day)
* clinically significant cardiac disease, or cardiac toxicity during previous trastuzumab therapy
* evidence of spinal cord compression or CNS metastasis
* history of other malignancy, unless disease-free for \>/=5 years or treated curatively for carcinoma in situ of the cervix or non-melanomatous skin cancer
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00964704
Study Brief:
Protocol Section:
NCT00964704