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 @ 2:12 PM
Ignite Modification Date:
2025-12-24 @ 2:12 PM
NCT ID:
NCT00082095
Eligibility Criteria:
Inclusion Criteria:
* Clinically or pathologically proven metastatic breast cancer
* Eastern Cooperative Oncology Group performance status between 0-2
* Adequate bone marrow, renal and liver functions within normal limits
* Left ventricular ejection fractions more than 45% measured by multiple gated acquisition scan or echocardiogram within 6 weeks of randomization
Exclusion Criteria:
* Prior chemotherapy for metastatic disease (hormonal or chemotherapy in adjuvant setting and hormonal therapy in metastatic setting is allowed)
* Prior treatment with capecitabine or pegylated liposomal doxorubicin in the adjuvant setting (prior anthracyclines up to certain dose limit is allowed)
* Evidence of brain metastases unless previously treated and asymptomatic for 3 months or greater
* History of cardiac disease with New York Heart Association Class II or greater or clinical evidence of congestive heart failure
* Anthracycline resistant disease (locally recurrent or metastatic disease while on adjuvant anthracycline therapy or relapse less than 18 months after therapy completion)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
60 Years
Study:
NCT00082095
Study Brief:
Protocol Section:
NCT00082095