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 @ 1:44 AM
Ignite Modification Date:
2025-12-25 @ 1:44 AM
NCT ID:
NCT00159094
Eligibility Criteria:
Inclusion Criteria:
* Patients must be informed of the investigational nature of this study and must give and sign informed consent in compliance with federal and institutional guidelines.
* Women 18 years or older with biopsy proven advanced breast cancer.
* Patients with reproductive potential must use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide, or surgical sterilization) during treatment and for three months after completing treatment.
* Performance status (PS) 0-2 (ECOG). PS must be 0-1 if patient has had more than one prior regimen for metastatic disease or more than 2 prior regimens, including adjuvant and metastatic.
* Measurable disease by RECIST criteria, with baseline staging completed within 14 days of registration.
* At least two weeks post surgery and three weeks from completion of irradiation and recovered from toxicities associated with these treatments.
* Psychological, family, social and geographical conditions allowing weekly medical follow up during chemotherapy are required.
* Preregistration blood work must include complete blood counts with differential, and blood chemistries including serum bilirubin, GGT, LDH, SGOT, SGPT, alkaline phosphatase, creatinine, and tumor markers, CEA and CA 27-29. Patients must have:
* Absolute neutrophil count (ANC) \>1,500/mm3
* Platelet count \>100,000/mm3
* Hemoglobin \> 8.0 g/dl
* Serum creatinine \< 2.5 mg/dl (\< 200 mol/L)
* Serum bilirubin \< the upper limit of normal (ULN)
* SGOT and SGPT or AST and ALT \< 2.0 x ULN
* Alkaline phosphatase \< 2.0 x ULN, except if attributed to tumor
* Life expectancy \> than 12 week.
Exclusion Criteria:
* Prior Doxil® or vinorelbine
* Cumulative anthracycline dose exceeding 400 mg/m2 anthracycline
* Primary anthracycline refractory disease, ie. disease progression during treatment or relapse/recurrence within 6 months after last dose of anthracycline
* If PS 0-1, more than 3 prior chemotherapy regimens, including adjuvant and metastatic
* If PS 2, more than 1 prior regimen for metastatic disease or more than 2 prior chemotherapy regimens, including adjuvant and metastatic
* Hormone therapy including aromatase inhibitors within 2 weeks of baseline
* Pregnant or lactating women. Women of reproductive potential must have a negative pregnancy test and must agree to use an effective contraceptive method
* Prior history of cardiac disease, with New York Heart Association Class II or greater, or clinical evidence of congestive heart failure
* Symptomatic brain metastasis
* Past medical history of severe hypersensitivity reaction to conventional formulation of doxorubicin HCL or the components of Doxil® or vinorelbine
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00159094
Study Brief:
Protocol Section:
NCT00159094