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 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT00591851
Eligibility Criteria:
Inclusion Criteria:
* adenocarcinoma breast cancer
* ECOG performance status of 0 or 1
* peripheral neuropathy less than or equal to 1
* discontinued hormonal therapy as a chemoprevention while onstudy
* LVEF by MUGA \> 55%?
* Absolute neutrophil count (ANC)\> 1000/µL)
* platelet count \> 100,000/µL)
* SGOT OR SGPT \< 92.5 units/L
Exclusion Criteria:
* Stage IV breast cancer
* any chemotherapy, radiation therapy, immunotherapy, or biotherapy for a CURRENT breast cancer
* pregnant or lactating patients
* active second malignancy, other than adequately treated non-melanoma skin cancers or in situ cervical cancer
* previous allergy/hypersensitivity to Doxorubicin, Cyclophosphamide, Paclitaxel, or other drugs formulated in Cremophor EL?
* unstable angina, congestive heart failure, current use of digitalis, beta-blockers, or calcium blockers for therapy of congestive heart failure, arrhythmia requiring medical therapy, or a history of a myocardial infarction within 12 months
* psychiatric illness that prevents her from understanding the nature of this study and complying with protocol requirements?
* active, unresolved infections
* sensitivity to E. coli derived proteins
* prior chemotherapy with an anthracycline
* prior Herceptin therapy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT00591851
Study Brief:
Protocol Section:
NCT00591851