Phase II Study of Dose-Dense Doxurubicin and Cyclophosphamide (AC) Followed By Paclitaxel With Trastuzumab in HER2/ NEU-Amplified Breast Cancer: Feasibility
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