HER-2/neu (+) breast cancer is a more aggressive form of breast cancer. HER-2/neu is a
protein that is overproduced by your tumor. It makes your cancer more aggressive. Standard
treatments for this type of cancer will help some people, but there is a moderate to high
chance that your cancer may come back.
The purpose of this study is to see if a new regimen will be effective in preventing cancer
from coming back. This is a phase II trial. In this trial, patient get a drug regimen that
has been tested in small groups of people to see what dose is safe. Researchers now wish to
see how effective the drug is for HER-2/neu (+) breast cancer. The objective includes
looking at short-term side effects and risks of the drug. All of the drugs on this regimen
can affect the heart which can be a serious side effect. The drugs affect on heart function
is a primary focus.
- 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
- Stage IV breast cancer
- any chemotherapy, radiation therapy, immunotherapy, or biotherapy for a CURRENT
- 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