Expired Study
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New York, New York 10065


Purpose:

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.


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


NCT ID:

NCT00591851


Primary Contact:

Principal Investigator
Chau Dang, MD
Memorial Sloan-Kettering Cancer Center


Backup Contact:

N/A


Location Contact:

New York, New York 10065
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 19, 2018

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