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

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: Amgen; Genentech, Inc.
• Treatments: Albumin-Bound Paclitaxel; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Paclitaxel; Trastuzumab

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