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

Study Overview
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Brief Summary
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: AC [Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)] Followed By Paclitaxel (P)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>single arm study | Drug: AC [Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)] Followed By Paclitaxel (P)<br>* AC [Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)] Followed By Paclitaxel (P)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac Saftey | LVEF by Muga scan | Baseline-18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, adenocarcinoma of the breast, cardiac safety, Breast cancer patients seen at the Memorial Sloan-Kettering Cancer Center