Clinical trial NCT00591851: Phase II Study of Dose-Dense Doxurubicin and Cyclophosphamide (AC) Followed By Paclitaxel With Trastuzumab in HER2/ NEU-Amplified Breast Cancer: Feasibility
Official title: Phase II Study of Dose-Dense Doxurubicin and Cyclophosphamide (AC) Followed By Paclitaxel With Trastuzumab in HER2/ NEU-Amplified Breast Cancer: Feasibility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast cancer
adenocarcinoma of the breast
cardiac safety
Breast cancer patients seen at the Memorial Sloan-Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Amgen
name: Genentech, Inc.
First posted: 2008-01-11
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Cardiac Saftey
timeFrame: Baseline-18 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Chau Dang, MD
role: PRINCIPAL_INVESTIGATOR
References: