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

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center Amgen Genentech
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00591851

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.

Condition	Intervention	Phase
Breast Cancer	Drug: AC [Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)] Followed By Paclitaxel (P)	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Paclitaxel Trastuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Study of Dose-Dense Doxurubicin and Cyclophosphamide (AC) Followed By Paclitaxel With Trastuzumab in HER2/ NEU-Amplified Breast Cancer: Feasibility

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Enrollment:	70
Study Start Date:	December 2004
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention single arm study	Drug: AC [Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)] Followed By Paclitaxel (P) No Intervention

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Chau Dang, MD )
Study ID Numbers:	04-126
Study First Received:	December 26, 2007
Last Updated:	July 3, 2008
ClinicalTrials.gov Identifier:	NCT00591851
Health Authority:	United States: Food and Drug Administration

Keywords provided by Memorial Sloan-Kettering Cancer Center:

breast cancer
adenocarcinoma of the breast
cardiac safety
Breast cancer patients seen at the Memorial Sloan-Kettering Cancer Center

Study placed in the following topic categories:

Skin Diseases
Paclitaxel
Trastuzumab
Breast Neoplasms

Cyclophosphamide
Adenocarcinoma
Doxorubicin
Breast Diseases

Additional relevant MeSH terms:

Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Mitosis Modulators
Physiological Effects of Drugs
Antimitotic Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms

Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Antineoplastic Agents, Phytogenic
Alkylating Agents

ClinicalTrials.gov processed this record on January 16, 2009