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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AC [Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)] Followed By Paclitaxel (P)

Drug

AC [Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)] Followed By Paclitaxel (P)

Primary outcomes

Cardiac Saftey

Time frame: Baseline-18 months

LVEF by Muga scan

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

Amgen
Genentech, Inc.

Registry information

Important dates

Study start: 2004
Primary completion: 2008
Study completion: 2008
First posted: Jan 11, 2008
Registry last updated: Sep 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed