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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00591851
• Other study ID #: 04-126
• Status: Completed
• Phase: Phase 2
• Start date: December 2004
• Est. completion date: June 2008

Study information

• Verified date: September 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Amgen, Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Saftey	LVEF by Muga scan	Baseline-18 months