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

Phase 2

Completed

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

• Registration Number: NCT00591851
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2008-01-10
• Study First Posted: 2008-01-11
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Results First Submitted: 2014-11-24
• Results First Submitted QC: 2014-11-24
• Results First Posted: 2014-12-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-11
• Last Update Posted: 2023-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	AC [Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)] Followed By Paclitaxel (P)	single arm study

Primary Outcome Measures

Name	Time	Method
Cardiac Saftey	Baseline-18 months	LVEF by Muga scan

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States