Phase 2 N=70 Treatment

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

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00591851 ↗

Enrolled (actual)

Serious AEs

27.1%

Results posted

Dec 2014

Primary outcome: Primary: Cardiac Saftey — 68; 67; 66; 65 percentage of LVEF

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: AC [Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)] Followed By Paclitaxel (P) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Memorial Sloan Kettering Cancer Center
Primary completion: Jun 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Cardiac Saftey	68; 67; 66; 65; 66	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00591851). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.