Phase 2
Completed N=70
Phase II Study of Dose-Dense Doxurubicin and Cyclophosphamide (AC) Followed By Paclitaxel With Trastuzumab in HER2/ NEU-Amplified Breast Cancer: Feasibility
Source: ClinicalTrials.gov NCT00591851 ↗Enrolled (actual)
70
Serious AEs
27.1%
Results posted
Dec 2014
Primary outcomePrimary: Cardiac Saftey — 68; 67; 66; 65 percentage of LVEF
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cardiac Saftey |
68; 67; 66; 65; 66 | — |
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
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. Informational only — not medical advice.