Phase II Study of Dose-Dense Doxurubicin and Cyclophosphamide (AC) Followed By Paclitaxel With Trastuzumab in HER2/ NEU-Amplified Breast Cancer: Feasibility
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Cardiac Saftey
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
1
single arm study
干预措施: AC [Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)] Followed By Paclitaxel (P) (Drug)
结局指标
主要结局
Cardiac Saftey
时间窗: Baseline-18 months
LVEF by Muga scan
次要结局
未报告次要终点