A Phase II Trial of Preoperative Cisplatin and Bevacizumab in Estrogen Receptor (ER) Negative, Progesterone (PR) Negative, Human Epidermal Growth Factor Receptor 2 (HER2) Negative Breast Cancer

Massachusetts General Hospital3 个研究点分布在 1 个国家目标入组 51 人开始时间: 2007年9月最近更新: 2021年5月26日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Massachusetts General Hospital
入组人数: 51
试验地点: 3
主要终点: Pathologic Complete Response Rate After Preoperative Therapy With Cisplatin and Bevacizumab in ER-, PR-, Human Epidermal Growth Factor Receptor 2 (HER2) -Negative Early Breast Cancer.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to find out what effect taking cisplatin in combination with bevacizumab before surgery and then standard chemotherapy plus bevacizumab after surgery will have on participants with Estrogen Receptor (ER) negative, Progesterone Receptor (PR) negative and Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer. Cisplatin is used to destroy cancer cells in many types of cancers, and has shown to be effective and have manageable side effects. Bevacizumab is an antibody, which is a protein that attacks a foreign substance in the body. Bevacizumab slows or stops cell growth in cancerous tumors by decreasing the blood supply to the tumors.

详细描述

To prepare for surgery, a small "clip" will be placed into the tumor area so that the surgeon can locate the site of the tumor at the time of surgery. This is a standard procedure for breast cancer.
The study drugs will be given in four 3-week cycles (about 3 months). Participants will come into the clinic each day they receive study treatment intravenously. Cisplatin will be given on day one of the treatment cycle (once every 3 weeks) for four cycles. Bevacizumab will be given on day one of the treatment cycle for three cycles.
On day one of each 3-week cycle a physical exam, routine blood tests and urine test will be performed. 7-8 days after chemotherapy, blood tests and a hearing test will be performed. A preoperative study visit will take place 7-10 days before surgery and a physical exam, routine blood tests, Electrocardiogram (EKG) and an Magnetic Resonance Imaging (MRI) of the breast will be performed.
Surgery to remove the tumor will occur at least three weeks after the last dose of cisplatin and is considered standard of care.
Postoperative chemotherapy will begin at least three weeks after surgery. Everyone on the research study will receive four 2-week cycles of doxorubicin and cyclophosphamide plus bevacizumab. After the 8 weeks, the doctor will decide which of the following two treatment regimens the participant will receive: Bevacizumab for four 2-week cycles (once every two weeks) or; Paclitaxel plus bevacizumab for four 2-week cycles (once every two weeks).
At the end of the postoperative chemotherapy, the participant will return to the clinic for a medical history, physical exam, vital signs, performance status, routine blood tests, multiple gated acquisition scan (MUGA) or Echocardiogram Scans, and a hearing test.

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: All
接受健康志愿者: 否

入选标准

•All tumors must be ER-, PR- and HER2-negative
•Clinical stage T2 or T3, N0-3, M
•Subjects with inflammatory breast cancer are not eligible
•For subjects with clinically negative axilla, a sentinel lymph node biopsy will be performed either up front or after preoperative therapy at the discretion of the subject's physicians; for subjects with a clinically positive axilla, a needle aspiration or core biopsy will be performed to confirm the presence of metastatic disease in the lymph nodes.
•18 years of age or older
•Performance status (PS) of 0 or 1
•Use of an effective means of contraception in subjects of child-bearing potential
•Normal organ function as described in the protocol

排除标准

•Any prior cytotoxic chemotherapy or radiation for the current breast cancer
•HER2-negative ipsilateral breast recurrence, unless prior treatment consisted of excision alone for ductal carcinoma in situ (DCIS)or breast-conserving treatment and hormonal therapy for DCIS or invasive cancer
•Life expectancy of less than 12 weeks
•Current, recent, or planned participation in an experimental durg study other than a Genentech-sponsored bevacizumab cancer study
•Renal dysfunction for which exposure to cisplatin would require dose modifications
•Steroid dependent asthma
•Peripheral neuropathy of any etiology that exceeds grade 1
•Uncontrolled diabetes
•History of malignancy treated without curative intent
•Any other pre-existing medical condition that would represent toxicity in excess of grade 1
•Inadequately controlled hypertension
•Any prior history of hypertensive crisis or hypertensive encephalopathy
•New York Heart Association (NYHA) Grade II or greater congestive hear failure
•History of myocardial infarction or unstable angina within 12 months prior to study enrollment
•Any history of stroke or transient ischemic attack at any time
•Known central nervous system (CNS) disease
•Significant vascular disease
•Symptomatic peripheral vascular disease
•Evidence of bleeding diathesis or coagulopathy
•Major surgical procedure, open biopsy, or significant traumatic injury within 21 days prior to study enrollment
•History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months prior to study enrollment
•Serious, non-healing wound, ulcer or bone fracture
•Proteinuria at screening
•Known hypersensitivity to any component of bevacizumab
•Pregnant or lactating