Predicting Response and Toxicity in Patients Receiving Chemotherapy for Breast Cancer: A Multicenter Genomic, Proteomic and Pharmacogenomic Correlative Study: Hoosier Oncology Group COE-01

Hoosier Cancer Research Network11 个研究点分布在 2 个国家目标入组 80 人开始时间: 2005年9月最近更新: 2015年12月9日

适应症

干预措施

试验速览

阶段: 不适用
状态: 终止
发起方
入组人数: 80
试验地点: 11
主要终点: To correlate tumor gene expression (genomic profile) with response to commonly used chemotherapies in patients with advanced 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 proposed trial provides a unique opportunity in that it combines genomic, proteomic, and pharmacogenomic assessments in patients receiving the most commonly used chemotherapies for advanced breast cancer. To date no other trial has analyzed gene and protein expression at the same time points in the same patient, combined with clinical outcome. Similar to previous attempts to predict response based on expression of a single gene or protein, the researchers expect that neither genomic or proteomic profiling alone will be sufficient to optimize therapy. Rather, the researchers expect an iterative process that combines information gleaned from both platforms, modified to avoid toxicity based on pharmacogenomics.

详细描述

OUTLINE: This is a 4 arm, multi-center study.

Sample Collection:

Core Biopsy
Serum
Urine

Treatment Regimens (Investigator/Patient Discretion):

Arm A: Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle
Arm B: Capecitabine 1000 mg/m2 BID days 1-14 of every 21-day cycle
Arm C: Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle
Arm D: Gemcitabine 1000 mg/m2 days 1, 8, 15 of every 28-day cycle

研究设计

研究类型: Observational
时间视角: Prospective

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

•Histologically or cytologically confirmed adenocarcinoma of the breast with locally advanced or metastatic disease.
•Disease amenable to pre-treatment core or incisional biopsy with adequate tissue for histology and genomic/proteomic analysis.
•Measurable disease as assessed within 21 days prior to being registered for protocol therapy by RECIST.
•Planned chemotherapy with one of the following regimens:
•Doxorubicin 60 mg/m2 + Cyclophosphamide 600 mg/m2 day 1 of every 21-day cycle
•Capecitabine 1000 mg/m2 BID days 1-14 of every 21-day cycle
•Vinorelbine 25 mg/m2 days 1, 8, 15 of every 28-day cycle
•Gemcitabine 1000 mg/m2 days 1, 8, 15 of every 28-day cycle

排除标准

•No serious uncontrolled medical or surgical condition that the investigator feels might compromise study participation.
•Negative pregnancy test obtained within 7 days prior to being registered for protocol therapy for women of child bearing potential.
•Unwillingness to use adequate contraception (or practicing complete abstinence). Subjects should be advised that adequate contraception (or complete abstinence) must be continued while on treatment and for a period of 3 months after the final dose of chemotherapy.
•No breast-feeding.

研究组 & 干预措施

D

Gemcitabine 1000mg/m2 days 1, 8, 15 of every 28-day cycle

干预措施: Serum Collection (Procedure)

D

Gemcitabine 1000mg/m2 days 1, 8, 15 of every 28-day cycle

干预措施: Urine Collection (Procedure)