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临床试验/NCT00193115
NCT00193115已完成2 期

Phase II Pilot Trial of Dose-Dense Docetaxel Followed by Doxorubicin Plus Cyclophosphamide (T-AC) Given as Adjuvant or Neoadjuvant Treatment for Women With Node Positive or High-Risk Primary Breast Cancer

SCRI Development Innovations, LLC0 个研究点目标入组 32 人开始时间: 2004年3月最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
32
主要终点
Treatment-related toxicities

研究概览

简要总结

This protocol will evaluate the feasibility and toxicity of dose-dense docetaxel followed by doxorubicin and cyclophosphamide with support given as adjuvant or neoadjuvant treatment of women with node positive and high risk breast cancer

详细描述

Upon determination of eligibility, patients will receive:

Neoadjuvant Docetaxel + Doxorubicin + Cyclophosphamide + Surgery

Adjuvant patients will enter the study after surgery and receive Docetaxel+ Doxorubicin + Cyclophosphamide. Patients treated with lumpectomy will undergo postoperative radiation therapy after completion of chemotherapy. Patients with positive estrogen and/or progesterone receptors will begin anti-estrogen therapy after the last course of chemotherapy.

研究设计

研究类型
Interventional
分配方式
Non Randomized
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

入选标准

  • To be included in this study, you must meet the following criteria:
  • Histologically proven breast cancer
  • Females, age greater than 18 years
  • Ability to perform activites of daily living with minimal assistance
  • Normal cardiac function
  • Adequate bone marrow, liver and kidney
  • Signed informed consent prior to beginning specific protocol procedures

排除标准

  • You cannot participate in this study if any of the following apply to you:
  • Prior systemic anticancer therapy for breast cancer
  • Prior anthracycline or taxane based chemotherapy for any malignancy
  • Pregnant or breast-feeding women.
  • Pre-existing moderate to severe motor or sensory neurotoxicity
  • Other serious illness or medical condition
  • Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

结局指标

主要结局

Treatment-related toxicities

次要结局

  • Overall response rate
  • Overall survival

研究者

申办方类型
Other

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