Multicenter Pilot Clinical Study of Adjuvant Chemotherapy for Subjects Over 70 Years: Impact on the Independence and Quality of Life of the Administration of Anthracycline-Based Chemotherapy in Adjuvant Setting for Patients Presenting With Immediately Operable Breast Cancer, Hormone Receptor Negative (RH-), and Lymph Node Positive (pN+) or pN0 But of Scarff-Bloom-Richardson* Grade III and ≥ 2cm [GERICO]
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UNICANCER
- 入组人数
- 40
- 试验地点
- 17
- 主要终点
- Percentage of patients maintaining their independence as assessed by Activities of Daily Living (ADL) score on 6 items after the fourth course of chemotherapy
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as doxorubicin and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well giving doxorubicin together with cyclophosphamide works in treating older women with stage I , stage II, or stage III breast cancer that has been removed by surgery.
详细描述
OBJECTIVES:
Primary
- Determine the independence of older women with resected stage I, II, or III breast cancer treated with adjuvant doxorubicin hydrochloride and cyclophosphamide.
Secondary
- Determine the impact of this regimen on other aspects of the patient's life, utilizing the Comprehensive Geriatric Assessment, the Mini-Nutritional Assessment, the Folstein Mini-Mental State Exam, the Geriatric Depression Scale, and the Cumulative Illness Rating Scale-Geriatrics.
- Determine the quality of life of patients treated with this regimen.
- Determine the acceptability of this regimen in these patients.
- Determine the toxicity of this regimen, in terms of cardiac issues and anemia, in these patients.
- Determine recurrence-free survival, event-free survival, and overall survival of patients treated with this regimen.
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
- 70 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Myocet, Endoxan
干预措施: cyclophosphamide (Drug)
Myocet, Endoxan
干预措施: doxorubicin hydrochloride (Drug)
Myocet, Endoxan
干预措施: AC regimen (Drug)
Myocet, Endoxan
干预措施: adjuvant therapy (Procedure)
Myocet, Endoxan
干预措施: cognitive assessment (Procedure)
Myocet, Endoxan
干预措施: management of therapy complications (Procedure)
Myocet, Endoxan
干预措施: psychosocial assessment and care (Procedure)
Myocet, Endoxan
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Percentage of patients maintaining their independence as assessed by Activities of Daily Living (ADL) score on 6 items after the fourth course of chemotherapy
时间窗: 12 weeks
次要结局
- Impact of adjuvant chemotherapy on ADL score, quality of life, treatment acceptability, toxicity, and survival (recurrence-free, progression-free, and overall survival)(3 years)