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临床试验/NCT06010615
NCT06010615尚未招募不适用

Relative Dose Intensity of Adjuvant Chemotherapy in Older Women With ER+ HER2- Breast Cancer.

Centre Hospitalier Universitaire de Besancon0 个研究点目标入组 70 人开始时间: 2023年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
主要终点
Proportion of patients receiving relative dose intensity (RDI) <85%

研究概览

简要总结

Localized breast cancers are defined as high-risk when they include lymph node involvement, Ki67 >30%, vascular emboli, low hormone receptor expression, or an unfavorable genomic signature result.

Under these conditions, sequential adjuvant chemotherapy with taxanes and anthracyclines is recommended.

Patients over 75 years of age receiving adjuvant chemotherapy are at greater risk of side-effects, which may necessitate dose reductions and a reduction in the intensity of chemotherapy. For curative adjuvant treatment, it is recommended to maintain a relative dose intensity (RDI) > 85%. A few publications have demonstrated the prognostic impact of a relative dose intensity < 85% for patients aged over 65. For several years now, the need for a specific assessment of elderly patients has been emphasized, prior to initiating oncological treatment (G8 score, onco-geriatric consultation).

This study is a retrospective descriptive study of patients aged over 75 treated with adjuvant chemotherapy from 01/01/2012 to 01/01/2020 for RH+ HER2 - breast cancer in Franche Comté.

Thus the investigators wish to identify patients at risk of receiving sub-optimal relative dose intensity, in order to guide early and targeted supportive care or geriatric co-management interventions.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
75 Years 至 —(Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 75 or over
  • Patient with localized RH+HER2- breast cancer
  • Patient treated with adjuvant chemotherapy in Franche Comté between January 2012 and December 2019

排除标准

  • Age < 75
  • Patient with metastatic breast cancer
  • Patient who received neoadjuvant chemotherapy
  • HER2+ breast cancer patient
  • Breast cancer patient with missing or negative hormonal status
  • Patient with localized recurrence of breast cancer with indication for new adjuvant therapy

结局指标

主要结局

Proportion of patients receiving relative dose intensity (RDI) <85%

时间窗: 01/01/2012 to 31/12/2019

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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