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临床试验/NCT06210347
NCT06210347尚未招募不适用

Patterns of Relapse After Neoadjuvant Chemotherapy in Breast Cancer and Implications for Follow up in Clinical Practice

Assiut University0 个研究点目标入组 50 人开始时间: 2024年1月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
The patterns of relapse after Neoadjuvant Chemotherapy (NAC) for breast cancer to refine follow up recommendations.

研究概览

简要总结

This study aims to identify patterns of relapse after Neoadjuvant Chemotherapy (NAC) for breast cancer to refine follow up recommendations.

详细描述

Neoadjuvant chemotherapy (NAC) is usually used to facilitate breast-conserving surgery and improve surgical outcomes for breast cancer patients [1]. In addition, NAC can help to eradicate micrometastatic disease and serve to test chemosensitivity while providing similar survival benefits to adjuvant chemotherapy [2-5] .

Pathologic complete response (pCR) after neoadjuvant chemotherapy is associated with superior survival outcomes, with higher rates of pCR in human epidermal growth factor receptor 2 positive (HER2+) and triple negative breast cancer (TNBC) subtypes compared to hormone receptor (HR)-positive subtypes [6-7] .

Patients who achieve pCR also remain at signifcant risk of relapse, with studies reporting 5-year disease-free survival (DFS) rates of 75-87% [2,8-10] . Retrospective study of 88 Japanese patients who achieved pCR reported a recurrence rate of 13.6% and all relapses occurred within 32 months from diagnosis [11].

There for, little is known about the patterns of relapse after NAC especially in the real world. There are currently no specific guidelines for post-treatment follow-up of patients treated with NAC and variations in practice exist. So, this study aims to evaluate the relapse risks in different subgroups of breast cancers treated with NAC and determine the associated time trends and patterns of relapse in these patients. These findings may potentially lead to the development of risk-adapted surveillance strategies for patients treated with NAC

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
18 Years 至 100 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients aged >= 18
  • Pathologically proved breast cancer
  • PS 0-1 (ECOG)
  • Patients indicated to receive NAC

排除标准

  • Patients with metastatic disease at diagnosis
  • Patients who did not undergo subsequent curative intent surgery
  • Those who received Neoadjuvant hormonal treatment
  • Those that had incomplete treatment information

结局指标

主要结局

The patterns of relapse after Neoadjuvant Chemotherapy (NAC) for breast cancer to refine follow up recommendations.

时间窗: 2 years

Patterns of relapse after Neoadjuvant Chemotherapy (NAC) in breast cancer patients to refine follow up recommendations.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nour Salah Khairallah

Patterns of Relapse After Neoadjuvant Chemotherapy in Breast Cancer and Implications for Follow up in Clinical Practice

Assiut University

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