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临床试验/NCT06131632
NCT06131632尚未招募不适用

Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy in Patients With Clinical Complete Response (ConSIBreC): a Randomized Clinical Trial

Fondazione Policlinico Universitario Agostino Gemelli IRCCS2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年3月1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
300
试验地点
2
主要终点
local recurrence rate

研究概览

简要总结

Inflammatory breast cancer is an aggressive and rare form of breast cancer, which accounts for 2-3% of all breast cancers. The classic presentation of inflammatory breast cancer includes erythema, edema, and peau d'orange of at least one/third of the breast.

Current treatment of inflammatory breast cancer include: neoadjuvant chemiotherapy, modified radical mastectomy and radiation therapy.

In the last two decades the development of new targeted therapies has significantly improved the efficacy of neoadjuvant chemiotherapy allowing a de-escalation of surgical treatment in patients with non-inflammatory breast cancer that achieve clinical complete response.

There are few retrospective studies that evaluate implications of surgical treatment on survival among these patients. This may justify trial aims to investigate the possible use of the breast conserving surgery in patients with inflammatory breast cancer that achieve clinical complete response after neoadjuvant chemiotherapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with inflammatory breast cancer
  • Clinical complete response after neoadjuvant chemiotherapy
  • Targeted tumor
  • Written informed consent

排除标准

  • Metastasis
  • Progression disease
  • Recurrent disease
  • Contraindications to adjuvant radiation therapy

结局指标

主要结局

local recurrence rate

时间窗: 24 months

Rate of recurrence in the breast parenchyma after conserving surgery vs radical mastectomy

次要结局

  • local recurrence-free survival(24 months)
  • overall survival(24 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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