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临床试验/NCT01038258
NCT01038258Unknown不适用

Monitoring Response After The First Chemotherapy Cycle In Newly Diagnosed Breast Cancer As A Guide For Neoadjuvant Therapy

Auxilio Mutuo Cancer Center2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2007年7月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
2
主要终点
Pathologic response

研究概览

简要总结

A PET scan drop less than 20% in SUVs or below a certain absolute SUV value after the first course of neoadjuvant chemotherapy can predict pathological response, and could in the future lead to an early surgical intervention.

详细描述

The use of neo-adjuvant systemic therapy in women recently diagnosed with breast cancer is growing in popularity based on its proven benefit (1). Pre-operative chemotherapy not only can assist in regards to breast conservation therapy (2) but data suggest prognostic benefits in those subset of patient's obtaining complete pathological response (3,4) .

It is imperative for clinicians to detect as early as possible those patients likely to obtain the desired clinical and /or pathologic response, thus identifying those patients who don't benefit from the first line neoadjuvant treatment so that their treatment can be modified accordingly.

Response to treatment based on clinical data or structural imaging, usually requires several chemotherapeutic cycles to establish degree of effectiveness (5). Lately, FDG-PET/CT has been used in different types of neoplasms, breast cancer among them, to establish early response to treatment (6,7). Recent data has established the usefulness of metabolic analysis via FDG-PET, in separating subgroups of chemotherapy. For such analytical approach, sequential estimation of SUVs (Standardized Uptake Value) have been measured along the duration of the treatment. Reduction in SUVs presumes adequate response to treatment (8), while little or no change in metabolic activity presumes sub-optimal response .

However, no definite consensus has been established in regards to what degree of metabolic response is predictive of the desired clinical benefit, particularly early in the treatment . Establishing such criteria could potentially serve as a guideline for monitoring neoadjuvant treatment. Schelling et al, was able to separate a group of patients that eventually showed either progression of the disease or no clinical response as early as the first course of chemotherapy.

The aim of our study is to establish a simple formula using FDG-PET/CT, as early as the first course of chemotherapy, to stratify patients undergoing neoadjuvant chemotherapy for recently diagnosed breast cancer. Those who will benefit from continuing the same treatment will be regarded as responders versus non-responders, which are those in need of changing strategy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Recently diagnosed breast carcinoma that will receive neoadjuvant chemotherapy based on: Tumors size greater than 2 cms; Locally advanced tumors, Tumors close to or invading chest wall or areola and/or Inflammatory Breast cancer.
  • 18 years of age.
  • Available for follow-up visits
  • Able to comply with study requirements.
  • Have signed an IRB approved written informed consent form

排除标准

  • Any significant medical or psychiatric illness, which would prevent the patient from giving informed consent or following the study procedures.
  • Pregnant and Nursing women.
  • No restriction will be placed on the chemotherapy regimen used although we expect that most patients will receive Anthracycline based regimens.

结局指标

主要结局

Pathologic response

时间窗: After 1st course of chemo and after definitive surgery

次要结局

未报告次要终点

研究者

发起方
Auxilio Mutuo Cancer Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fernando Cabanillas

Hematology-Oncologist

Auxilio Mutuo Cancer Center

研究点 (2)

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