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临床试验/NCT03924609
NCT03924609已完成不适用

Impact of Intensive Follow-up for Bone Metastasis on Characteristics and Prognosis of Chinese Breast Cancer Patients: A Multicenter Retrospective Study

Peking University People's Hospital1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,500
试验地点
1
主要终点
Overall survival

研究概览

简要总结

The purpose of this study is to retrospectively collect and analyse the characteristics of breast cancer patients with bone metastasis, and compare the impact of intensive follow-up with standard post-operative surveillance on survival of Chinese breast cancer patients.

详细描述

Breast cancer is one of the most common malignant tumors in women, and the incidence rate is gradually increasing, accounts for the first place in the incidence of female malignant tumors. Bone metastasis is the most common distant metastatic site for breast cancer, accounting for approximately 70% of all patients with advanced breast cancer. About 26%-50% of breast cancer patients with primary metastases are bone. Autopsy results showed that the overall incidence of breast cancer bone metastasis was about 47%-85%.

Postoperative routine screening for bone metastases in breast cancer patients, whether domestic or foreign, is not recommended in most guidelines. These recommendations were based on two prospective randomized controlled trials in Italy in 1990s, indicated that a bone scan every six months or annually didn't provide a survival benefit to the patient. However, there were researches showing that about 11% of patients with asymptomatic breast cancer have bone metastases, suggesting that early screening might detect more patients with asymptomatic bone metastases. The meta-analysis also pointed out that early screening may prolong the disease-free survival of patients. Besides, the imaging techniques have advance rapidly and remarkably since then. New trials are needed to figure out whether imaging screening of asymptomatic patients should be routinely performed to detect more asymptomatic bone metastases needs further investigation.

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 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • A. Histologically proven breast cancer confirmed by biopsy or pathological examination of the resected tumor.
  • B. Histologically confirmed breast cancer patients, fulfilling any of the following:
  • . Multiple bone metastases indicated by bone scan
  • . Bone scan positive, and proven by other imaging examinations, including computed tomography (CT), magnetic resonance imaging (MRI) and X-ray.
  • . Bone scan positive, with clinical symptoms, including bone pain, pathologic fracture, spinal cord compression and so on.
  • . Bone metastases indicated by PET-CT
  • . Histologically proven bone metastases

排除标准

  • A. No bone metastases confirmed by pathological examination B. Bone metastases secondary to other malignant tumor other than breast cancer C. Secondary primary tumor

结局指标

主要结局

Overall survival

时间窗: 60 months, and bone scan is repeated every 12 months

defined as the period from randomization to death from any cause, and it is censored at the last follow-up date when the patient is alive

次要结局

  • distant metastasis-free survival(60 months, and bone scan is repeated every 12 months)
  • disease-free survival(60 months, and bone scan is repeated every 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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