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Completed

NCT Number: NCT03924609

Impact of Intensive Follow-up for Bone Metastasis on Characteristics and Prognosis of Chinese Breast Cancer Patients

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.

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Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Intensive screening / routine screening

Diagnostic Test

Recommendation and results of bone imaging such as bone scan or PET/CT, or bone CT /MR are collected.

Primary outcomes

  1. Overall survival

    Time frame: 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

Secondary outcomes

  1. disease-free survival

    Time frame: 60 months, and bone scan is repeated every 12 months

    defined as time to disease recurrence (invasive local, regional, or distant metastasis) or death from any cause

  2. distant metastasis-free survival

    Time frame: 60 months, and bone scan is repeated every 12 months

    defined as time to distant metastasis

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Collaborators

  • Fudan University
  • Harbin Medical University
  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  • Sun Yat-sen University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 23, 2019
Registry last updated
Apr 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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