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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

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

Clinicaltrials.gov identifier NCT03924609

Recruitment Status Completed

First Posted April 23, 2019

Last update posted April 23, 2019

Study Description

Brief summary:

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.

  • Condition or Disease:Breast Cancer
    Bone Metastases
  • Intervention/Treatment: Diagnostic Test: Intensive screening / routine screening
  • Phase: N/A
Detailed Description

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.

Study Design
  • Study Type: Observational
  • Actual Enrollment: 1500 participants
  • Observational Model: Cohort
  • Time Perspective: Retrospective
  • Official Title: Impact of Intensive Follow-up for Bone Metastasis on Characteristics and Prognosis of Chinese Breast Cancer Patients: A Multicenter Retrospective Study
  • Actual Study Start Date: March 2018
  • Actual Primary Completion Date: March 2019
  • Actual Study Completion Date: March 2019
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: Bone metastasis screening
The information about bone metastasis screening is retrospectively collected.
Diagnostic Test: Intensive screening / routine screening
Recommendation and results of bone imaging such as bone scan or PET/CT, or bone CT /MR are collected.
Outcome Measures
  • Primary Outcome Measures: 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 Outcome Measures: 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
Eligibility Criteria
  • Ages Eligible for Study: 18 to 70 Years (Adult, Older Adult)
  • Sexes Eligible for Study: Female
  • Accepts Healthy Volunteers:
  • Sampling Method: Probability Sample
  • Study Population: 1500 breast cancer patients with bone metastasis diagnosed between 2006 and 2011
Criteria

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:

1. . Multiple bone metastases indicated by bone scan

2. . Bone scan positive, and proven by other imaging examinations, including computed
tomography (CT), magnetic resonance imaging (MRI) and X-ray.

3. . Bone scan positive, with clinical symptoms, including bone pain, pathologic
fracture, spinal cord compression and so on.

4. . Bone metastases indicated by PET-CT

5. . 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

Contacts and Locations
Contacts
Locations

China, Beijing
Peking University People's Hospital
Beijing

Sponsors and Collaborators

Peking University People's Hospital

Fudan University

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Sun Yat-sen University

Harbin Medical University

Investigators

Principal Investigator: Shu Wang, MD Peking University People's Hospital

More Information