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

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

Sponsors

Lead sponsor: Peking University People's Hospital

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

Source Peking University People's Hospital
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.

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.

Overall Status Completed
Start Date March 1, 2018
Completion Date March 31, 2019
Primary Completion Date March 31, 2019
Study Type Observational
Primary Outcome
Measure Time Frame
Overall survival 60 months, and bone scan is repeated every 12 months
Secondary Outcome
Measure Time Frame
disease-free survival 60 months, and bone scan is repeated every 12 months
distant metastasis-free survival 60 months, and bone scan is repeated every 12 months
Enrollment 1500
Condition
Intervention

Intervention type: Diagnostic Test

Intervention name: Intensive screening / routine screening

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

Arm group label: Bone metastasis screening

Eligibility

Sampling method: Probability Sample

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

Gender: Female

Minimum age: 18 Years

Maximum age: 70 Years

Overall Official
Last Name Role Affiliation
Shu Wang, MD Principal Investigator Peking University People's Hospital
Location
facility Peking University People's Hospital
Location Countries

China

Verification Date

April 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Bone metastasis screening

Description: The information about bone metastasis screening is retrospectively collected.

Study Design Info

Observational model: Cohort

Time perspective: Retrospective

Source: ClinicalTrials.gov