Clinical trial NCT03924609: Impact of Intensive Follow-up for Bone Metastasis on Characteristics and Prognosis of Chinese Breast Cancer Patients
Official title: Impact of Intensive Follow-up for Bone Metastasis on Characteristics and Prognosis of Chinese Breast Cancer Patients: A Multicenter Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Bone Metastases
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Fudan University
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Sun Yat-sen University
name: Harbin Medical University
First posted: 2019-04-23
Enrollment: 1500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1500 breast cancer patients with bone metastasis diagnosed between 2006 and 2011

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.

Eligibility 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

Primary outcomes:
measure: Overall survival
timeFrame: 60 months, and bone scan is repeated every 12 months
Secondary outcomes:
measure: disease-free survival
timeFrame: 60 months, and bone scan is repeated every 12 months
measure: distant metastasis-free survival
timeFrame: 60 months, and bone scan is repeated every 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Peking University People's Hospital
name: Shu Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
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