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Impact of Intensive Follow-up for Bone Metastasis on Characteristics and Prognosis of Chinese Breast Cancer Patients
| Condition or disease | Intervention/treatment |
|---|---|
| Breast Cancer Bone Metastases | Diagnostic Test: Intensive screening / routine screening |
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 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 1, 2018 |
| Actual Primary Completion Date : | March 31, 2019 |
| Actual Study Completion Date : | March 31, 2019 |
| Group/Cohort | 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.
|
- 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
- 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
- distant metastasis-free survival [ Time Frame: 60 months, and bone scan is repeated every 12 months ]defined as time to distant metastasis
| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Sampling Method: | Probability Sample |
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
| China, Beijing | |
| Peking University People's Hospital | |
| Beijing, Beijing, China, 100044 | |
| Principal Investigator: | Shu Wang, MD | Peking University People's Hospital |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | March 8, 2019 | ||||
| First Posted Date | April 23, 2019 | ||||
| Last Update Posted Date | April 23, 2019 | ||||
| Actual Study Start Date | March 1, 2018 | ||||
| Actual Primary Completion Date | March 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
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
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | 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 | ||||
| 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. |
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| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | 1500 breast cancer patients with bone metastasis diagnosed between 2006 and 2011 | ||||
| Condition |
|
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| Intervention | 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.
|
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| Study Groups/Cohorts | Bone metastasis screening
The information about bone metastasis screening is retrospectively collected.
Intervention: Diagnostic Test: Intensive screening / routine screening
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
1500 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | March 31, 2019 | ||||
| Actual Primary Completion Date | March 31, 2019 (Final data collection date for primary outcome measure) | ||||
| 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:
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 |
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| Sex/Gender |
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| Ages | 18 Years to 70 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03924609 | ||||
| Other Study ID Numbers | 20160504 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Peking University People's Hospital | ||||
| Study Sponsor | Peking University People's Hospital | ||||
| Collaborators |
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| Investigators |
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| PRS Account | Peking University People's Hospital | ||||
| Verification Date | April 2019 | ||||
