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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03924609
• Other study ID #: 20160504
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: March 31, 2019

Study information

• Verified date: April 2019
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: March 31, 2019
• Est. primary completion date: March 31, 2019
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Bone Metastases
• Bone Neoplasms
• Breast Cancer
• Breast Neoplasms
• Neoplasm Metastasis

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.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (5)

Lead Sponsor	Collaborator
Peking University People's Hospital	Fudan University, Harbin Medical University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (11)

Coleman R, de Boer R, Eidtmann H, Llombart A, Davidson N, Neven P, von Minckwitz G, Sleeboom HP, Forbes J, Barrios C, Frassoldati A, Campbell I, Paija O, Martin N, Modi A, Bundred N. Zoledronic acid (zoledronate) for postmenopausal women with early breast cancer receiving adjuvant letrozole (ZO-FAST study): final 60-month results. Ann Oncol. 2013 Feb;24(2):398-405. doi: 10.1093/annonc/mds277. Epub 2012 Oct 9. — View Citation

Gong Y, Liu YR, Ji P, Hu X, Shao ZM. Impact of molecular subtypes on metastatic breast cancer patients: a SEER population-based study. Sci Rep. 2017 Mar 27;7:45411. doi: 10.1038/srep45411. — View Citation

Gradishar WJ, Anderson BO, Balassanian R, Blair SL, Burstein HJ, Cyr A, Elias AD, Farrar WB, Forero A, Giordano SH, Goetz M, Goldstein LJ, Hudis CA, Isakoff SJ, Marcom PK, Mayer IA, McCormick B, Moran M, Patel SA, Pierce LJ, Reed EC, Salerno KE, Schwartzberg LS, Smith KL, Smith ML, Soliman H, Somlo G, Telli M, Ward JH, Shead DA, Kumar R. Invasive Breast Cancer Version 1.2016, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2016 Mar;14(3):324-54. — View Citation

Impact of follow-up testing on survival and health-related quality of life in breast cancer patients. A multicenter randomized controlled trial. The GIVIO Investigators. JAMA. 1994 May 25;271(20):1587-92. — View Citation

Khatcheressian JL, Hurley P, Bantug E, Esserman LJ, Grunfeld E, Halberg F, Hantel A, Henry NL, Muss HB, Smith TJ, Vogel VG, Wolff AC, Somerfield MR, Davidson NE; American Society of Clinical Oncology. Breast cancer follow-up and management after primary treatment: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2013 Mar 1;31(7):961-5. doi: 10.1200/JCO.2012.45.9859. Epub 2012 Nov 5. Review. — View Citation

Palli D, Russo A, Saieva C, Ciatto S, Rosselli Del Turco M, Distante V, Pacini P. Intensive vs clinical follow-up after treatment of primary breast cancer: 10-year update of a randomized trial. National Research Council Project on Breast Cancer Follow-up. JAMA. 1999 May 5;281(17):1586. — View Citation

Rojas MP, Telaro E, Russo A, Moschetti I, Coe L, Fossati R, Palli D, del Roselli TM, Liberati A. Follow-up strategies for women treated for early breast cancer. Cochrane Database Syst Rev. 2005 Jan 25;(1):CD001768. Review. Update in: Cochrane Database Syst Rev. 2016;(5):CD001768. — View Citation

Rosselli Del Turco M, Palli D, Cariddi A, Ciatto S, Pacini P, Distante V. Intensive diagnostic follow-up after treatment of primary breast cancer. A randomized trial. National Research Council Project on Breast Cancer follow-up. JAMA. 1994 May 25;271(20):1593-7. — View Citation

Xiong Z, Deng G, Huang X, Li X, Xie X, Wang J, Shuang Z, Wang X. Bone metastasis pattern in initial metastatic breast cancer: a population-based study. Cancer Manag Res. 2018 Feb 9;10:287-295. doi: 10.2147/CMAR.S155524. eCollection 2018. — View Citation

Yong M, Jensen AÖ, Jacobsen JB, Nørgaard M, Fryzek JP, Sørensen HT. Survival in breast cancer patients with bone metastases and skeletal-related events: a population-based cohort study in Denmark (1999-2007). Breast Cancer Res Treat. 2011 Sep;129(2):495-503. doi: 10.1007/s10549-011-1475-5. Epub 2011 Apr 2. — View Citation

Zhang H, Zhu W, Biskup E, Yang W, Yang Z, Wang H, Qiu X, Zhang C, Hu G, Hu G. Incidence, risk factors and prognostic characteristics of bone metastases and skeletal-related events (SREs) in breast cancer patients: A systematic review of the real world data. J Bone Oncol. 2018 Feb 3;11:38-50. doi: 10.1016/j.jbo.2018.01.004. eCollection 2018 Jun. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	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	60 months, and bone scan is repeated every 12 months
Secondary	disease-free survival	defined as time to disease recurrence (invasive local, regional, or distant metastasis) or death from any cause	60 months, and bone scan is repeated every 12 months
Secondary	distant metastasis-free survival	defined as time to distant metastasis	60 months, and bone scan is repeated every 12 months