Clinical trial · Observational
Impact of Intensive Follow-up for Bone Metastasis on Characteristics and Prognosis of Chinese Breast Cancer Patients
Impact of Intensive Follow-up for Bone Metastasis on Characteristics and Prognosis of Chinese Breast Cancer Patients: A Multicenter Retrospective Study
NCT03924609CI-TRIAL-00038294completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Metastases | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensive screening / routine screening | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Bone metastasis screening
- description
- The information about bone metastasis screening is retrospectively collected.
- interventionNames
- Diagnostic Test: Intensive screening / routine screening
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- 60 months, and bone scan is repeated every 12 months
- description
- 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 outcomes (2)
- measure
- disease-free survival
- timeFrame
- 60 months, and bone scan is repeated every 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (11)
- BACKGROUNDRosselli 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. doi: 10.1001/jama.271.20.1593. PMID 7848404
- BACKGROUNDImpact 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. doi: 10.1001/jama.1994.03510440047031. PMID 8182811
- BACKGROUNDPalli 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. doi: 10.1001/jama.281.17.1586. No abstract available. PMID 10235147
- BACKGROUNDRojas 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. doi: 10.1002/14651858.CD001768.pub2. PMID 15674884
- BACKGROUNDGradishar 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. doi: 10.6004/jnccn.2016.0037. PMID 26957618
- BACKGROUNDKhatcheressian 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.