Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The liver represents the third most common site of breast cancer (BC) metastases behind the lymphatics and bone. The primary treatment for BCLM remains chemo-therapy and, more recently, targeted immunotherapy. The role of liver resection in BCLM remains controversial. The primary aim of the study is to compare the efficacy of liver resection vs. medical therapy alone in Breast Cancer Liver Metastasis (BCLM) patients.
In this multicenter observational ambispective study, will be enrolled all patients with BCLM underwent liver resection or medical treatment alone afferent to the Fondazione Policlinico Gemelli IRCSS of Rome (Italy), and other 8 International centers
The study foresees two distinct phases:
The primary endpoint is to analyze the efficacy of liver surgery as compared to medical therapy alone in terms of 5-years overall survival in patients with breast cancer who underwent to liver resection or medical therapy alone.
The secondary endpoints are: recurrence rate; post-operative mortality (in patients who underwent to surgical treatment), post-operative complication (in patients who underwent to surgical treatment). And also: to assess potential predictive factors of 5-years overall survival in patients with breast cancer who underwent to either liver resection or medical therapy alone, to assess recurrence free survival (RFS) of liver surgery as compared to medical therapy alone in terms of 5-years overall survival in patients with breast cancer who underwent to liver resection or medical therapy alone and to assess potential predictive factors of 5-years RFS in patients with breast cancer who underwent to either liver resection or medical therapy alone.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BCLM-surg | BCLM underwent liver resection | ||
| BCLM-med | BCLM underwent medical treatment alone |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 5-years overall survival | The efficacy of liver surgery as compared to medical therapy alone in terms of 5-years overall survival in patients with breast cancer | 2018-2023 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
All patient with BCLM underwent liver resection or medical treatment alone.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amelia Mattia, MD | Contact | +390453015 | 4868 | amelia.mattia01@icatt.it |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Recruiting | Rome | Lazio | 00168 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19482250 | Background | Diamond JR, Finlayson CA, Borges VF. Hepatic complications of breast cancer. Lancet Oncol. 2009 Jun;10(6):615-21. doi: 10.1016/S1470-2045(09)70029-4. | |
| 30846407 | Background | Arciero CA, Guo Y, Jiang R, Behera M, O'Regan R, Peng L, Li X. ER+/HER2+ Breast Cancer Has Different Metastatic Patterns and Better Survival Than ER-/HER2+ Breast Cancer. Clin Breast Cancer. 2019 Aug;19(4):236-245. doi: 10.1016/j.clbc.2019.02.001. Epub 2019 Feb 14. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 1, 2023 | Oct 15, 2023 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 1, 2023 | Oct 15, 2023 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 25885919 | Background | Ma R, Feng Y, Lin S, Chen J, Lin H, Liang X, Zheng H, Cai X. Mechanisms involved in breast cancer liver metastasis. J Transl Med. 2015 Feb 15;13:64. doi: 10.1186/s12967-015-0425-0. |
| 31577379 | Background | DeSantis CE, Ma J, Gaudet MM, Newman LA, Miller KD, Goding Sauer A, Jemal A, Siegel RL. Breast cancer statistics, 2019. CA Cancer J Clin. 2019 Nov;69(6):438-451. doi: 10.3322/caac.21583. Epub 2019 Oct 2. |
| 33433946 | Background | Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12. |
| 21281746 | Background | Howlader M, Heaton N, Rela M. Resection of liver metastases from breast cancer: towards a management guideline. Int J Surg. 2011;9(4):285-91. doi: 10.1016/j.ijsu.2011.01.009. Epub 2011 Jan 31. |
| 28196771 | Background | Golse N, Adam R. Liver Metastases From Breast Cancer: What Role for Surgery? Indications and Results. Clin Breast Cancer. 2017 Jul;17(4):256-265. doi: 10.1016/j.clbc.2016.12.012. Epub 2017 Jan 9. |
| 33675501 | Background | Rashid NS, Grible JM, Clevenger CV, Harrell JC. Breast cancer liver metastasis: current and future treatment approaches. Clin Exp Metastasis. 2021 Jun;38(3):263-277. doi: 10.1007/s10585-021-10080-4. Epub 2021 Mar 6. |
| 26445472 | Background | Sadot E, Lee SY, Sofocleous CT, Solomon SB, Gonen M, Kingham TP, Allen PJ, DeMatteo RP, Jarnagin WR, Hudis CA, D'Angelica MI. Hepatic Resection or Ablation for Isolated Breast Cancer Liver Metastasis: A Case-control Study With Comparison to Medically Treated Patients. Ann Surg. 2016 Jul;264(1):147-154. doi: 10.1097/SLA.0000000000001371. |
| 29579478 | Background | Ruiz A, van Hillegersberg R, Siesling S, Castro-Benitez C, Sebagh M, Wicherts DA, de Ligt KM, Goense L, Giacchetti S, Castaing D, Morere J, Adam R. Surgical resection versus systemic therapy for breast cancer liver metastases: Results of a European case matched comparison. Eur J Cancer. 2018 May;95:1-10. doi: 10.1016/j.ejca.2018.02.024. Epub 2018 Mar 23. |
| 24126165 | Background | Mariani P, Servois V, De Rycke Y, Bennett SP, Feron JG, Almubarak MM, Reyal F, Baranger B, Pierga JY, Salmon RJ. Liver metastases from breast cancer: Surgical resection or not? A case-matched control study in highly selected patients. Eur J Surg Oncol. 2013 Dec;39(12):1377-83. doi: 10.1016/j.ejso.2013.09.021. Epub 2013 Oct 6. |
| 12111882 | Background | Lakatos E. Designing complex group sequential survival trials. Stat Med. 2002 Jul 30;21(14):1969-89. doi: 10.1002/sim.1193. |
| 19472308 | Background | Schemper M, Wakounig S, Heinze G. The estimation of average hazard ratios by weighted Cox regression. Stat Med. 2009 Aug 30;28(19):2473-89. doi: 10.1002/sim.3623. |
| 29966490 | Background | van Smeden M, Moons KG, de Groot JA, Collins GS, Altman DG, Eijkemans MJ, Reitsma JB. Sample size for binary logistic prediction models: Beyond events per variable criteria. Stat Methods Med Res. 2019 Aug;28(8):2455-2474. doi: 10.1177/0962280218784726. Epub 2018 Jul 3. |
| 25560730 | Background | Moons KG, Altman DG, Reitsma JB, Ioannidis JP, Macaskill P, Steyerberg EW, Vickers AJ, Ransohoff DF, Collins GS. Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD): explanation and elaboration. Ann Intern Med. 2015 Jan 6;162(1):W1-73. doi: 10.7326/M14-0698. |
| D017437 |
| Skin and Connective Tissue Diseases |