Surgical or Medical Treatment of Breast Cancer Metastasis: A Multicentre Observational Study

Breast Cancer Clinical Trial

— SurMed-BCLM  

Official title:

Surgical or Medical Treatment of Breast Cancer Metastasis: A Multicentre Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06093022
• Other study ID #: 5795
• Status: Recruiting
• Start date: April 1, 2018
• Est. completion date: December 31, 2028

Study information

• Verified date: September 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Amelia Mattia, MD
• Phone: +390453015
• Email: amelia.mattia01[@]icatt.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Description:

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:

• I phase (only retrospective phase): it will cover all patients underwent to either medical treatment or surgery for which all data are available, with a follow up of 5 years at March 31, 2023. All patients data will be recovered from January 1994 till March 31, 2018. At the end of "phase I", is provided an "ad interim" analysis.

• II phase (ambispective): All patients retrieved from the archives between April 1, 2018 and the April 30, 2023 will be included, as well as all prospectively enrolled patients till December 31 2023, so that the last patient enrolled will end the 5-years follow-up phase within December 31, 2028.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 720
• Est. completion date: December 31, 2028
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• > 18 years old

• BCLM

• BCLM and extra-hepatic disease

• Any treatment

• Ability to understand and sign the informed consent

Exclusion Criteria:

• Inability to provide the informed consent

• Patient who underwent Best Supportive Care or Palliation

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Liver Metastases
• Neoplasm Metastasis

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Lazio

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Lakatos E. Designing complex group sequential survival trials. Stat Med. 2002 Jul 30;21(14):1969-89. doi: 10.1002/sim.1193. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: CA Cancer J Clin. 2021 Jul;71(4):359. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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