Long-term Outcomes After Breast Cancer Liver Metastasis Surgery: an European, Retrospective, Snapshot Study

Breast Cancer Clinical Trial

— LIBREAST  

Official title:

LIBREAST STUDY: Long-term Outcomes After Breast Cancer Liver Metastasis Surgery: an European, Retrospective, Snapshot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04817813
• Other study ID #: PI20/596
• Status: Not yet recruiting
• Start date: March 15, 2021
• Est. completion date: July 31, 2021

Study information

• Verified date: March 2021
• Source: Hospital Miguel Servet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Breast cancer ranks as the top leading malignant tumors among females, and also accounts for the most common cause of tumor related mortality in females worldwide. Approximately, 20-30% of breast cancer cases develop metastasis, while 50% of patients will suffer from breast cancer liver metastasis. The proper indication for surgical treatment of breast cancer liver metastasis is still a matter of discussion. Surgery is becoming more practical and effective than conservative treatment in improving the outcomes of patients with breast cancer liver metastasis and liver metastasis surgery is included in an onco- surgical strategy.

Description:

Breast cancer ranks as the top leading malignant tumors among females, and also accounts for the most common cause of tumor related mortality in female's worldwide . Approximately, 20-30% of breast cancer (BC) cases develop metastasis, while 50% of patients will suffer from breast cancer liver metastases (BCLM) . The presence of liver metastasis has markedly worsened the prognosis of patients, and the median survival was reported to be 3.8-29 months.

Metastatic breast cancer is considered to be a disseminated disease and many oncologists remain reluctant to include surgery within the multimodal treatment strategy of these patients . Although systemic treatments can achieve approximately 60% of responses in breast cancer recurrence, long-term survival is exceptional only with medical treatment . Without liver resection, the average survival reported after the first onset of liver metastases is distributed over a range from 1 to 15 months. Surgery is becoming more functional and effective than conservative treatment in improving the poor outcomes of patients with BCLM . However, there is no generally acknowledged set of standards for identifying candidates who will benefit from surgery. The proper indication for surgical treatment is still a matter of discussion; surgical resection should be assessed when the following premises are met: low surgical risk, low metastasis number, complete macroscopic liver removal, absence of proven extrahepatic disease by positron emission tomography and computed tomography, objective response to chemotherapy before surgery, and long disease-free interval. Breast cancer liver metastasis surgery (BCLMS) is included in an onco-surgical strategy.

Most of the published series of patients with liver metastases of breast cancer who have undergone surgery come from a single center or few centers and there are hardly any long-term results, so we consider necessary to carry out a multicenter review of patients who underwent surgery in high volume centers across Europe belonging to the European-African Hepato-Pancreato-Biliary Association (E-AHPBA) to asses survival and disease-free survival and to determine which patients may benefit from surgery.

This retrospective multicenter cohort study in centers performing BCLMS aims to provide an assessment of the outcomes across E-AHPBA centers.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: July 31, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients = 18 year old.

• Scheduled surgery for breast cancer liver metastases between January 1st 2010 and December 31st 2015

• American Society of Anesthesiologists (ASA) score I-III.

• They have signed the informed consent.

Exclusion Criteria:

• Patients under 18 year old.

• ASA = IV.

• Urgent surgery.

• Patients who have not signed the informed consent.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis
• Neoplasms, Second Primary
• Surgery

Locations

Country	Name	City	State
Spain	Mario Serradilla Martín	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Miguel Servet	Asociación Española de Cirujanos

Country where clinical trial is conducted

Spain, 

References & Publications (15)

Brooke-Smith M, Figueras J, Ullah S, Rees M, Vauthey JN, Hugh TJ, Garden OJ, Fan ST, Crawford M, Makuuchi M, Yokoyama Y, Büchler M, Weitz J, Padbury R. Prospective evaluation of the International Study Group for Liver Surgery definition of bile leak after — View Citation

Chen QF, Huang T, Shen L, Wu P, Huang ZL, Li W. Prognostic factors and survival according to tumor subtype in newly diagnosed breast cancer with liver metastases: A competing risk analysis. Mol Clin Oncol. 2019 Sep;11(3):259-269. doi: 10.3892/mco.2019.189 — View Citation

Díaz R, Santaballa A, Munárriz B, Calderero V. Hepatic resection in breast cancer metastases: should it be considered standard treatment? Breast. 2004 Jun;13(3):254-8. Review. — View Citation

Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. — View Citation

Figueras J, González HD. [Surgical treatment of breast cancer liver metastasis. The great assignment awaiting Spanish hepatic surgery]. Cir Esp. 2008 Nov;84(5):239-40. Spanish. — View Citation

He X, Zhang Q, Feng Y, Li Z, Pan Q, Zhao Y, Zhu W, Zhang N, Zhou J, Wang L, Wang M, Liu Z, Zhu H, Shao Z, Wang L. Resection of liver metastases from breast cancer: a multicentre analysis. Clin Transl Oncol. 2020 Apr;22(4):512-521. doi: 10.1007/s12094-019- — View Citation

Margonis GA, Buettner S, Sasaki K, Kim Y, Ratti F, Russolillo N, Ferrero A, Berger N, Gamblin TC, Poultsides G, Tran T, Postlewait LM, Maithel S, Michaels AD, Bauer TW, Marques H, Barroso E, Aldrighetti L, Pawlik TM. The role of liver-directed surgery in — View Citation

Rahbari NN, Garden OJ, Padbury R, Brooke-Smith M, Crawford M, Adam R, Koch M, Makuuchi M, Dematteo RP, Christophi C, Banting S, Usatoff V, Nagino M, Maddern G, Hugh TJ, Vauthey JN, Greig P, Rees M, Yokoyama Y, Fan ST, Nimura Y, Figueras J, Capussotti L, B — View Citation

Rahbari NN, Garden OJ, Padbury R, Maddern G, Koch M, Hugh TJ, Fan ST, Nimura Y, Figueras J, Vauthey JN, Rees M, Adam R, Dematteo RP, Greig P, Usatoff V, Banting S, Nagino M, Capussotti L, Yokoyama Y, Brooke-Smith M, Crawford M, Christophi C, Makuuchi M, B — View Citation

Ramia JM, Villar J, Villegas T, Muffak K, Garrote D, Ferrón JA. [Surgical treatment of liver metastases from breast cancer]. Cir Esp. 2005 Nov;78(5):318-22. Spanish. — View Citation

Roffman CE, Buchanan J, Allison GT. Charlson Comorbidities Index. J Physiother. 2016 Jul;62(3):171. doi: 10.1016/j.jphys.2016.05.008. Epub 2016 Jun 11. — View Citation

Sadot E, Lee SY, Sofocleous CT, Solomon SB, Gönen 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 Trea — View Citation

Satava RM. Identification and reduction of surgical error using simulation. Minim Invasive Ther Allied Technol. 2005;14(4):257-61. — View Citation

The Royal College of Pathologists. Standards and Minimum Datasets for Reporting Cancers Minimum dataset for the histopathological reporting of pancreatic, ampulla of Vater and bile duct carcinoma. London R Coll Pathol. 2002.

Treska V, Cerna M, Kydlicek T, Treskova I. Prognostic factors of breast cancer liver metastasis surgery. Arch Med Sci. 2015 Jun 19;11(3):683-5. doi: 10.5114/aoms.2015.52376. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival and disease-free survival at 1st year.	Disease-free time and survival at 1st year.	1 year.
Primary	Survival and disease-free survival at 3th year.	Disease-free time and survival at 3th year.	3 years.
Primary	Survival and disease-free survival at 5th year.	Disease-free time and survival at 5th year.	5 years.
Secondary	Preoperative details-Tumor TNM	Stage	5 years.
Secondary	Preoperative details- Dysplasia grade	Low-Moderate- High	5 years.
Secondary	Preoperative details- Tumor subtypes	Yes/No of Luminal A/Luminal B/ HER2+/Triple negative-basal like	5 years.
Secondary	Preoperative details- Location of breast cancer	Breast Quadrant	5 years.
Secondary	Preoperative details- Segment location	Segment 1 to 8	5 years.
Secondary	Preoperative details- Number of liver metastasis	Number	5 years.
Secondary	Intra-operative events	Satava's Classification	Surgery date.
Secondary	Nº metastasis intraoperatively	Number	Surgery date.
Secondary	Post-operative curse- Re-hospitalization cause	Cause of re-hospitalization	30 days.
Secondary	Post-operative curse- Complications	Clavien- Dindo Classification	30 days.
Secondary	Post-operative curse- ICU admission length of stay	Days	30 days.
Secondary	Histopathological details- Ki67	Percent	30 days.
Secondary	Histopathological details- Resection status	R0-R1-R2	30 days.
Secondary	Histopathological details- Nº of lesions	Number	30 days.
Secondary	Follow up- Adjuvant systemic treatment	Yes/No of Chemotherapy, Hormonetherapy, AntiHER2Therapy, Antiangiogenics	5 years.
Secondary	Follow up- Liver metastasis relapse	Location of relapse	5 years.
Secondary	Follow up- Date of death	Date	5 years.