NCT04817813

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

March 15, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

March 26, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

February 5, 2021

Last Update Submit

March 23, 2021

Conditions

Breast CancerLiver MetastasesSurgery

Keywords

Breast cancerLiver metastasesHepatic surgery

Outcome Measures

Primary Outcomes (3)

  • Survival and disease-free survival at 1st year.

    Disease-free time and survival at 1st year.

    1 year.

  • Survival and disease-free survival at 3th year.

    Disease-free time and survival at 3th year.

    3 years.

  • Survival and disease-free survival at 5th year.

    Disease-free time and survival at 5th year.

    5 years.

Secondary Outcomes (17)

  • Preoperative details-Tumor TNM

    5 years.

  • Preoperative details- Dysplasia grade

    5 years.

  • Preoperative details- Tumor subtypes

    5 years.

  • Preoperative details- Location of breast cancer

    5 years.

  • Preoperative details- Segment location

    5 years.

  • +12 more secondary outcomes

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients operated on in the participating European centers with breast cancer liver metastases during the study period (between January 1st 2010 and December 31st 2015) and that meet the inclusion criteria.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients under 18 year old.
  • ASA ≥ IV.
  • Urgent surgery.
  • Patients who have not signed the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mario Serradilla Martín

Zaragoza, 50008, Spain

Location

Related Publications (16)

  • 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/s12094-019-02155-2. Epub 2019 Jun 22.

    PMID: 31230220RESULT

  • 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.2019.1890. Epub 2019 Jul 1.

    PMID: 31396386RESULT

  • 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.

    PMID: 26445472RESULT

  • 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 patients with hepatic metastasis from primary breast cancer: a multi-institutional analysis. HPB (Oxford). 2016 Aug;18(8):700-5. doi: 10.1016/j.hpb.2016.05.014. Epub 2016 Jun 29.

    PMID: 27485066RESULT

  • 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. No abstract available.

    PMID: 26170865RESULT

  • Diaz R, Santaballa A, Munarriz B, Calderero V. Hepatic resection in breast cancer metastases: should it be considered standard treatment? Breast. 2004 Jun;13(3):254-8. doi: 10.1016/j.breast.2003.11.001.

    PMID: 15177433RESULT

  • Ramia JM, Villar J, Villegas T, Muffak K, Garrote D, Ferron JA. [Surgical treatment of liver metastases from breast cancer]. Cir Esp. 2005 Nov;78(5):318-22. doi: 10.1016/s0009-739x(05)70942-8. Spanish.

    PMID: 16420849RESULT

  • Figueras J, Gonzalez HD. [Surgical treatment of breast cancer liver metastasis. The great assignment awaiting Spanish hepatic surgery]. Cir Esp. 2008 Nov;84(5):239-40. doi: 10.1016/s0009-739x(08)75913-x. No abstract available. Spanish.

    PMID: 19080906RESULT

  • 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. No abstract available.

    PMID: 27298055RESULT

  • Satava RM. Identification and reduction of surgical error using simulation. Minim Invasive Ther Allied Technol. 2005;14(4):257-61. doi: 10.1080/13645700500274112.

    PMID: 16754172RESULT

  • 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. doi: 10.1097/01.sla.0000133083.54934.ae.

    PMID: 15273542RESULT

  • 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.

    RESULT

  • 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, Buchler MW, Weitz J. Post-hepatectomy haemorrhage: a definition and grading by the International Study Group of Liver Surgery (ISGLS). HPB (Oxford). 2011 Aug;13(8):528-35. doi: 10.1111/j.1477-2574.2011.00319.x. Epub 2011 Jun 7.

    PMID: 21762295RESULT

  • Brooke-Smith M, Figueras J, Ullah S, Rees M, Vauthey JN, Hugh TJ, Garden OJ, Fan ST, Crawford M, Makuuchi M, Yokoyama Y, Buchler M, Weitz J, Padbury R. Prospective evaluation of the International Study Group for Liver Surgery definition of bile leak after a liver resection and the role of routine operative drainage: an international multicentre study. HPB (Oxford). 2015 Jan;17(1):46-51. doi: 10.1111/hpb.12322. Epub 2014 Jul 24.

    PMID: 25059275RESULT

  • 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, Buchler MW, Weitz J. Posthepatectomy liver failure: a definition and grading by the International Study Group of Liver Surgery (ISGLS). Surgery. 2011 May;149(5):713-24. doi: 10.1016/j.surg.2010.10.001. Epub 2011 Jan 14.

    PMID: 21236455RESULT

  • Cantalejo-Diaz M, Ramia JM, Alvarez-Busto I, Kokas B, Blanco-Fernandez G, Munoz-Forner E, Olah A, Montalva-Oron E, Lopez-Lopez V, Rotellar F, Eker H, Rijken A, Prieto-Calvo M, Romano F, Melgar P, Machairas N, Demirli Atici S, Castro-Santiago MJ, Lesurtel M, Skalski M, Bayhan H, Domingo-Del-Pozo C, Hahn O, de Armas-Conde N, Bauza-Collado M, Serradilla-Martin M; Scientific & Research Committee of the E-AHPBA. Long-term outcomes after breast cancer liver metastasis surgery: A European, retrospective, snapshot study (LIBREAST STUDY). Surg Oncol. 2024 Dec;57:102129. doi: 10.1016/j.suronc.2024.102129. Epub 2024 Sep 5.

    PMID: 39243418DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Mario Serradilla Martín, MD FACS

    Zaragoza, Spain. Miguel Servet University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 5, 2021

First Posted

March 26, 2021

Study Start

March 15, 2021

Primary Completion

June 15, 2021

Study Completion

July 31, 2021

Last Updated

March 26, 2021

Record last verified: 2021-03

Locations

ES(1)