NCT06093022

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
720

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress75%
Apr 2018Dec 2028

Study Start

First participant enrolled

April 1, 2018

Completed
5.5 years until next milestone

First Submitted

Initial submission to the registry

October 6, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Expected
Last Updated

November 14, 2023

Status Verified

September 1, 2023

Enrollment Period

6.6 years

First QC Date

October 6, 2023

Last Update Submit

November 13, 2023

Conditions

Breast CancerLiver Metastases

Keywords

breast cancerliver metastasisliver surgery

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

BCLM-surg

BCLM underwent liver resection

BCLM-med

BCLM underwent medical treatment alone

Eligibility Criteria

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

All patient with BCLM underwent liver resection or medical treatment alone.

You may qualify if:

  • \> 18 years old
  • BCLM
  • BCLM and extra-hepatic disease
  • Any treatment
  • Ability to understand and sign the informed consent

You may not qualify if:

  • Inability to provide the informed consent
  • Patient who underwent Best Supportive Care or Palliation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Lazio, 00168, Italy

RECRUITING

Related Publications (15)

  • 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.

    PMID: 19482250BACKGROUND

  • 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.

    PMID: 30846407BACKGROUND

  • 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.

    PMID: 25885919BACKGROUND

  • 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.

    PMID: 31577379BACKGROUND

  • 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.

    PMID: 33433946BACKGROUND

  • 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.

    PMID: 21281746BACKGROUND

  • 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.

    PMID: 28196771BACKGROUND

  • 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.

    PMID: 33675501BACKGROUND

  • 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: 26445472BACKGROUND

  • 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.

    PMID: 29579478BACKGROUND

  • 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.

    PMID: 24126165BACKGROUND

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

    PMID: 12111882BACKGROUND

  • 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.

    PMID: 19472308BACKGROUND

  • 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.

    PMID: 29966490BACKGROUND

  • 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.

    PMID: 25560730BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Amelia Mattia, MD

CONTACT

+390453015amelia.mattia01@icatt.it

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2023

First Posted

October 23, 2023

Study Start

April 1, 2018

Primary Completion

October 31, 2024

Study Completion (Estimated)

December 31, 2028

Last Updated

November 14, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)