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

March 23, 2021 updated by: Mario Serradilla, MD, FACS, Hospital Miguel Servet

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival and disease-free survival at 1st year.
Time Frame: 1 year.
Disease-free time and survival at 1st year.
1 year.
Survival and disease-free survival at 3th year.
Time Frame: 3 years.
Disease-free time and survival at 3th year.
3 years.
Survival and disease-free survival at 5th year.
Time Frame: 5 years.
Disease-free time and survival at 5th year.
5 years.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Miguel Servet

Collaborators

Spanish Association of Surgeons (AEC)

Investigators

  • Principal Investigator: Mario Serradilla Martín, MD FACS, Zaragoza, Spain. Miguel Servet University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

March 15, 2021

Primary Completion (ANTICIPATED)

June 15, 2021

Study Completion (ANTICIPATED)

July 31, 2021

Study Registration Dates

First Submitted

February 5, 2021

First Submitted That Met QC Criteria

March 23, 2021

First Posted (ACTUAL)

March 26, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 26, 2021

Last Update Submitted That Met QC Criteria

March 23, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI20/596

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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