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

NCT ID: NCT04817813

Last Updated: 2021-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-03-15
• Study Completion Date: 2021-07-31

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.

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.

Conditions

Breast Cancer; Liver Metastases; Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spanish Association of Surgeons (AEC)

OTHER

Sponsor Role: collaborator

Hospital Miguel Servet

OTHER

Sponsor Role: lead

Responsible Party

Mario Serradilla, MD, FACS

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mario Serradilla Martín, MD FACS

Role: PRINCIPAL_INVESTIGATOR

Zaragoza, Spain. Miguel Servet University Hospital

Locations

Mario Serradilla Martín

Zaragoza, , Spain

Countries

Spain

Facility Contacts

Mario Serradilla Martín, MD FACS

Role: primary

marioserradilla@hotmail.com

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Other Identifiers

PI20/596

Identifier Type: -

Identifier Source: org_study_id