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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04817813
Acronym
LIBREAST
Enrollment
300
Registered
2021-03-26
Start date
2021-03-15
Completion date
2021-07-31
Last updated
2021-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Liver Metastases, Surgery

Keywords

Breast cancer, Liver metastases, Hepatic surgery

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.

Interventions

None listed

Sponsors

Spanish Association of Surgeons (AEC)
CollaboratorOTHER
Hospital Miguel Servet
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Survival and disease-free survival at 1st year.1 year.Disease-free time and survival at 1st year.
Survival and disease-free survival at 3th year.3 years.Disease-free time and survival at 3th year.
Survival and disease-free survival at 5th year.5 years.Disease-free time and survival at 5th year.

Secondary

MeasureTime frameDescription
Preoperative details- Location of breast cancer5 years.Breast Quadrant
Preoperative details- Segment location5 years.Segment 1 to 8
Preoperative details- Number of liver metastasis5 years.Number
Intra-operative eventsSurgery date.Satava's Classification
Nº metastasis intraoperativelySurgery date.Number
Post-operative curse- Re-hospitalization cause30 days.Cause of re-hospitalization
Post-operative curse- Complications30 days.Clavien- Dindo Classification
Preoperative details-Tumor TNM5 years.Stage
Histopathological details- Ki6730 days.Percent
Histopathological details- Resection status30 days.R0-R1-R2
Histopathological details- Nº of lesions30 days.Number
Follow up- Adjuvant systemic treatment5 years.Yes/No of Chemotherapy, Hormonetherapy, AntiHER2Therapy, Antiangiogenics
Follow up- Liver metastasis relapse5 years.Location of relapse
Follow up- Date of death5 years.Date
Post-operative curse- ICU admission length of stay30 days.Days
Preoperative details- Dysplasia grade5 years.Low-Moderate- High
Preoperative details- Tumor subtypes5 years.Yes/No of Luminal A/Luminal B/ HER2+/Triple negative-basal like

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026