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

Sponsor

Hospital Miguel Servet (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04817813

Collaborator

Spanish Association of Surgeons (AEC) (Other)

300

Enrollment

Location

4.5

Anticipated Duration (Months)

66.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Liver Metastases Surgery

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 Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Mar 15, 2021

Anticipated Primary Completion Date :

Jun 15, 2021

Anticipated Study Completion Date :

Jul 31, 2021

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.