Comparing surgery and medical treatment for breast cancer that has spread to the liver
Surgical or Medical Treatment of Breast Cancer Metastasis: A Multicentre Observational Study
This study is testing whether surgery or just medical treatment works better for people with breast cancer that has spread to the liver.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 720 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Rome, Lazio) |
| Trial ID | NCT06093022 on ClinicalTrials.gov |
What this trial studies
This multicenter observational study aims to compare the effectiveness of liver resection versus medical therapy alone in patients with breast cancer liver metastasis (BCLM). It consists of two phases: a retrospective analysis of patients treated from 1994 to 2018 and an ambispective phase including patients treated from 2018 to 2023. The primary endpoint is to evaluate the 5-year overall survival rates between the two treatment approaches, while secondary endpoints include recurrence rates and post-operative complications. Data will be collected from multiple international centers, focusing on a comprehensive analysis of treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with breast cancer liver metastasis.
Not a fit: Patients who are receiving best supportive care or palliative treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective treatment options for patients with breast cancer liver metastasis, potentially improving survival rates.
How similar studies have performed: While the role of liver resection in BCLM is controversial, similar studies have explored surgical interventions in metastatic cancers, indicating potential for significant findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \> 18 years old * BCLM * BCLM and extra-hepatic disease * Any treatment * Ability to understand and sign the informed consent Exclusion Criteria: * Inability to provide the informed consent * Patient who underwent Best Supportive Care or Palliation
Where this trial is running
Rome, Lazio
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome, Lazio, Italy (Recruiting)
Study contacts
- Study coordinator: Amelia Mattia, MD
- Email: amelia.mattia01@icatt.it
- Phone: +390453015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.