NCT04698252

Local Therapy for ER/PR-positive Oligometastatic Breast Cancer

Local Therapy for Hormone Receptor-positive Oligometastatic Breast Cancer - a Phase II Randomized Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Instituto do Cancer do Estado de São Paulo · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Randomized phase 2 trial to evaluate the efficacy of local therapy for oligometastasis from ER/PR-positive breast cancer. The study hypothesis is that local therapy in addition to systemic therapy improves progression-free survival in comparison with systemic therapy alone.

Detailed description

Patients with estrogen receptor/ progesterone receptor-positive oligometastatic breast cancer with disease controlled after at least six months of systemic therapy will be enrolled in the study. Patients will be randomized to receive local therapy for oligometastatic sites in addition to systemic therapy or systemic therapy alone. Local therapy strategies will include surgery, radiotherapy, and radiofrequency ablation.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	Radiotherapy	Radiation therapy for oligometastatic sites
PROCEDURE	Surgery	Surgery for oligometastatic sites
OTHER	Radiofrequency ablation	Radiofrequency ablation for oligometastatic sites

Timeline

• Start date: 2021-04-01
• Primary completion: 2024-04-01
• Completion: 2031-04-01
• First posted: 2021-01-06
• Last updated: 2022-08-08

Locations

1 site across 1 country: Brazil