NCT04158843

Radical Local vs. Palliative Therapy for Breast Cancer Patientts With Ipsilateral Humerus or Sternum Oligometastasis

A Randomized, Open Label Trial to Evaluate Radical Local Treatment Versus Palliative Treatment for Breast Cancer Patients With Ipsilateral Humerus or Sternum Oligometastasis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 183 (estimated)
• Sponsor: xuexin he · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Randomized, Open Label, Phase III Trial to Evaluate Radical Local Treatment versus Palliative Treatment for Breast Cancer Patients with Primary Ipsilateral Humerus or Sternum Oligometastasis

Detailed description

This is a prospective, randomized, and multicenter study to compare the radical local treatment versus palliative treatment for breast cancer patients with primary ipsilateral humerus or sternum oligometastasis. 183 subjects will be randomized divided into two groups (experimental group and control group) at a ratio of 2 to 1. Control group: Palliative treatment. No radical surgical resection or radiotherapy is performed in this group. But palliative internal fixation or radiotherapy for pain relief is permitted. Moreover, systemic chemotherapy, endocrine therapy and targeted therapy are allowed. Experimental group：Radical local treatment. Radical resection is performed, and the cutting edge is negative, or radical local radiotherapy is feasible (cumulative radiotherapy dose is greater than or equal to 50Gy). Systemic endocrine therapy and targeted therapy are allowed after radical local therapy. However, whether systemic chemotherapy should be used is determined by clinicians according to clinical experience or guidelines.

Conditions

• Breast Cancer
• Oligometastasis

Interventions

Type	Name	Description
PROCEDURE	Radical resection	Radical resection is performed, and the cutting edge is negative.
RADIATION	Radical radiotherapy	Radical local radiotherapy is feasible (cumulative radiotherapy dose is greater than or equal to 50Gy).
OTHER	Palliative treatment	Including palliative internal fixation, radiotherapy, systemic chemotherapy, endocrine therapy or targeted therapy

Timeline

• Start date: 2020-05-09
• Primary completion: 2022-12-31
• Completion: 2026-12-31
• First posted: 2019-11-12
• Last updated: 2020-05-12

Locations

4 sites across 1 country: China