NCT04646564

Radiotherapy for Extracranial Oligometastatic Breast Cancer

Systemic Therapy With or Without Local Radiotherapy for Extracranial Oligometastatic Breast Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

More and more evidence suggests that local radiotherapy can improve the outcomes for patients with oligometastatic disease. The purpose of this study is to assess the impact of radiotherapy, compared with standard systemic therapy alone, on survival, local control and toxicities in patients with extracranial oligometastatic breast cancer. Eligible patients are randomized in a 1:2 ratio between the control arm (standard systemic therapy), and the WLRT arm (standard systemic therapy + radiotherapy). Randomization will be stratified by three factors: visceral metastasis (yes vs.no), number of metastases(≤2 vs. \>2), hormone receptor(positive vs. negative). SBRT technique is preferred. During and after radiotherapy, the patients are followed and the efficacy and toxicities of radiotherapy are evaluated.

Conditions

• Breast Cancer Metastatic

Interventions

Type	Name	Description
DRUG	standard of care	patients receive appropriate therapy at the discretion of the treating oncologist, i.e. systemic therapy according to molecular subtypes, including chemotherapy, endocrine therapy, targeted therapy, or immunotherapy.
RADIATION	radiotherapy + standard of care	Patients receive radiotherapy to all known metastases. SBRT technique is preferred, especially for metastases in bone, lung and liver. Conventional RT can be used when SBRT is not appropriate, such as metastasis in mediastinal or contralateral supraclavicular nodal regions. Total doses of 30Gy to 50Gy in 5 fractions for SBRT are recommended depending on the tolerance of adjacent normal tissue. Total dose of 60Gy in 25 fractions is recommended for conventional RT. Patients can receive systemic therapy concurrently with RT at the discretion of treating radiation oncologist. After completion of SBRT to all sites of known metastatic disease, patients will continue standard of care therapy per the treating oncologist.

Timeline

• Start date: 2021-04-06
• Primary completion: 2024-04-30
• Completion: 2026-04-30
• First posted: 2020-11-30
• Last updated: 2022-01-11

Locations

2 sites across 1 country: China