RecruitingPhase 3NCT04646564

Radiotherapy for Extracranial Oligometastatic Breast Cancer

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

Sponsor

Chinese Academy of Medical Sciences

Enrollment

170 participants

Start Date

Apr 6, 2021

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Metastatic

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether targeted radiation therapy to a small number of cancer spread sites (called oligometastatic disease) can improve outcomes for people with breast cancer that has spread to a limited number of spots outside the brain. **You may be eligible if...** - You are 18–70 years old - You have breast cancer that has spread to 1–5 locations outside the brain, confirmed by biopsy or imaging - Each tumor is no larger than 5 cm - You have received or plan to receive systemic therapy (such as chemotherapy or hormone therapy) - All spread sites can be safely treated with radiation - You have a life expectancy of more than 6 months **You may NOT be eligible if...** - Your cancer has spread to the brain - You need radiation only to relieve symptoms (like pain or bleeding) - You have significant liver disease from liver metastases - You have malignant fluid around the lungs - You are pregnant or breastfeeding - The target area has already been irradiated Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGstandard 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.

RADIATIONradiotherapy + 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.