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

Inclusion Criteria8

years old
ECOG performance status 0-2.
Newly-diagnosed or metachronous extracranial oligometastatic diseases confirmed by pathology or imaging, with or without locoregional disease (biopsy of metastasis is preferred).
Total number of locoregional and metastatic lesions of 1-5 , the maximum diameter of lesions ≤5 cm and at least one lesion could be evaluated by RECIST1.1.
Have received or plan to receive systemic therapy.
All lesions could be safely treated by radiotherapy.
Life expectancy \> 6 months.
Have adequate organ function.

Exclusion Criteria7

Have metastases in the central nervous system.
have indications for palliative radiotherapy to reduce symptoms, such as pain, bleeding, obstruction, and pending fractures caused by the tumor.
Have moderate/severe liver dysfunction (Child Pugh B or C) from liver metastases, .
Malignant pleural effusion
Unable to tolerate radiotherapy due to serious comorbidity
Have received prior radiotherapy for target area
Pregnant or lactating women

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.