Radiotherapy for Extracranial Oligometastatic Breast Cancer

• Status: Not yet recruiting
• Trial end date: 2023-09-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Collaborators: China-Japan Union Hospital, Jilin University; Liaoning Tumor Hospital & Institute; Peking Union Medical College Hospital; Shanxi Province Cancer Hospital; Taizhou Hospital of Zhejiang Province; West China Hospital; Wuhan University

Criteria

Inclusion Criteria:

• 18-70 years old

• ECOG performance status 0-2.

• Metachronous extracranial oligometastatic diseases which occurred after 3 months after radical surgery, and diagnosed by pathology or imaging. Biopsy of metastasis is preferred.

• Total number of metastases 1-5 , the maximum diameter of metastases ≤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 Criteria:

• Have simultaneous locoregional recurrences.

• 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