Radiotherapy for Extracranial Oligometastatic Breast Cancer

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Enrolling; Phase 3

Conditions: Breast Cancer Metastatic

Treatments: Radiation: radiotherapy + standard of care; Drug: standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT04646564

NCC2493

Details and patient eligibility

About

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.

Enrollment: 170 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-70 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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170 participants in 2 patient groups

control arm

Active Comparator group

Description:

standard of care

Treatment:

Drug: standard of care

study arm

Experimental group

Description:

radiotherapy + standard of care

Treatment:

Radiation: radiotherapy + standard of care

Drug: standard of care