Radiotherapy for Extracranial Oligometastatic Breast Cancer

Phase 3

Recruiting

Interventions: Drug: standard of care
Radiation: radiotherapy + standard of care

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
control arm	standard of care	standard of care
study arm	standard of care	radiotherapy + standard of care
study arm	radiotherapy + standard of care	radiotherapy + standard of care

Primary Outcome Measures

Name	Time	Method
Progression-free Survival	2 years	Time from randomization to disease progression at any site or death.

Secondary Outcome Measures

Name	Time	Method
Overall Survival	2 years	Time from randomization to death from any cause.
Local control rate	2 years	Incidence of tumor control within RT fields during follow up.
Incidence of toxicities	2 years	Incidence of acute and late toxicities from treatment graded according to radiation therapy oncology group (RTOG) radiation injury criteria and National Cancer Institute CTCAE version 4.0
Quality of Life measured by the Functional Assessment of Cancer Therapy- General (FACT-G)	2 years	Assessment of quality of life scores by FACT-G
Translational exploration	2 years	Assessment of circulating tumor cells (CTCs), ctDNA, as prognostic and predictive markers of survival, and for early detection of progression.
Proportion of acceptable SBRT completion	2 years	Proportion of patients who completed SBRT with acceptable dose prescriptions

Locations (2): Cancer Hospital, Chinese Academy of Medical Sciences
🇨🇳
Beijing, Beijing, China
Wei-Fang Yang
🇨🇳
Tai Zhou, Zhejiang, China

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