Radiotherapy for Extracranial Oligometastatic Breast Cancer

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.

Conditions

• Breast Cancer Metastatic

Interventions

DRUG

standard 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.

RADIATION

radiotherapy + 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.

Sponsors & Collaborators

• Liaoning Cancer Hospital & Institute

  collaborator OTHER

• Wuhan University

  collaborator OTHER

• China-Japan Union Hospital, Jilin University

  collaborator OTHER

• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

  collaborator OTHER

• West China Hospital

  collaborator OTHER

• Shanxi Province Cancer Hospital

  collaborator OTHER

• Peking Union Medical College Hospital

  collaborator OTHER

• Chinese Academy of Medical Sciences

  lead OTHER

Principal Investigators

• Shu-lian Wang, M.D · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-06

Primary Completion

2024-04-30

Completion

2026-04-30

Countries

• China

Study Locations