Clinical trial NCT04646564: Radiotherapy for Extracranial Oligometastatic Breast Cancer
Official title: Systemic Therapy With or Without Local Radiotherapy for Extracranial Oligometastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Breast Cancer Metastatic
Keywords: breast neoplasm
oligometastases
radiotherapy
stereotactic ablative radiotherapy
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: Liaoning Cancer Hospital & Institute
name: Wuhan University
name: China-Japan Union Hospital, Jilin University
name: Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
name: West China Hospital
name: Shanxi Province Cancer Hospital
name: Peking Union Medical College Hospital
First posted: 2020-11-30
Enrollment: 170
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Progression-free Survival
timeFrame: 2 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 2 years
measure: Local control rate
timeFrame: 2 years
measure: Incidence of toxicities
timeFrame: 2 years
measure: Quality of Life measured by the Functional Assessment of Cancer Therapy- General (FACT-G)
timeFrame: 2 years
measure: Translational exploration
timeFrame: 2 years
measure: Proportion of acceptable SBRT completion
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Tai Zhou
country: China
facility: Wei-Fang Yang
state: Zhejiang
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Shu-lian Wang, M.D
role: PRINCIPAL_INVESTIGATOR
References: