Radiotherapy for Extracranial Oligometastatic Breast Cancer

Breast Cancer Metastatic Clinical Trial

Official title:

Systemic Therapy With or Without Local Radiotherapy for Extracranial Oligometastatic Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04646564
• Other study ID #: NCC2493
• Status: Recruiting
• Phase: Phase 3
• Start date: April 6, 2021
• Est. completion date: April 30, 2026

Study information

• Verified date: January 2022
• Source: Chinese Academy of Medical Sciences
• Contact: Shu-lian Wang, M.D
• Phone: 8610-87788803
• Email: wangsl[@]cicams.ac.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

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

Related Conditions & MeSH terms

• Breast Cancer Metastatic
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Cancer Hospital, Chinese Academy of Medical Sciences	Beijing	Beijing
China	Wei-Fang Yang	Tai Zhou	Zhejiang

Sponsors (8)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences	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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival	Time from randomization to disease progression at any site or death.	2 years
Secondary	Overall Survival	Time from randomization to death from any cause.	2 years
Secondary	Local control rate	Incidence of tumor control within RT fields during follow up.	2 years
Secondary	Incidence of toxicities	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	2 years
Secondary	Quality of Life measured by the Functional Assessment of Cancer Therapy- General (FACT-G)	Assessment of quality of life scores by FACT-G	2 years
Secondary	Translational exploration	Assessment of circulating tumor cells (CTCs), ctDNA, as prognostic and predictive markers of survival, and for early detection of progression.	2 years
Secondary	Proportion of acceptable SBRT completion	Proportion of patients who completed SBRT with acceptable dose prescriptions	2 years