Radiotherapy for Extracranial Oligometastatic Breast Cancer

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer Metastatic
• Intervention / Treatment: Drug: standard of care; Radiation: radiotherapy + standard of care

• Study Type: Interventional
• Enrollment (Anticipated): 170
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Cancer hospital, Chinese Academy of Medical Sciences
  • Zhejiang
    • Tai Zhou, Zhejiang, China
      • Recruiting
      • Wei-Fang Yang
      • Contact: Wei-Fang Yang, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: control arm; standard of care	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.
EXPERIMENTAL: study arm; radiotherapy + standard of care	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival	Time from randomization to disease progression at any site or death.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Time from randomization to death from any cause.	2 years
Local control rate	Incidence of tumor control within RT fields during follow up.	2 years
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
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
Translational exploration	Assessment of circulating tumor cells (CTCs), ctDNA, as prognostic and predictive markers of survival, and for early detection of progression.	2 years
Proportion of acceptable SBRT completion	Proportion of patients who completed SBRT with acceptable dose prescriptions	2 years

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Collaborators: Shanxi Province Cancer Hospital; Wuhan University; Peking Union Medical College Hospital; West China Hospital; Liaoning Tumor Hospital & Institute; China-Japan Union Hospital, Jilin University; Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 6, 2021
• Primary Completion (ANTICIPATED): April 30, 2024
• Study Completion (ANTICIPATED): April 30, 2026

Study Registration Dates

• First Submitted: November 10, 2020
• First Submitted That Met QC Criteria: November 25, 2020
• First Posted (ACTUAL): November 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2022
• Last Update Submitted That Met QC Criteria: January 6, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: radiotherapy; breast neoplasm; stereotactic ablative radiotherapy; oligometastases
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: NCC2493

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No