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Radiotherapy for Extracranial Oligometastatic Breast Cancer

Primary Purpose

Breast Cancer Metastatic

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
standard of care
radiotherapy + standard of care
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer Metastatic focused on measuring breast neoplasm, oligometastases, radiotherapy, stereotactic ablative radiotherapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Hospital, Chinese Academy of Medical SciencesRecruiting
  • Wei-Fang YangRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

control arm

study arm

Arm Description

standard of care

radiotherapy + standard of care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Overall Survival
Time from randomization to death from any cause.
Local control rate
Incidence of tumor control within RT fields during follow up.
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
Quality of Life measured by the Functional Assessment of Cancer Therapy- General (FACT-G)
Assessment of quality of life scores by FACT-G
Translational exploration
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
Proportion of patients who completed SBRT with acceptable dose prescriptions

Full Information

First Posted
November 10, 2020
Last Updated
January 6, 2022
Sponsor
Chinese Academy of Medical Sciences
Collaborators
Liaoning Tumor Hospital & Institute, Wuhan University, China-Japan Union Hospital, Jilin University, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, West China Hospital, Shanxi Province Cancer Hospital, Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04646564
Brief Title
Radiotherapy for Extracranial Oligometastatic Breast Cancer
Official Title
Systemic Therapy With or Without Local Radiotherapy for Extracranial Oligometastatic Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2021 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
Collaborators
Liaoning Tumor Hospital & Institute, Wuhan University, China-Japan Union Hospital, Jilin University, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, West China Hospital, Shanxi Province Cancer Hospital, Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Metastatic
Keywords
breast neoplasm, oligometastases, radiotherapy, stereotactic ablative radiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control arm
Arm Type
Active Comparator
Arm Description
standard of care
Arm Title
study arm
Arm Type
Experimental
Arm Description
radiotherapy + standard of care
Intervention Type
Drug
Intervention Name(s)
standard of care
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
radiotherapy + standard of care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-free Survival
Description
Time from randomization to disease progression at any site or death.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Time from randomization to death from any cause.
Time Frame
2 years
Title
Local control rate
Description
Incidence of tumor control within RT fields during follow up.
Time Frame
2 years
Title
Incidence of toxicities
Description
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
Time Frame
2 years
Title
Quality of Life measured by the Functional Assessment of Cancer Therapy- General (FACT-G)
Description
Assessment of quality of life scores by FACT-G
Time Frame
2 years
Title
Translational exploration
Description
Assessment of circulating tumor cells (CTCs), ctDNA, as prognostic and predictive markers of survival, and for early detection of progression.
Time Frame
2 years
Title
Proportion of acceptable SBRT completion
Description
Proportion of patients who completed SBRT with acceptable dose prescriptions
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shu-lian Wang, M.D
Phone
8610-87788803
Email
wangsl@cicams.ac.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shu-lian Wang, M.D
Organizational Affiliation
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cancer Hospital, Chinese Academy of Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shu-lian Wang, M.D
Phone
8610-87788803
Email
wangsl@cicams.ac.cn
Facility Name
Wei-Fang Yang
City
Tai Zhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei-Fang Yang, M.D.

12. IPD Sharing Statement

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Radiotherapy for Extracranial Oligometastatic Breast Cancer

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