NCT07672743

Brief Summary

For locally advanced or recurrent metastatic breast cancer that is resistant to systemic therapy, radiotherapy (RT) may be considered as the preferred treatment option when the lesion is unresectable, or the patient is not suitable for surgery. This study aim to evelatuate the local control of radical dose RT or new RT technique (such as patially fractionated radiation therapy, SFRT) for the locally advanced or recurrent metastatic breast cancer.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
17mo left

Started Jun 2026

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress6%
Jun 2026Dec 2027

First Submitted

Initial submission to the registry

January 25, 2026

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 29, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

June 30, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

June 29, 2026

Status Verified

January 1, 2026

Enrollment Period

1.5 years

First QC Date

January 25, 2026

Last Update Submit

June 22, 2026

Conditions

Breast Cancer

Keywords

breast cancerradiotherapyspatially fractionated radiation therapy

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate (ORR)

    3 months

Secondary Outcomes (5)

  • Overall Response Rate (ORR)

    1 month

  • Local control

    1 year

  • Progression-Free Survival (PFS)

    1 year

  • Overall Survival (OS)

    1 year

  • Number of participants with treatment-related acute and late adverse events as assessed by CTCAE v5.0

    1 year

Study Arms (1)

Radiotherapy

EXPERIMENTAL

Radical dose is delivered for the patients. . SFRT is recommended for the patients with bulky tumor (such as ≥ 5cm). SFRT is delivered with 12-20Gy (1 fraction) followed by EBRT with EQD2≥60Gy.

Radiation: Radical dose radiotherapy

Interventions

Radical dose radiotherapyRADIATION

Radical dose is delivered for the patients. SFRT is recommended for the patients with bulky tumor (such as ≥ 5cm). SFRT is delivered with 12-20Gy (1 fraction) followed by external beam radiation therapy (EBRT) with EQD2≥60Gy.

Radiotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
  • Locally advanced or recurrent metastatic breast cancer, pathologically confirmed;
  • At least one extracranial measurable lesion suitable for radiotherapy;
  • Signature of informed consent form.

You may not qualify if:

  • Pregnant or lactation women;
  • Severe concomitant conditions, including persistent or active infections, symptomatic congestive heart failure, unstable angina pectoris, and serious arrhythmias et al.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief Physician

Study Record Dates

First Submitted

January 25, 2026

First Posted

June 29, 2026

Study Start

June 30, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

June 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)