A Phase II Study of Radiation Therapy to Treat Refractory Breast Cancer

June 22, 2026 updated by: Shulian Wang,MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

A Prospective Phase II Study of Radiation Therapy to Treat Refractory Breast Cancer

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100021
        • Cancer Hospital, Chinese Academy of Medical Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiotherapy
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Response Rate (ORR)
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival (OS)
Time Frame: 1 year
1 year
Progression-Free Survival (PFS)
Time Frame: 1 year
1 year
Overall Response Rate (ORR)
Time Frame: 1 month
1 month
Local control
Time Frame: 1 year
1 year
Number of participants with treatment-related acute and late adverse events as assessed by CTCAE v5.0
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 30, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 25, 2026

First Submitted That Met QC Criteria

June 22, 2026

First Posted (Actual)

June 29, 2026

Study Record Updates

Last Update Posted (Actual)

June 29, 2026

Last Update Submitted That Met QC Criteria

June 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCC5020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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