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NCT Number: NCT07672743

A 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location contact

Shu-Lian Wang, MD.

CONTACT

[email protected]

+86-010-87787659

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radical dose radiotherapy

Radiation

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.

Primary outcomes

  1. Overall Response Rate (ORR)

    Time frame: 3 months

Secondary outcomes

  1. Overall Response Rate (ORR)

    Time frame: 1 month

  2. Local control

    Time frame: 1 year

  3. Progression-Free Survival (PFS)

    Time frame: 1 year

  4. Overall Survival (OS)

    Time frame: 1 year

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 29, 2026
Registry last updated
Jun 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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