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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07672743

Enrollment

Registered

2026-06-29

Start date

2026-06-30

Completion date

2027-12-31

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

breast cancer, radiotherapy, spatially fractionated radiation therapy

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.

Interventions

RADIATIONRadical 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Overall Response Rate (ORR)	3 months

Secondary

Measure	Time frame
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 30, 2026