A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer

Stereotactic Body Radiation Therapy (SBRT) to Extend the Benefit of Systemic Therapy in Patients With Solitary Disease Progression

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05534438

Enrollment

Registered

2022-09-09

Start date

2022-09-06

Completion date

2026-09-06

Last updated

2026-07-10

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

Conditions

Breast Cancer, ER+ Breast Cancer, HER2+ Breast Cancer, Metastatic Breast Cancer, Metastatic Breast Carcinoma, Oligometastatic Breast Carcinoma

Keywords

oligometastatic breast cancer, breast cancer, ER+ Breast Cancer, HER2+ Breast Cancer, Metastatic Breast Cancer, Stereotactic Body Radiation Therapy, 22-259, Memorial Sloan Kettering Cancer Center

Brief summary

The purpose of this study is to see if using Stereotactic Body Radiation Therapy/SBRT to treat a single metastatic site where cancer has worsened may be an effective treatment for people with oligometastatic breast cancer. Participants will stay on their usual drug therapy while they receive SBRT. This combination of SBRT to a single metastatic site and usual drug therapy may prevent participants' cancer from worsening in other metastatic sites or spreading.

Interventions

RADIATIONStereotactic body radiotherapy

SBRT will be initiated as soon as possible, at not beyond 8 weeks of baseline measurements. Recommended dosing is per department standards for oligometastatic disease (ie, 10 Gy x 3 or 7-8 Gy x 5 fractions daily, excluding weekends and departmental holidays)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Age 18 or older * Willing and able to provide informed consent * Metastatic breast cancer, biopsy proven * ER+/HER2-, defined as \>5% ER+ staining * HER2+ (regardless of ER status), including HER2-low and high expressors * History of at least 6 months, sustained response to systemic therapy (clinically or radiographically defined as complete or stable response without progression) * Isolated site of disease progression on FDG PET scan * Consented to 12-245 * ECOG performance status 0-1

Exclusion criteria

* Pregnancy * Serious medical comorbidity precluding radiation, including connective tissue disorders * Intracranial disease (including previous intracranial involvement) * Previous radiotherapy to the intended treatment site that precludes developing a treatment plan that respects normal tissue tolerances.

Design outcomes

Primary

Measure	Time frame	Description
Progression free survival	3 months from start of SBRT delivery	The primary objective is to assess progression free survival, defined as systemic progression or death, within 3 months from start of Stereotactic Body Radiation Therapy/SBRT delivery.

Countries

United States

Contacts

CONTACTAmy Xu, MD, PhD

xua@mskcc.org646-888-6863

CONTACTAtif Khan, MD

khana7@mskcc.org848-225-6334

PRINCIPAL_INVESTIGATORAmy Xu, MD, PhD

Memorial Sloan Kettering Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026