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

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.

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Key information

Conditions

Oligometastatic Breast Carcinoma Breast Cancer Breast Diseases Breast Neoplasms ER+ Breast Cancer HER2+ Breast Cancer Metastatic Breast Cancer Metastatic Breast Carcinoma Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

stereotactic body radiotherapy

Radiation

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)

Other names: SBRT

Primary outcomes

Progression free survival

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amy Xu, MD, PhD

CONTACT

[email protected]

646-888-6863

Atif Khan, MD

CONTACT

[email protected]

848-225-6334

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2026
Study completion: 2026
First posted: Sep 9, 2022
Registry last updated: Jul 10, 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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