RecruitingPhase 2NCT05534438

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

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

46 participants

Start Date

Sep 6, 2022

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Metastatic Breast Cancer Metastatic Breast Carcinoma ER+ Breast Cancer Oligometastatic Breast Carcinoma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding highly focused, precisely targeted radiation therapy (stereotactic body radiation therapy, or SBRT) to standard drug therapy can improve outcomes in people with metastatic breast cancer who have been responding well to medication but have one spot of new progression. **You may be eligible if...** - You are 18 or older with metastatic breast cancer (biopsy-confirmed) - Your cancer is either ER+/HER2-negative, or HER2-positive (including HER2-low) - You have had at least 6 months of stable or responding disease on systemic therapy - A PET scan shows only one isolated site of new disease progression - You are in good functional health (ECOG 0–1) **You may NOT be eligible if...** - You are pregnant - You have connective tissue disorders or other serious conditions that make radiation too risky - You have had brain metastases (now or previously) - The site to be treated has been previously irradiated to the point where safe re-treatment is not possible Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)