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

40 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

Inclusion Criteria9

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 Criteria4

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.

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)