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.
Arms and Interventions
|Experimental: Participants with oligometastatic breast cancer
Participants with oligometastatic breast cancer with isolated progression after sustained (>=6 month) response to systemic therapy. Participants will receive image guided, SBRT to the progressive lesion identified on imaging. Participants will be maintained on their existing line of systemic therapy. Systemic therapy will be held during days of radiation and resume following completion of radiation.
Radiation: Stereotactic 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)
Primary Outcome Measures
- 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.
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
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.
Contacts and Locations
|1||Memoral Sloan Kettering Basking Ridge (Limited Protocol Activities)||Basking Ridge||New Jersey||United States||10065|
|2||Memorial Sloan Kettering Monmouth (Limited Protocol Activities)||Middletown||New Jersey||United States||07748|
|3||Memorial Sloan Kettering Bergen (Limited Protocol Activities)||Montvale||New Jersey||United States||07645|
|4||Memorial Sloan Kettering Commack (Limited Protocol Activities)||Commack||New York||United States||11725|
|5||Memorial Sloan Kettering Westchester (Limited Protocol Activities)||Harrison||New York||United States||10604|
|6||Memorial Sloan Kettering Cancer Center (All Protocol Activities)||New York||New York||United States||10065|
|7||Memorial Sloan Kettering Nassau (Limited Protocol Activities)||Uniondale||New York||United States||11553|
Sponsors and Collaborators
- Memorial Sloan Kettering Cancer Center
- Principal Investigator: Amy Xu, MD, PhD, Memorial Sloan Kettering Cancer Center
Study Documents (Full-Text)None provided.