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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New Jersey
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Commack (Limited Protocol Activities)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
RECRUITING
Harrison
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITING
New York
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
RECRUITING
Uniondale
Pennsylvania
Lehigh Valley Health Network (Data Collection Only)
NOT_YET_RECRUITING
Allentown
Contact Information
Primary
Amy Xu, MD, PhD
xua@mskcc.org
646-888-6863
Backup
Atif Khan, MD
khana7@mskcc.org
848-225-6334
Time Frame
Start Date: 2022-09-06
Estimated Completion Date: 2026-09-06
Participants
Target number of participants: 40
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov