Breast Cancer Clinical Trial
Official title:
Stereotactic Body Radiation Therapy (SBRT) to Extend the Benefit of Systemic Therapy in Patients With Solitary Disease Progression
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.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | September 6, 2025 |
| Est. primary completion date | September 6, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Lehigh Valley Health Network (Data Collection Only) | Allentown | Pennsylvania |
| United States | Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | Basking Ridge | New Jersey |
| United States | Memorial Sloan Kettering Commack (Limited Protocol Activities) | Commack | New York |
| United States | Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Harrison | New York |
| United States | Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | Middletown | New Jersey |
| United States | Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Montvale | New Jersey |
| United States | Memorial Sloan Kettering Cancer Center (All Protocol Activities) | New York | New York |
| United States | Memorial Sloan Kettering Nassau (Limited Protocol Activities) | Uniondale | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Memorial Sloan Kettering Cancer Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression free survival | 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. | 3 months from start of SBRT delivery |
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