Stereotactic Body Radiation Therapy (SBRT) to Extend the Benefit of Systemic Therapy in Patients With Solitary Disease Progression
Overview
- Phase
- Phase 2
- Intervention
- Stereotactic body radiotherapy
- Conditions
- Oligometastatic Breast Carcinoma
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 46
- Locations
- 16
- Primary Endpoint
- Progression free survival
- Status
- Recruiting
- Last Updated
- 16 days ago
Overview
Brief 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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
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.
Intervention: Stereotactic body radiotherapy
Outcomes
Primary Outcomes
Progression free survival
Time Frame: 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.