Clinical trial · Interventional
Study for Using Radiosurgery on Limited Metastases of Breast Cancer
A Phase II Study for Using Radiosurgery on Limited Metastases of Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate whether radiosurgery, along with standard chemotherapy, immunotherapy (the treatment of cancer by modulating the immune system and immune response), or hormonal therapy, affects the quality and length of life. The standard therapy is surgery, radiation therapy, or chemotherapy alone or in any combination. A second purpose of this study is to determine if the levels of a special type of protein (called cytokines) found in the blood are related to the quality of life while on this treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer, Metastatic | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated Stereotactic Body Radiation Therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hypofractionated Stereotactic Body Radiation Therapy
- description
- Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary.
- interventionNames
- Procedure: Hypofractionated Stereotactic Body Radiation Therapy
- Radiation: Hypofractionated Stereotactic Body Radiation Therapy
Primary outcomes (3)
- measure
- Overall Survival
- timeFrame
- 2 years
- description
- The percent of patients that survived from date of enrollment until 2 year follow-up visit.
- measure
- Overall Survival
- timeFrame
- 4 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Age: no limit * Karnofsky performance status (KPS) ≥ 70 * No more than 5 metastatic sites involving one or more different organs (liver, lung or bone). * The size of the lesion must be such that it can be safely treated to sterilizing radiation doses according to the rules in the protocol. * Previously treated lesions are not eligible unless the prescribed dose can be safely delivered. * Concurrent therapy is allowed and recommended. The chemotherapy protocol type and schedule are at the discretion of the medical oncologist. * Informed consent must be obtained. * Pregnancy test must be negative for women of child bearing potential Exclusion Criteria: * Inability of patient to be followed longitudinally as specified by protocol. * Technical inability to achieve required dose based on safe dose constraints required for radiosurgery. * Women who are pregnant or nursing. * Failure to meet requirements in Inclusion Criteria * Contraindications to radiation.
References
Publications (0)
Data not yet available