Status:
NOT_YET_RECRUITING
STereotactic Body Radiotherapy (SBRT) for Oligoprogressive Breast Cancer
Lead Sponsor:
Juravinski Cancer Center
Collaborating Sponsors:
Juravinski Cancer Centre Foundation
Conditions:
Metastatic Breast Cancer
Oligoprogression
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Recent advances in systemic therapy have facilitated improved progression-free survival (PFS) and treatment tolerability in metastatic breast cancer patients (MBC). Oligoprogression (OP) refers to pro...
Eligibility Criteria
Inclusion
- Diagnosis of progressive metastatic breast cancer on first line systemic therapy, including either hormone receptor positive, Her-2 negative (HR+/Her2-) on endocrine therapy + CDK4/6 inhibitor or Her-2 positive (hormone receptor positive or negative /Her2+) on Her2-targeted therapy regimens.
- Progressive disease limited to "oligoprogression", defined as progression of 5 or fewer extra-cranial lesions with otherwise controlled systemic disease on current line of systemic therapy.
- Patients must have previously controlled disease for at least six months on current systemic therapy
- Deemed a candidate for stereotactic body radiotherapy (SBRT) to all OP lesions
Exclusion
- Requires change in systemic therapy line at the time of OP as determined by medical oncologist;
- Progression on 2nd line or subsequent lines of therapy
- Lacks CT or bone scan Imaging within previous 45 days;
- Progression in \>3 sites in the liver or lung;
- Hormone positive disease on endocrine therapy only at time of enrollment;
- Previous radiotherapy to same site or vicinity preventing definitive SBRT (e.g. within 5 cm);
- Lesions deemed not amenable to SBRT due to large size or location;
- Unacceptable fracture risk according to clinician judgement for bone lesions;
- Brain metastasis or Spinal cord compression;
- History of major radiosensitivity syndrome or contraindications to radiotherapy.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06489821
Start Date
September 1 2024
End Date
December 31 2027
Last Update
July 8 2024
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