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Trial Title:
STereotactic Body Radiotherapy (SBRT) for Oligoprogressive Breast Cancer
NCT ID:
NCT06489821
Condition:
Metastatic Breast Cancer
Oligoprogression
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Stereotactic body radiotherapy
Description:
Stereotactic body radiotherapy in 5 fractions (body) or 2 or 4 fractions (spine) plus
continuation of first line systemic therapy
Arm group label:
Stereotactic body radiotherapy (SBRT) plus continuation of first line systemic therapy
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 progression limited to five or fewer sites in otherwise
controlled systemic disease on a drug therapy. Stereotactic body radiotherapy (SBRT) has
the potential to locally ablate resistant OP lesions that develop on a systemic
treatment, and may consequently delay the need for change in drug therapy, delay time to
chemotherapy and prolong PFS. This is a phase II trial of SBRT plus continuation of
current systemic therapy line for OP MBC patients, to determine rate of delay of change
in systemic therapy of at six months. PFS, time to chemotherapy and quality of life will
also be assessed.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. 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.
2. 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.
3. Patients must have previously controlled disease for at least six months on current
systemic therapy
4. Deemed a candidate for stereotactic body radiotherapy (SBRT) to all OP lesions
Exclusion Criteria:
1. Requires change in systemic therapy line at the time of OP as determined by medical
oncologist;
2. Progression on 2nd line or subsequent lines of therapy
3. Lacks CT or bone scan Imaging within previous 45 days;
4. Progression in >3 sites in the liver or lung;
5. Hormone positive disease on endocrine therapy only at time of enrollment;
6. Previous radiotherapy to same site or vicinity preventing definitive SBRT (e.g.
within 5 cm);
7. Lesions deemed not amenable to SBRT due to large size or location;
8. Unacceptable fracture risk according to clinician judgement for bone lesions;
9. Brain metastasis or Spinal cord compression;
10. History of major radiosensitivity syndrome or contraindications to radiotherapy.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
September 1, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Juravinski Cancer Center
Agency class:
Other
Collaborator:
Agency:
Juravinski Cancer Centre Foundation
Agency class:
Other
Source:
Juravinski Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06489821
