STereotactic Body Radiotherapy (SBRT) for Oligoprogressive Breast Cancer
NCT ID: NCT06489821
Last Updated: 2024-07-08
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
NA
Total Enrollment
36 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-09-01
Study Completion Date
2027-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Metastatic Breast Cancer
Oligoprogression
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Stereotactic body radiotherapy (SBRT) plus continuation of first line systemic therapy
SBRT in 5 or 2 (or 4) fractions for body and spine respectively over 2 weeks, while continuing first line systemic therapy
Group Type
EXPERIMENTAL
Stereotactic body radiotherapy
Intervention Type
RADIATION
Stereotactic body radiotherapy in 5 fractions (body) or 2 or 4 fractions (spine) plus continuation of first line systemic therapy
Interventions
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Stereotactic body radiotherapy
Stereotactic body radiotherapy in 5 fractions (body) or 2 or 4 fractions (spine) plus continuation of first line systemic therapy
Intervention Type
RADIATION
Eligibility Criteria
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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
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.
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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Juravinski Cancer Centre Foundation
OTHER
Sponsor Role
collaborator
Juravinski Cancer Center
OTHER
Sponsor Role
lead
Responsible Party
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Elysia Donovan
Radiation Oncologist
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Kyle McGowan
Role: STUDY_DIRECTOR
Juravinski CC
Central Contacts
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References
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Other Identifiers
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STAR-B
Identifier Type: -
Identifier Source: org_study_id
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