STereotactic Body Radiotherapy (SBRT) for Oligoprogressive Breast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorJuravinski Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Stereotactic body radiotherapy
RadiationStereotactic body radiotherapy in 5 fractions (body) or 2 or 4 fractions (spine) plus continuation of first line systemic therapy
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: Stereotactic body radiotherapy (SBRT) plus continuation of first line systemic therapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of patients with change in systemic therapy
Change in systemic therapy will occur with progression with the following criteria: 1. Progression not amenable to further SBRT, including multifocal (\>3) sites; 2. Progression in lesion not amenable to further SBRT; 3. Rapid progression such that treating medical oncologist believes change in therapy is warranted; 4. Progression in location including, including visceral metastasis, such that treating medical oncologist believes change in therapy is warranted
Time frame
Six monthsSecondary outcomes
1
Progression-free survival
Progression outside radiotherapy field per RECIST 1.1
Time frame
3, 6, 12, 18, and 24 months2
Local progression
Progression within a treated lesion per RECIST 1.1
Time frame
3, 6, 12, 18, and 24 months3
Time to chemotherapy
Initiation of cytotoxic therapy
Time frame
3, 6, 12, 18, and 24 months4
Overall Survival
Proportion of patients alive
Time frame
3, 6, 12, 18, and 24 monthsLocations
Sponsors and contacts
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Juravinski Cancer Center
Lead sponsor
Juravinski Cancer Centre Foundation
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: