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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Stereotactic body radiotherapy in 5 fractions (body) or 2 or 4 fractions (spine) plus continuation of first line systemic therapy
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 months
Progression-free survival
Progression outside radiotherapy field per RECIST 1.1
Time frame: 3, 6, 12, 18, and 24 months
Local progression
Progression within a treated lesion per RECIST 1.1
Time frame: 3, 6, 12, 18, and 24 months
Time to chemotherapy
Initiation of cytotoxic therapy
Time frame: 3, 6, 12, 18, and 24 months
Overall Survival
Proportion of patients alive
Time frame: 3, 6, 12, 18, and 24 months
CTCAE Toxicity
common terminology criteria for adverse events 5.0
Time frame: 3, 6, 12, 18, and 24 months
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