stereotactic body radiotherapy
RadiationStereotactic body radiotherapy in 5 fractions (body) or 2 or 4 fractions (spine) plus continuation of first line systemic therapy
NCT Number: NCT06489821
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Stereotactic body radiotherapy in 5 fractions (body) or 2 or 4 fractions (spine) plus continuation of first line systemic therapy
Time frame: Six months
Change in systemic therapy will occur with progression with the following criteria:
Time frame: 3, 6, 12, 18, and 24 months
Progression outside radiotherapy field per RECIST 1.1
Time frame: 3, 6, 12, 18, and 24 months
Progression within a treated lesion per RECIST 1.1
Time frame: 3, 6, 12, 18, and 24 months
Initiation of cytotoxic therapy
Time frame: 3, 6, 12, 18, and 24 months
Proportion of patients alive
Time frame: 3, 6, 12, 18, and 24 months
common terminology criteria for adverse events 5.0
Contact information is provided by the study sponsor or research team.
Juravinski Cancer Center
Other
STereotactic Body Radiotherapy (SBRT) After oligoprogRession Metastatic Breast Cancer (STAR-B)
Acronym: STAR-B
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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