Trial details

Trial short name: STOMP

Official title: Stereotactic body radiotherapy (SBRT) in the treatment of oligometastatic breast cancer: A phase I feasibility trial

Principal Investigator: Dr. Irene Karam

Cancer type: Breast
Cancer location: Breast
Disease stage: Advanced Cancer
Trial phase: Phase 1
Intervention: Radiation: SBRT

Registration #: NCT03295916

Trial description:
The purpose of this study is to evaluate the feasibility of treating multi-site breast cancer oligometastasis (OM) with stereotactic body radiotherapy (SBRT) in patients with metastatic breast cancer. Thirty patients will be recruited for study participation through the breast and bone metastasis clinic. All participants will receive 2-5 fractions of SBRT treatment to each OM site, delivered every other day, with all treatment completed within two weeks.

Inclusion Criteria: • New diagnosis of metastatic breast cancer within twelve months of registration • Lesions may be synchronous (at diagnosis of breast cancer) or metachronous (following disease-free interval after previous diagnosis of stage I-III breast cancer), as long as primary tumor is treated radically simultaneously with or prior to SBRT for oligometastatic lesions. • Adequate definitive primary treatment including partial or complete mastectomy, standard partial breast, whole breast or loco-regional radiotherapy, with or without hormonal therapy or chemotherapy. • Once diagnosed with metastatic disease (radiologic or pathologic), patients must be offered systemic therapy prior to SBRT. Systemic therapy (including chemotherapy, hormonal therapy, or targeted therapy) may have been initiated within the previous twelve months from registration date, or commence following SBRT. • Total burden of disease limited to 5 metastatic sites or less, and the size of each metastatic lesion must be less than or equal to 5 centimeters; Exclusion Criteria • Previous radiotherapy to same site or vicinity preventing definitive SBRT (eg. within 5 cm) or patients with lesions deemed not amenable to SBRT. • Unacceptable fracture risk according to clinician judgement for bone lesions; • Brain metastasis, spinal cord compression, superior vena cava obstruction; • Bone lesions inside the femoral head/neck; • Patients refusing or deemed ineligible for systemic (chemotherapy, hormonal therapy or targeted therapy) at time of metastatic disease diagnosis; • History of major radiosensitivity syndrome or contraindications to radiotherapy; • Second invasive malignancy within the past 3 years (excluding non-melanomatous skin cancer); • Inability to lie supine for 60 minutes of treatment; • Currently pregnant or lactating; • Psychiatric or addictive disorders precluding informed consent or adherence to protocol; • Performance status ECOG 3 or worse; • Less than 18 years of age. • Systemic cytotoxic chemotherapy and targeted agents must be stopped one week prior to and one week following SBRT. Bisphosphonates and pain medications may be taken during treatment. • Inadequate organ function (in case where liver or kidney within close proximity to treatment field and deemed to be at risk of further radiation induced damage) such that aspartate (AST) or alanine (ALT) aminotransferase >3.0 X upper limit of normal (ULN), Bilirubin > 3.0 X ULN, Creatinine > 3.0 X ULN, alkaline phosphatase > 3 X ULN within 3 months • No radiologic CT or MRI imaging of lesion within the previous 3 months of registration.