SABR PRIMER - Evaluating Stereotactic Ablative Radiotherapy for Primary and Regional Breast Tumors
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBritish Columbia Cancer Agency
About this trial
The study is being done to determine if stereotactic ablative radiotherapy (SABR) can control tumour growth for patients with metastatic breast cancer.
Secondary objectives will be overall survival, progression-free survival and time to switch of next line of systemic therapy.
Radiation-related adverse events will be assess, with a specific focus on dermatitis, lymphedema and brachial plexopathy.
The exploratory objective is to correlate toxicities and outcomes with peripheral blood biomarkers and circulating tumor DNA to potentially help predict responses in future patients receiving combined therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pathologically confirmed AJCC 7th/8th edition Stage IV invasive ductal carcinoma or invasive lobular carcinoma of the breast.
Measurable disease in the breast, suitable to receive radiotherapy.
Receiving or planned to receive systemic therapy.
Patients are allowed to have SABR for oligometastatic disease as clinically indicated
Disqualifiers
Contraindications to radiotherapy, including a history of SLE, systemic scleroderma, IPF, ataxia telangiectasia, pregnancy
Previous history of locoregional radiotherapy to the ipsilateral breast
Trial design
Design model
Single group
Treatments tested in this trial
SABR
RadiationPrescription dose/fractionation: 26Gy/5 with 40Gy/5 +/- 35Gy/5 Boost Radiation Technique: VMAT Treatment Frequency: Every other day (EOD)
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: TreatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Locoregional Control
Assess median, 1-year and 2-year locoregional control
Time frame
2 YearsSecondary outcomes
1
Overall survival
Assess median, 1-year and 2-year overall survival
Time frame
2 Years2
Progression Free Survival
Assess median, 1-year and 2-year progression-free survival
Time frame
2 Years3
systemic therapy switch
Assess median time to systemic therapy switch
Time frame
2 Years4
Adverse Events
Assess radiation-related adverse events using CTCAE v5.0
Time frame
2 YearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: