Cancer
Conditions
Interventions
External beam partial breast irradiation rPBI
Sponsors
University Health Network
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age > 18 years In-breast recurrence or new primary (ductal carcinoma in situ (DCIS) or invasive ductal carcinoma) Tumour 5 years after completion of prior adjuvant whole or partial breast radiotherapy (prior nodal radiotherapy permitted) Clinically node negative Negative margins (no tumour on ink) Recovered from surgery with the incision completely healed and no signs of infection
Exclusion criteria
Exclusion criteria: Multicentric disease (patients with multifocal breast cancer in the same quadrant are eligible)Tumour histology limited to lobular carcinoma only Extensive intraductal component T4 disease Node positive or distant metastatic disease Serious non-malignant disease (cardiovascular, pulmonary, systemic lupus erythematosus, scleroderma), which would preclude radiation treatment Currently pregnant or lactating Presence of an ipsilateral breast implant or pacemaker Unable to commence radiation within 16 weeks of breast-conserving surgery (or last surgical procedure on the breast) or within 12 weeks from last cycle of adjuvant chemotherapy Unable to clearly define the surgical cavity (oncoplastic procedures are permitted provided the tumor bed is well delineated with surgical clips) Psychiatric disorders which would preclude obtaining informed consent or adherence to protocol Grade II or more late skin toxicity from prior radiation evaluated and graded using CTCAE v5.0
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The risk of adverse events (AEs) of breast reirradiation at 1-year with a 1-week ultra-hypofractionated partial breast irradiation regimen. The risk is hypothesized to be 3 toxicity. | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient-reported quality of life associated with treatment. ;The risk of local, regional, and distant recurrence;The location of local recurrence (in-field or out-of-field). ;The financial toxicity associated with treatment. ;Invasive breast cancer free survival, mastectomy free survival, and overall survival. | — |
Countries
Kenya
Contacts
Public ContactKatu Mutungi
Program Navigator
Outcome results
None listed