This study evaluates the acute toxicity and feasibility of repeat breast conserving therapy with preoperative accelerated partial breast re-irradiation (PAPBI) in female patients aged 51 years or older with ipsilateral recurrent or second primary low-risk breast cancer or DCIS.
Female patients ≥ 51 years
Ipsilateral breast cancer; recurrence or second primary
Either histologically proven invasive adenocarcinoma (invasive adenocarcinoma with DCIS component is also accepted) or DCIS alone (calcification associated on imaging)
Histologically proven estrogen receptor positive
≥ grade 3 radiotherapy toxicity in the breast after treatment of the primary tumor
Previous boost radiotherapy is not allowed, UNLESS the protocol tumor lies outside of the original boost area
Distant metastases and/or synchronous contralateral invasive or in situ carcinoma
Invasive lobular carcinoma (ILC) or pleiomorphic lobular carcinoma in situ (LCIS)
Single group
Preoperative accelerated partial breast irradiation
RadiationPatients will be treated with 5 x 5.2 Gray (Gy) preoperative accelerated partial breast irradiation of the in situ tumor in the breast
Breast conserving surgery
Procedure/SurgeryPatients will be treated with breast conserving surgery.
Sentinel node procedure
Procedure/SurgeryPatients will undergo a (repeat) sentinel node procedure.
Biopsy track removal
Procedure/SurgeryThe biopsy track will be surgically removed.
Acute post-treatment toxicity
Acute post-treatment toxicity from start of local treatment up to 3 months after end of local treatment, assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Values range form 0 to 5, with 5 being the worst value. At least grade ≥ 2 toxicity is scored as an event.
Fibrosis/induration
Assessment of fibrosis/induration grade at 3 months after end of local treatment, assessed the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Values range form 0 to 5, with 5 being the worst value.
Patient-reported Outcome Measures (PROMS): EORTC Quality of Life Questionnaire (QLQ)-C30
PROMs will be assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire. All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scales represents a high/healthy level of functioning, whilst a high score for the symptom scales represents a high level of symptomatology or problems.
Patient-reported Outcome Measures (PROMS): EORTC QLQ-BR23
PROMs will be assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-BR23 questionnaire. All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scales represents a high/healthy level of functioning, whilst a high score for the symptom scales represents a high level of symptomatology or problems.
Patient-reported Outcome Measures (PROMS): Patient's Questionnaire Cosmesis
PROMs will be assessed using the Patient's Questionnaire Cosmesis, adapted from Sneeuw et al. (1992). Patients score their cosmetic outcome by the following outcomes: very satisfied, satisfied, neutral, unsatisfied and very unsatisfied.
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The Netherlands Cancer Institute
Lead sponsor
Medical Center Haaglanden
Collaborator
Erasmus Medical Center
Collaborator
Albert Schweitzer Hospital
Collaborator
