An interventional study of Preoperative accelerated partial breast irradiation and Breast conserving surgery in Breast Cancer, sponsored by The Netherlands Cancer Institute. Recruiting at 1 site in Netherlands. Open to female participants aged 51 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by The Netherlands Cancer Institute · Not applicable, Interventional, and Treatment
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.
Standard treatment for an ipsilateral breast recurrence is a salvage mastectomy. However, repeat breast conserving therapy, involving breast conserving surgery (BCS) and postoperative re-irradiation, is a feasible alternative for a selected group of patients. In the primary setting, accelerated partial breast irradiation (APBI) is an international accepted treatment for a subset of breast cancer patients. Preoperative APBI (PAPBI) leads to low complication rates, limited fibrosis/induration in a small volume and good to excellent cosmetic results compared with results reported after postoperative APBI.
The aim of this study is to asses the acute toxicity and feasibility of repeat breast conserving therapy with PAPBI followed by BCS in patients aged 51 years or older with ipsilateral recurrent or second primary low-risk breast cancer or DCIS.
Patients undergo PAPBI 5 times (5 x 5.2 Gray). One-two weeks after completion of PAPBI, patients undergo BCS.
Exclusion Criteria:
Patients receive preoperative accelerated partial breast irradiation of the in situ tumor in the breast followed by repeat breast conserving surgery
Radiation: Preoperative accelerated partial breast irradiation · Procedure: Breast conserving surgery · Procedure: Sentinel node procedure · Procedure: Biopsy track removal
Patients will be treated with 5 x 5.2 Gray (Gy) preoperative accelerated partial breast irradiation of the in situ tumor in the breast
Patients will be treated with breast conserving surgery.
Patients will undergo a (repeat) sentinel node procedure.
The 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.
Time frame: 3,5 months
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.
Time frame: 3 months
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.
Time frame: 3,5 months
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.
Time frame: 3,5 months
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.
Time frame: 3,5 months
Cosmetic outcome according to the BCCT.core software program
Cosmetic outcome according to the Breast Cancer Conservative Treatment cosmetic results (BCCT.core) software program. The program returns an overall cosmetic outcome score (excellent, good, fair, or poor) based on the symmetry of the breasts, skin color, and scar visibility.
Time frame: 3,5 months
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The Netherlands Cancer Institute