This study evaluates whether radiotherapy can safely be omitted in breast cancer patients with T1-2N0 tumors who achieve a pathologic complete response after neoadjuvant systemic therapy and breast-conserving surgery
The proportion of women diagnosed with breast cancer who are treated with neoadjuvant systemic therapy is increasing. Depending on the subtype, 10-75% of these patients will have a pathologic complete response. Currently breast conserving surgery with pathologic complete response is followed by radiotherapy. In this patient group risk of local recurrence is low, but radiotherapy may cause considerable morbidity. The aim of this study is to investigate whether omitting radiotherapy is safe for patients with a node-negative breast tumor \<5cm treated with neoadjuvant systemic therapy and breast conserving surgery who achieve a pathologic complete response
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
595
Omission of radiotherapy
Antoni van Leeuwenhoek
Amsterdam, North Holland, Netherlands
RECRUITINGLocal recurrence
To show that radiotherapy after neoadjuvant systemic therapy and breast-conserving surgery can be omitted in T1-2N0 breast cancer patients who achieve pathologic complete response without compromising the 5 - year local recurrence rate (i.e, \< 6% axillary recurrences within 5 years).
Time frame: 5 years
Level of cancer worry
The patients' experienced level of cancer worry will be measured using the validated 8-item Cancer Worry Scale (i.e., low (Cancer Worry Scale score ≤ 13 at each assessment) and high (Cancer Worry Scale score ≥14 at each assessment)).
Time frame: 4 years
Satisfaction reported by PROM (patient reported outcome measures)
The patients´experienced quality of life and satisfaction will be measured using the validated questionnaire EORTC-QLQ-C30 (Quality of life in cancer patients) and EORTC-QLQ-BR23 (Quality of life of patients with breast cancer)
Time frame: 4 years
Overall survival
Time frame: 5 and 10 years
Disease-specific survival
Time frame: 5 and 10 years
Locoregional recurrence
Time frame: 5 years
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