An interventional study of Omission of radiotherapy in Breast Cancer, sponsored by The Netherlands Cancer Institute. Recruiting at 1 site in Netherlands. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-26.
Sponsored by The Netherlands Cancer Institute · Not applicable, Interventional, and Treatment
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
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 595 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →The Netherlands Cancer Institute is the lead sponsor of 231 studies on the registry; 67 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Radiation: Omission of radiotherapy
Omission of radiotherapy
Local 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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