Omitting radiotherapy for breast cancer patients with complete response to treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety of omitting radiotherapy in breast cancer patients with T1-2N0 tumors who achieve a pathologic complete response after receiving neoadjuvant systemic therapy and undergoing breast-conserving surgery. The research focuses on a growing population of women diagnosed with breast cancer who are treated with neoadjuvant systemic therapy, where a significant percentage may achieve a complete response. By investigating the potential to forgo radiotherapy, the study aims to reduce treatment-related morbidity while maintaining low local recurrence rates in this specific patient group.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Women, aged ≥ 18 years
* Invasive HR positive/Her2 negative, Her2+ (ER/PR +/-) or TN breast cancer
* Concurrent DCIS in pre-NST biopsy is allowed if there is no suspicion of extensive component i.e. absence of non-mass enhancement on pre-NST MRI, contrast-enhanced mammography or breast-specific gamma imaging and/or absence of calcifications on pre-NST mammography
* Primary tumour (T) clinical stage cT1-2
* Unifocal disease; confirmed by pre-NST MRI, contrast-enhanced mammography or breast-specific gamma imaging
* Clinical nodal stage 0; absence of lymph node metastases should be confirmed by ultrasound or FDG-PET/CT
* Neoadjuvant systemic treatment (NST)
* Marker placed in breast tumour prior to NST
* Breast conserving surgery performed, i.e. no mastectomy
* Sentinel node biopsy performed before or after NST
* Pathologic complete response in breast and lymph nodes, i.e. no residual tumour cells or DCIS detected
* Written informed consent

Exclusion Criteria:

* Primary tumour (T) clinical stage cT3-4
* Pre- or post-NST diagnosis of nodal disease including isolated tumour cells
* Patients without axillary ultrasound or FDG-PET/CT pre-NST
* History of breast cancer or DCIS
* Synchronous contralateral breast cancer or DCIS
* Synchronous M1 disease
* Carrier of gene mutation associated with increased risk of breast cancer, i.e. BRCA1, BRCA2, CHEK2, TP53 or PALB-2

Where it's running

• Antoni van Leeuwenhoek
  Amsterdam, North Holland, Netherlands Recruiting

Study contacts

• Study coordinator: F.H. van Duijnhoven, MD, PhD
• Email: f.v.duijnhoven@nki.nl
• Phone: +31(0)20 5126170

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.