Recruiting
DESCARTES: De-ESCAlation of RadioTherapy in Patients With Pathologic Complete rESponse to Neoadjuvant Systemic Therapy
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
ClinicalTrials.gov IDNCT05416164
PhaseNA
Enrollment595
SponsorThe Netherlands Cancer Institute
Age18 Years and older
SexFEMALE
Conditions studied
Breast Cancer
About this study
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
Interventions
- Radiation: Omission of radiotherapy — Omission of radiotherapy
Primary outcomes
- Local recurrence (5 years)
Eligibility information
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
Study locations
- Antoni van Leeuwenhoek, Amsterdam, North Holland 1066 CX Netherlands
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-14.