DESCARTES: De-ESCAlation of RadioTherapy in Patients With Pathologic Complete rESponse to Neoadjuvant Systemic Therapy
Recruiting · NCT05416164 · Interventional (participants receive a specific treatment) · Lead sponsor: The Netherlands Cancer Institute
View the official record on ClinicalTrials.gov →Interventions studied
Omission of radiotherapy
What this trial is about
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
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- Antoni van Leeuwenhoek - Amsterdam, North Holland, Netherlands