DESCARTES: De-ESCAlation of RadioTherapy in Patients With Pathologic Complete rESponse to Neoadjuvant Systemic Therapy

Recruiting now · Not applicable

Conditions studied: Breast Cancer

In brief

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

Key facts

Study ID

NCT05416164

Run by

The Netherlands Cancer Institute

People needed

595

Starts

2022-10-07

Expected to finish

2037-05-01

Last updated by the study team

2025-03-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

• Antoni van Leeuwenhoek — Amsterdam, North Holland, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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