DESCARTES trial: De-ESCAlating RadioTherapy in patients with pathologic complete rESponse to neoadjuvant systemic therapy.

Recruiting

• Conditions: Breast cancer; 10006291; 10006295

• Registration Number: NL-OMON56100
• Lead Sponsor: WA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 595

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 (if
performed) 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 & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the local recurrence rate (LRR) at 5 years.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary determinants are local non-salvageable recurrence free survival,<br /><br>quality of life, regional recurrence rate, distant recurrence free survival,<br /><br>disease-specific survival and overall survival.</p><br>