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Recruiting Not applicable

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

NCT05416164 · tracked via the Priya Life Science Netherlands tracker
Phase
Not applicable
Started
2022-10-07
Last updated
2025-03-26

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Omission of radiotherapy

Omission of radiotherapy: Omission of radiotherapy

Study summary

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

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Local recurrence — 5 years
    To show that radiotherapy after neoadjuvant systemic therapy and breast-conserving surgery can be omitted in T1-2N0 breast cancer patients who achieve pathologic complete response without compromising the 5 - year local recurrence rate (i.e, \< 6% axillary recurrences within 5 years).

Trial sites (1)

FacilityCityRegionStatus
Antoni van Leeuwenhoek Amsterdam North Holland Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05416164 on ClinicalTrials.gov ↗ ← All trials in the Netherlands