NCT05416164 DESCARTES: De-ESCAlation of RadioTherapy in Patients With Pathologic Complete rESponse to Neoadjuvant Systemic Therapy
| NCT ID | NCT05416164 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Netherlands Cancer Institute |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 595 participants |
| Start Date | 2022-10-07 |
| Primary Completion | 2032-05 |
Trial Parameters
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Brief 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 Criteria
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: * Prim
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