RecruitingNot ApplicableNCT05416164
DESCARTES: De-ESCAlation of RadioTherapy in Patients With Pathologic Complete rESponse to Neoadjuvant Systemic Therapy
Sponsor
The Netherlands Cancer Institute
Enrollment
595 participants
Start Date
Oct 7, 2022
Study Type
INTERVENTIONAL
Conditions
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: FEMALEMin Age: 18 Years
Inclusion Criteria12
- 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 Criteria7
- 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
Interventions
RADIATIONOmission of radiotherapy
Omission of radiotherapy
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05416164
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