Status:
RECRUITING
DESCARTES: De-ESCAlation of RadioTherapy in Patients With Pathologic Complete rESponse to Neoadjuvant Systemic Therapy
Lead Sponsor:
The Netherlands Cancer Institute
Collaborating Sponsors:
Dutch Cancer Society
Borstkanker Onderzoek Groep
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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-co...
Detailed Description
The proportion of women diagnosed with breast cancer who are treated with neoadjuvant systemic therapy is increasing. Depending on the subtype, 10-75% of these patients will have a pathologic complete...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2037
Estimated Enrollment :
595 Patients enrolled
Trial Details
Trial ID
NCT05416164
Start Date
October 7 2022
End Date
May 1 2037
Last Update
March 26 2025
Active Locations (1)
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1
Antoni van Leeuwenhoek
Amsterdam, North Holland, Netherlands, 1066 CX