Actively Recruiting
DESCARTES: De-ESCAlation of RadioTherapy in Patients With Pathologic Complete rESponse to Neoadjuvant Systemic Therapy
Led by The Netherlands Cancer Institute · Updated on 2025-03-26
595
Participants Needed
1
Research Sites
760 weeks
Total Duration
On this page
Sponsors
T
The Netherlands Cancer Institute
Lead Sponsor
D
Dutch Cancer Society
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
DESCARTES: De-ESCAlation of RadioTherapy in Patients With Pathologic Complete rESponse to Neoadjuvant Systemic Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 years or older
- Diagnosed with invasive HR positive/HER2 negative, HER2 positive, or triple-negative breast cancer
- Concurrent DCIS allowed if no extensive component is suspected based on imaging
- Primary tumor clinical stage cT1-2
- Unifocal disease confirmed by pre-treatment imaging
- Clinical nodal stage 0 with no lymph node metastases confirmed by ultrasound or FDG-PET/CT
- Received neoadjuvant systemic treatment
- Marker placed in breast tumor before neoadjuvant therapy
- Breast conserving surgery performed (no mastectomy)
- Sentinel node biopsy performed before or after neoadjuvant therapy
- Pathologic complete response in breast and lymph nodes with no residual tumor or DCIS
- Provided written informed consent
You will not qualify if you...
- Primary tumor clinical stage cT3-4
- Pre- or post-neoadjuvant therapy diagnosis of nodal disease including isolated tumor cells
- No axillary ultrasound or FDG-PET/CT before neoadjuvant therapy
- History of breast cancer or DCIS
- Synchronous contralateral breast cancer or DCIS
- Synchronous metastatic disease (M1)
- Carrier of gene mutations linked to increased breast cancer risk (BRCA1, BRCA2, CHEK2, TP53, PALB-2)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Antoni van Leeuwenhoek
Amsterdam, North Holland, Netherlands, 1066 CX
Actively Recruiting
Research Team
F
F.H. van Duijnhoven, MD, PhD
CONTACT
J
J.P. van Olmen, Drs
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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