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

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

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: Omission of radiotherapy

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 response. Currently breast conserving surgery with pathologic complete response is followed by radiotherapy. In this patient group risk of local recurrence is low, but radiotherapy may cause considerable morbidity.

The aim of this study is to investigate whether omitting radiotherapy is safe for patients with a node-negative breast tumor <5cm treated with neoadjuvant systemic therapy and breast conserving surgery who achieve a pathologic complete response

• Study Type: Interventional
• Enrollment (Estimated): 595
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: F.H. van Duijnhoven, MD, PhD; Phone Number: +31(0)20 5126170; Email: f.v.duijnhoven@nki.nl
• Study Contact Backup: Name: J.P. van Olmen, Drs; Phone Number: 020-5129111; Email: j.v.olmen@nki.nl

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1066 CX
      • Recruiting
      • Antoni van Leeuwenhoek
      • Contact: F.H. van Duijnhoven, MD, PhD; Phone Number: +31(0)20 5126170; Email: f.v.duijnhoven@nki.nl
      • Contact: A. Beerthuizen, Drs.; Phone Number: 0205129111; Email: descartes@nki.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Omission of radiotherapy	Radiation: Omission of radiotherapy; Omission of radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local recurrence	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).	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of cancer worry	The patients' experienced level of cancer worry will be measured using the validated 8-item Cancer Worry Scale (i.e., low (Cancer Worry Scale score ≤ 13 at each assessment) and high (Cancer Worry Scale score ≥14 at each assessment)).	4 years
Satisfaction reported by PROM (patient reported outcome measures)	The patients´experienced quality of life and satisfaction will be measured using the validated questionnaire EORTC-QLQ-C30 (Quality of life in cancer patients) and EORTC-QLQ-BR23 (Quality of life of patients with breast cancer)	4 years
Overall survival		5 and 10 years
Disease-specific survival		5 and 10 years
Locoregional recurrence		5 years

Collaborators and Investigators

• Sponsor: The Netherlands Cancer Institute
• Collaborators: Borstkanker Onderzoek Groep; Dutch Cancer Society

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2022
• Primary Completion (Estimated): May 1, 2032
• Study Completion (Estimated): May 1, 2037

Study Registration Dates

• First Submitted: April 19, 2022
• First Submitted That Met QC Criteria: June 8, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Actual): March 26, 2025
• Last Update Submitted That Met QC Criteria: March 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Breast cancer; Radiotherapy; Neoadjuvant Chemotherapy; Complete response
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Progression; Pathologic Complete Response
• Other Study ID Numbers: M21CAR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No