Menu
Recruiting NCT05416164

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

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Omission of radiotherapy.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

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

Interventions

  • Radiation Omission of radiotherapy
    Omission of radiotherapy

Primary outcome measures

  • Local recurrence [Time frame: 5 years]
Secondary outcome measures (5)
  • Level of cancer worry [Time frame: 4 years]
  • Satisfaction reported by PROM (patient reported outcome measures) [Time frame: 4 years]
  • Overall survival [Time frame: 5 and 10 years]
  • Disease-specific survival [Time frame: 5 and 10 years]
  • Locoregional recurrence [Time frame: 5 years]

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

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Netherlands · 1 center
  • Antoni van Leeuwenhoek — Amsterdam

Publications

  • van Hemert AKE, van Olmen JP, Boersma LJ, Maduro JH, Russell NS, Tol J, Engelhardt EG, Rutgers EJT, Vrancken Peeters MTFD, van Duijnhoven FH. De-ESCAlating RadioTherapy in breast cancer patients with pathologic complete response to neoadjuvant systemic therapy: DESCARTES study. Breast Cancer Res Treat. 2023 May;199(1):81-89. doi: 10.1007/s10549-023-06899-y. Epub 2023 Mar 9. PMID 36892723

Identifiers

NCT: NCT05416164 · M21CAR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗