NCT05416164

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-conserving surgery

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
595

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
133mo left

Started Oct 2022

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress25%
Oct 2022May 2037

First Submitted

Initial submission to the registry

April 19, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 13, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

October 7, 2022

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2032

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2037

Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

9.6 years

First QC Date

April 19, 2022

Last Update Submit

March 21, 2025

Conditions

Breast Cancer

Keywords

Neoadjuvant ChemotherapyBreast cancerComplete responseRadiotherapy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Level of cancer worry

    4 years

  • Satisfaction reported by PROM (patient reported outcome measures)

    4 years

  • Overall survival

    5 and 10 years

  • Disease-specific survival

    5 and 10 years

  • Locoregional recurrence

    5 years

Study Arms (1)

Omission of radiotherapy

EXPERIMENTAL
Radiation: Omission of radiotherapy

Interventions

Omission of radiotherapyRADIATION

Omission of radiotherapy

Omission of radiotherapy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Antoni van Leeuwenhoek

Amsterdam, North Holland, 1066 CX, Netherlands

RECRUITING

Related Publications (1)

  • 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: 36892723DERIVED

MeSH Terms

Conditions

Breast NeoplasmsPathologic Complete Response

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesDisease ProgressionDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

F.H. van Duijnhoven, MD, PhD

CONTACT

+31(0)20 5126170f.v.duijnhoven@nki.nl

J.P. van Olmen, Drs

CONTACT

020-5129111j.v.olmen@nki.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2022

First Posted

June 13, 2022

Study Start

October 7, 2022

Primary Completion (Estimated)

May 1, 2032

Study Completion (Estimated)

May 1, 2037

Last Updated

March 26, 2025

Record last verified: 2025-03

Locations

NL(1)