Breast CancerNCT05416164
DESCARTES: De-ESCAlation of RadioTherapy in Patients With Pathologic Complete rESponse to Neoadjuvant Systemic Therapy
A study testing Omission of radiotherapy in people with Breast Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Omission of radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 595 participants
- Where
- 1 siteNetherlands
- Study dates
- 7 Oct 2022to May 2037
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Antoni van Leeuwenhoek
Amsterdam, North Holland, 1066 CX
F.H. van Duijnhoven, MD, PhD, +31(0)20 5126170, f.v.duijnhoven@nki.nl
A. Beerthuizen, Drs., 0205129111, descartes@nki.nl
About this study
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
Read the 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
- Conditions
- Breast Cancer
- Being tested
- Omission of radiotherapy
- Keywords
- Neoadjuvant Chemotherapy, Breast cancer, Complete response, Radiotherapy
- Medical subject headings
- Breast Neoplasms, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omission of radiotherapyRadiation
Omission of radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Omission of radiotherapy | Experimental | Not described Receives: Radiation: Omission of radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 years
Secondary outcomes (5)
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)).
Measured: 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)
Measured: 4 years
Overall survival
Measured: 5 and 10 years
Disease-specific survival
Measured: 5 and 10 years
Locoregional recurrence
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start7 Oct 2022
- Primary completionMay 2032 (estimated)
- Study completionMay 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 595 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society, Borstkanker Onderzoek Groep
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416164
- Sponsor's protocol ID
- M21CAR
- Status last verified
- Mar 2025
- First submitted
- 19 Apr 2022
- Last updated
- 26 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 36892723
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DESCARTES: De-ESCAlation of RadioTherapy in Patients With Pathologic Complete rESponse to Neoadjuvant Systemic Therapy
- ClinicalTrials.gov ID
- NCT05416164
- Acronym / sponsor ID
- M21CAR
- Conditions
- Breast Cancer
- Keywords
- Neoadjuvant Chemotherapy, Breast cancer, Complete response, Radiotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 595 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- Dutch Cancer Society, Borstkanker Onderzoek Groep
- Study start
- 7 Oct 2022 (actual)
- Primary completion
- May 2032 (estimated)
- Study completion
- May 2037 (estimated)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omission of radiotherapy | Experimental | Radiation: Omission of radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omission of radiotherapyOmission of radiotherapy | Radiation | Omission of radiotherapy |
Primary outcome
Local recurrence
Time frame: 5 years
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 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Derived from this study: PubMed 36892723van 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omission of radiotherapy in people with Breast Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact F.H. van Duijnhoven, MD, PhD (+31(0)20 5126170, f.v.duijnhoven@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local recurrence (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05416164, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.