Breast CancerABLATIVE-2NCT05350722
Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients
A study testing Single dose ablative radiotherapy in people with Breast Cancer, run by Amsterdam UMC, location VUmc at 7 sites in 2 countries.
Trial summary
In this ABLATIVE-2 trial, low-risk breast cancer patients will be treated with MRI-guided single dose preoperative partial breast radiotherapy to assess the rate of pathologic complete response after an interval of six to twelve months between radiotherapy and surgery. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Single dose ablative radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 24 Aug 2022to Dec 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- WHO performance scale ≤2.
- Females at least 50 years of age with unifocal cT1N0 breast cancer on mammography, ultrasound and MRI.
- Patients with an indication for chemotherapy or HER2-targeted therapy according to Dutch National Oncoline Guidelines or own hospital protocols are not eligible. Patients with an indication for endocrine therapy are eligible.
- Tumor size as assessed on MRI.
- On tumor biopsy:
- Bloom-Richardson grade 1 or 2.
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- Non-lobular invasive histological type carcinoma.
- LCIS or (non-extensive) DCIS is accepted.
- ER positive tumor receptor.
- HER2 negative tumor.
- Tumor-negative sentinel node (excluding isolated tumor cells).
- Adequate communication and understanding skills of the Dutch language.
Who cannot join
- Legal incapacity.
- BRCA1, BRCA2 or CHEK2 gene mutation.
- Distant metastasis.
- Previous history of breast cancer or DCIS.
- Other type of malignancy within 5 years before breast cancer diagnosis. Patients with adequately treated malignancy longer than 5 years before breast cancer diagnosis are eligible for inclusion.
- For adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin no specific time span to breast cancer diagnosis is required for inclusion.
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- Collagen synthesis disease.
- Signs of extensive DCIS component on histological biopsy or on imaging (e.g. no extensive calcifications on mammography).
- Invasive lobular carcinoma.
- MRI absolute contraindications as defined by the Department of Radiology.
- Nodal involvement with cytological or histological confirmation.
- Indication for treatment with (neo-)adjuvant chemotherapy.
- Non-feasible dosimetric RT plan.
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Desirée van den Bongard, MD, PhD contact
7 sites in 2 countries
Netherlands6 sites, 6 recruiting
- Recruiting
Flevoziekenhuis
Almere Stad
Gwen Diepenhorst, MD PhD, +31368688888, gdiepenhorst@flevoziekenhuis.nl
- Recruiting
Ziekenhuis Amstelland
Amstelveen
Astrid Baan, MD, +31207557000, a.baan@zha.nl
- Recruiting
Amsterdam UMC
Amsterdam
Yasmin Civil, MD, 0031 20 4441484, y.civil@amsterdamumc.nl
- Recruiting
Canisius Wilhelmina Ziekenhuis
Nijmegen
Dominique van Uden, MD PhD, +31243657657, d.vanuden@cwz.nl
- Recruiting
Radboud UMC
Nijmegen
Paulien Westhoff, MD PhD, +31243614505, Paulien.Westhoff@radboudumc.nl
- Recruiting
Zaans Medisch Centrum
Zaandam
Sandra Muller, MD PhD, +31756502911, muller.dr.s@zaansmc.nl
Australia1 site, 1 recruiting
- Not yet recruiting
GenesisCare
Sydney
Gillian Lamoury, MD, +61400415836, Gillian.Lamoury@health.nsw.gov.au
About this study
In this ABLATIVE-2 trial, low-risk breast cancer patients will be treated with MRI-guided single dose preoperative partial breast radiotherapy to assess the rate of pathologic complete response after an interval of six to twelve months between radiotherapy and surgery. Response monitoring will be assessed using MRI and markers in blood and tumor tissue to enable prediction of pathologic response.
Read the detailed description
Patients will receive single-dose preoperative radiotherapy followed by breast conserving surgery (BCS) at 12 months after radiotherapy, as long as follow-up MRI scans show a complete radiologic response. In case of incomplete radiologic response, BCS will be performed at 6 months after radiotherapy. BCS is performed earlier when progressive disease is found on MRI. In the follow-up period between radiotherapy and surgery, tumor response will be monitored using MRI every 3 months. After surgery, patients will be followed up until 10 years after radiotherapy treatment to assess oncological outcomes, toxicity, cosmetic outcome and quality of life.
- Conditions
- Breast Cancer
- Being tested
- Single dose ablative radiotherapy
- Keywords
- Low-risk breast cancer, Early stage breast cancer, Pre-operative radiotherapy, Partial breast irradiation, Pre-operative single dose radiation, pathologic complete response, cosmetic outcome, survival, toxicity, quality of life, neo-adjuvant radiotherapy, oncological outcomes
- 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.
Single dose ablative radiotherapyRadiation
Patients will receive a single dose of 20Gy/15Gy on the gross tumor volume and clinical tumor volume respectively, in the context of pre-operative partial breast irradiation
| Study group | Role | What they receive |
|---|---|---|
| Pre-operative single dose partial breast irradiation | Experimental | Not described Receives: Radiation: Single dose ablative radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response
pCR is defined as the absence of residual invasive cancer on resected breast specimen
Measured: 12 months after radiotherapy
Secondary outcomes (12)
Radiologic complete response
Radiologic complete response (rCR) is defined as complete absence of pathologic contrast enhancement in the original tumor bed and complete absence of pathologic ADC (apparent diffusion coefficient) reduction in the original tumor bed. rCR is reported according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines.
Measured: at baseline, 2 weeks, 3, 6, 9, and 12 months after radiotherapy
Treatment-related adverse events
Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria Adverse Events version 5.0
Measured: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
Patient quality of life
PROMs are assessed using the European Organization for Research and Treatment of Cancer core-30 quality of life questionnaire (EORTC QLQ-C30)
Measured: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
Breast cancer specific quality of life
PROMs are assessed using the European Organization for Research and Treatment of Cancer breast cancer-specific quality of life questionnaire (EORTC QLQ-BR23)
Measured: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
Patient distress
PROMs are assessed using the Hospital Anxiety and Depression Scale (HADS) questionnaire
Measured: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
Physician reported cosmetic outcome
Cosmetic outcome is assessed by the physician using a questionnaire
Measured: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
Patient reported cosmetic outcome
Cosmetic outcome is assessed by the patient using the BREAST-Q questionnaire. .
Measured: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
Objective cosmetic outcome
Cosmetic outcome is assessed objectively using images captured using the VECTRA XT 3D-imaging system. This three-dimensional surface-imaging system uses stereophotogrammetry to estimate x, y, z coordinates of the imaged surface. These coordinates will be used to calculate the volume-shape-symmetry measure.
Measured: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
Local, regional and distant relapse rates
A local recurrence is defined as disease occurrence in the ipsilateral breast. A regional recurrence is defined as nodal occurrence in the ipsilateral axilla, internal mammary, infraclavicular or supraclavicular region. A distant metastasis defined as disease occurrence in the contralateral breast or contralateral breast nodal region or another organ than breast involvement.
Measured: Day of radiotherapy till end of follow-up of 10 years
Overall survival
Overall survival will be calculated from the date of the radiotherapy treatment until the time of breast-cancer related death or breast-cancer unrelated death.
Measured: Day of radiotherapy till end of follow-up of 10 years
Radiotherapy-associated immune response markers
Immune response markers as CD3, CD4, CD8 and FOXP3 will be assessed in tumor tissue after surgery.
Measured: 12 months after radiotherapy
Radiotherapy-associated biomarkers
ctDNA will be assessed in blood samples taken between radiotherapy and surgery.
Measured: at baseline, 2 weeks, 3, 6, 9, and 12 months after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start24 Aug 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 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.
- 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society
- Responsible party
- Principal investigator, Desiree H.J.G.D. van den Bongard, MD Ph, Amsterdam UMC, location VUmc
- Investigators
- Desirée van den Bongard, MD, PhD, Principal investigator, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350722
- Sponsor's protocol ID
- NL77000.029.21
- Acronym
- ABLATIVE-2
- Status last verified
- Jul 2026
- First submitted
- 14 Mar 2022
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Civil YA, Oei AL, Duvivier KM, Bijker N, Meijnen P, Donkers L, Verheijen S, van Kesteren Z, Palacios MA, Schijf LJ, Barbe E, Konings IRHM, -van der Houven van Oordt CWM, Westhoff PG, Meijer HJM, Diepenhorst GMP, Thijssen V, Mouliere F, Slotman BJ, van der Velde S, van den Bongard HJGD. Prediction of pathologic complete response after single-dose MR-guided partial breast irradiation in low-risk breast cancer patients: the ABLATIVE-2 trial-a study protocol. BMC Cancer. 2023 May 9;23(1):419. doi: 10.1186/s12885-023-10910-6.
PubMed 37161377
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05350722
- Acronym / sponsor ID
- ABLATIVE-2 / NL77000.029.21
- Conditions
- Breast Cancer
- Keywords
- Low-risk breast cancer, Early stage breast cancer, Pre-operative radiotherapy, Partial breast irradiation, Pre-operative single dose radiation, pathologic complete response, cosmetic outcome, survival
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- Dutch Cancer Society
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2037 (estimated)
- First posted
- 28 Apr 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.
In this ABLATIVE-2 trial, low-risk breast cancer patients will be treated with MRI-guided single dose preoperative partial breast radiotherapy to assess the rate of pathologic complete response after an interval of six to twelve months between radiotherapy and surgery. Response monitoring will be assessed using MRI and markers in blood and tumor tissue to enable prediction of pathologic response.
Detailed description
Patients will receive single-dose preoperative radiotherapy followed by breast conserving surgery (BCS) at 12 months after radiotherapy, as long as follow-up MRI scans show a complete radiologic response. In case of incomplete radiologic response, BCS will be performed at 6 months after radiotherapy. BCS is performed earlier when progressive disease is found on MRI. In the follow-up period between radiotherapy and surgery, tumor response will be monitored using MRI every 3 months. After surgery, patients will be followed up until 10 years after radiotherapy treatment to assess oncological outcomes, toxicity, cosmetic outcome and quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pre-operative single dose partial breast irradiation | Experimental | Radiation: Single dose ablative radiotherapy |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- WHO performance scale ≤2.
- Females at least 50 years of age with unifocal cT1N0 breast cancer on mammography, ultrasound and MRI.
- On tumor biopsy:
- Tumor-negative sentinel node (excluding isolated tumor cells).
- Adequate communication and understanding skills of the Dutch language.
Key exclusion criteria (13 listed)
- Legal incapacity.
- BRCA1, BRCA2 or CHEK2 gene mutation.
- Distant metastasis.
- Previous history of breast cancer or DCIS.
- Other type of malignancy within 5 years before breast cancer diagnosis. Patients with adequately treated malignancy longer than 5 years before breast cancer diagnosis are eligible for inclusion.
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 |
|---|---|---|
| Single dose ablative radiotherapyPatients will receive a single dose of 20Gy/15Gy on the gross tumor volume and clinical tumor volume respectively, in the context of pre-operative partial breast irradiation | Radiation | Pre-operative single dose partial breast irradiation |
Primary outcome
Pathologic complete response
Time frame: 12 months after radiotherapy
pCR is defined as the absence of residual invasive cancer on resected breast specimen
12 secondary outcomes
Radiologic complete response
Time frame: at baseline, 2 weeks, 3, 6, 9, and 12 months after radiotherapy
Treatment-related adverse events
Time frame: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
Patient quality of life
Time frame: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
Breast cancer specific quality of life
Time frame: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
Patient distress
Time frame: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
Physician reported cosmetic outcome
Time frame: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
Patient reported cosmetic outcome
Time frame: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
Objective cosmetic outcome
Time frame: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
Local, regional and distant relapse rates
Time frame: Day of radiotherapy till end of follow-up of 10 years
Overall survival
Time frame: Day of radiotherapy till end of follow-up of 10 years
Radiotherapy-associated immune response markers
Time frame: 12 months after radiotherapy
Radiotherapy-associated biomarkers
Time frame: at baseline, 2 weeks, 3, 6, 9, and 12 months after radiotherapy
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 16 Jul 2026.
- Derived from this study: PubMed 37161377Civil YA, Oei AL, Duvivier KM, Bijker N, Meijnen P, Donkers L, Verheijen S, van Kesteren Z, Palacios MA, Schijf LJ, Barbe E, Konings IRHM, -van der Houven van Oordt CWM, Westhoff PG, Meijer HJM, Diepenhorst GMP, Thijssen V, Mouliere F, Slotman BJ, van der Velde S, van den Bongard HJGD. Prediction of pathologic complete response after single-dose MR-guided partial breast irradiation in low-risk breast cancer patients: the ABLATIVE-2 trial-a study protocol. BMC Cancer. 2023 May 9;23(1):419. doi: 10.1186/s12885-023-10910-6.
- Individual participant dataSharing planned: No
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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.
Desirée van den Bongard, MD, PhD contact
Desirée van den Bongard, MD, PhD principal investigator
Amsterdam UMC, location VUmc
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single dose ablative radiotherapy in people with Breast Cancer, run by Amsterdam UMC, location VUmc at 7 sites in 2 countries.
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 13 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 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Netherlands, Australia. 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 Janneke van Roij, MD (+31 6 11094077, j.s.vanroij@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response (time frame: 12 months after radiotherapy). 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 NCT05350722, 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 16 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.