Breast NeoplasmABLATIVENCT02316561
Single Dose Ablative Radiation Treatment for Early-Stage Breast Cancer
A study testing Single dose ablative radiotherapy in people with Breast Neoplasm, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
The purpose of the study is to investigate the feasibility of a preoperative, single dose, ablative partial breast radiation treatment in patients with early-stage breast cancer. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Neoplasm
- 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
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2014to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 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 or females at least 70 years of age with an unifocal cT1-2(maximum 3 cm)N0 breast cancer:
- Tumor size as assessed on MRI
- On tumor biopsy:
- Non-lobular invasive histological type carcinoma.
- LCIS is accepted.
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- ER positive tumor receptor.
- Tumor negative sentinel node.
- Adequate communication and understanding skills of the Dutch language.
Who cannot join
- Legal incapacity
- Indication for chemotherapy or immunotherapy (i.e. patients with an indication for endocrine therapy are eligible)
- BRCA gene mutation.
- Previous history of breast cancer
- Other type of malignancy within 5 years before breast cancer diagnosis. For adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin no specific time span from breast cancer diagnosis is required for inclusion
- Her2neu positive tumor.
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- Previous history of ipsilateral breast surgery and impaired cosmetic outcome, as assessed by the treating surgeon or radiation-oncologist.
- Collagen synthesis disease.
- Signs of extensive DCIS component on histological biopsy or mammogram.
- Invasive lobular carcinoma.
- MRI absolute contraindications as defined by the Radiology Department.
- Nodal involvement with cytological or histological confirmation.
- Treatment with neo-adjuvant systemic therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Dose Ablative Preoperative Radiation Treatment for Early-Stage Breast Cancer in Elderly Patients
The purpose of the study is to investigate the feasibility of a preoperative, single dose, ablative partial breast radiation treatment in patients with early-stage breast cancer.
Read the detailed description
A total of twenty-five patients will be treated with a single dose preoperative ablative radiation treatment. After a vigilant follow-up with MRI, breast conserving surgery will be performed 6 months after the ablative radiation treatment. The total follow-up time is 10 years.
This study aims to present an ablative radiotherapy treatment approach that could resolve to some extent the disadvantages of current breast conserving treatment in elderly low-risk breast cancer patients who are currently not treated according to guidelines due to co-morbidity.
- Conditions
- Breast Neoplasm
- Being tested
- Single dose ablative radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single dose ablative radiotherapyRadiation
A single dose ablative radiotherapy will be delivered prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| Single dose ablative radiotherapy | Experimental | Eligible patients for single dose ablative radiotherapy according to inclusion and exclusion criteria Receives: Radiation: Single dose ablative radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response
Measured: 6 months after radiotherapy
Secondary outcomes (11)
Radiological tumor response on MRI according to the RECIST criteria
Measured: Within 1 week and 2, 4 and 6 months after radiotherapy
Radiological tumor response on FDG-PET-CT according to the PERCIST criteria
Measured: At 6 months after radiotherapy
Quality of life according to EORTC QLQ-BR23 and EORTC QLQ-C30 questionnaires
Measured: Until 10 years after radiotherapy
Cosmetic results as assessed by patient questionnaire, radiation oncologist evaluation and BCCT.core software
Measured: Until 10 years after radiotherapy
Frailty assessment according to the Groningen Frailty Indicator
Measured: Until 10 years after radiotherapy
Functionality assessment using patient questionnaires on physical activity and the Hospital Anxiety and Depression Scale questionnaire.
Measured: Until 10 years after radiotherapy
Local relapse rates
Measured: Until 10 years after radiotherapy
Regional relapse rates
Measured: Until 10 years after radiotherapy
Distant relapse rates
Measured: Until 10 years after radiotherapy
Disease free survival
Measured: Until 10 years after radiotherapy
Overall survival
Measured: Until 10 years after radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study startOct 2014
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by UMC UtrechtThe 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, K.R. Charaghvandi, UMC Utrecht
- Investigators
- HJGD van den Bongard, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02316561
- Sponsor's protocol ID
- NL46017.041.13
- Acronym
- ABLATIVE
- Status last verified
- Jul 2018
- First submitted
- 10 Oct 2014
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Civil YA, Vasmel JE, Charaghvandi RK, Houweling AC, Vreuls CPH, van Diest PJ, Witkamp AJ, Doeksen A, van Dalen T, Felderhof J, van Dam I, Slotman BJ, Kirby AM, Verkooijen HM, van der Velde S, van der Leij F, van den Bongard HJGD. Preoperative Magnetic Resonance Guided Single-Dose Partial Breast Irradiation: 5-Year Results of the Prospective Single-Arm ABLATIVE Trial. Int J Radiat Oncol Biol Phys. 2025 Mar 1;121(3):613-622. doi: 10.1016/j.ijrobp.2024.07.2326. Epub 2024 Aug 2.
PubMed 39098432Groot Koerkamp ML, de Hond YJM, Maspero M, Kontaxis C, Mandija S, Vasmel JE, Charaghvandi RK, Philippens MEP, van Asselen B, van den Bongard HJGD, Hackett SS, Houweling AC. Synthetic CT for single-fraction neoadjuvant partial breast irradiation on an MRI-linac. Phys Med Biol. 2021 Apr 16;66(8). doi: 10.1088/1361-6560/abf1ba.
PubMed 33761491Charaghvandi RK, van Asselen B, Philippens ME, Verkooijen HM, van Gils CH, van Diest PJ, Pijnappel RM, Hobbelink MG, Witkamp AJ, van Dalen T, van der Wall E, van Heijst TC, Koelemij R, van Vulpen M, van den Bongard HJ. Redefining radiotherapy for early-stage breast cancer with single dose ablative treatment: a study protocol. BMC Cancer. 2017 Mar 9;17(1):181. doi: 10.1186/s12885-017-3144-5.
PubMed 28274211
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Dose Ablative Preoperative Radiation Treatment for Early-Stage Breast Cancer in Elderly Patients
- ClinicalTrials.gov ID
- NCT02316561
- Acronym / sponsor ID
- ABLATIVE / NL46017.041.13
- Conditions
- Breast Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 15 Dec 2014 (estimated)
- 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.
The purpose of the study is to investigate the feasibility of a preoperative, single dose, ablative partial breast radiation treatment in patients with early-stage breast cancer.
Detailed description
A total of twenty-five patients will be treated with a single dose preoperative ablative radiation treatment. After a vigilant follow-up with MRI, breast conserving surgery will be performed 6 months after the ablative radiation treatment. The total follow-up time is 10 years.
This study aims to present an ablative radiotherapy treatment approach that could resolve to some extent the disadvantages of current breast conserving treatment in elderly low-risk breast cancer patients who are currently not treated according to guidelines due to co-morbidity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single dose ablative radiotherapy | Experimental | Radiation: Single dose ablative radiotherapyEligible patients for single dose ablative radiotherapy according to inclusion and exclusion criteria |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- WHO performance scale ≤2.
- Females at least 50 years of age with unifocal cT1N0 breast cancer or females at least 70 years of age with an unifocal cT1-2(maximum 3 cm)N0 breast cancer:
- On tumor biopsy:
- Tumor negative sentinel node.
- Adequate communication and understanding skills of the Dutch language.
Key exclusion criteria (13 listed)
- Legal incapacity
- Indication for chemotherapy or immunotherapy (i.e. patients with an indication for endocrine therapy are eligible)
- BRCA gene mutation.
- Previous history of breast cancer
- Other type of malignancy within 5 years before breast cancer diagnosis. For adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin no specific time span from breast cancer diagnosis is required 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 radiotherapyA single dose ablative radiotherapy will be delivered prior to surgery | Radiation | Single dose ablative radiotherapy |
Primary outcome
Pathological complete response
Time frame: 6 months after radiotherapy
11 secondary outcomes
Radiological tumor response on MRI according to the RECIST criteria
Time frame: Within 1 week and 2, 4 and 6 months after radiotherapy
Radiological tumor response on FDG-PET-CT according to the PERCIST criteria
Time frame: At 6 months after radiotherapy
Quality of life according to EORTC QLQ-BR23 and EORTC QLQ-C30 questionnaires
Time frame: Until 10 years after radiotherapy
Cosmetic results as assessed by patient questionnaire, radiation oncologist evaluation and BCCT.core software
Time frame: Until 10 years after radiotherapy
Frailty assessment according to the Groningen Frailty Indicator
Time frame: Until 10 years after radiotherapy
Functionality assessment using patient questionnaires on physical activity and the Hospital Anxiety and Depression Scale questionnaire.
Time frame: Until 10 years after radiotherapy
Local relapse rates
Time frame: Until 10 years after radiotherapy
Regional relapse rates
Time frame: Until 10 years after radiotherapy
Distant relapse rates
Time frame: Until 10 years after radiotherapy
Disease free survival
Time frame: Until 10 years after radiotherapy
Overall survival
Time frame: Until 10 years after radiotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
- Derived from this study: PubMed 39098432Civil YA, Vasmel JE, Charaghvandi RK, Houweling AC, Vreuls CPH, van Diest PJ, Witkamp AJ, Doeksen A, van Dalen T, Felderhof J, van Dam I, Slotman BJ, Kirby AM, Verkooijen HM, van der Velde S, van der Leij F, van den Bongard HJGD. Preoperative Magnetic Resonance Guided Single-Dose Partial Breast Irradiation: 5-Year Results of the Prospective Single-Arm ABLATIVE Trial. Int J Radiat Oncol Biol Phys. 2025 Mar 1;121(3):613-622. doi: 10.1016/j.ijrobp.2024.07.2326. Epub 2024 Aug 2.
- Derived from this study: PubMed 33761491Groot Koerkamp ML, de Hond YJM, Maspero M, Kontaxis C, Mandija S, Vasmel JE, Charaghvandi RK, Philippens MEP, van Asselen B, van den Bongard HJGD, Hackett SS, Houweling AC. Synthetic CT for single-fraction neoadjuvant partial breast irradiation on an MRI-linac. Phys Med Biol. 2021 Apr 16;66(8). doi: 10.1088/1361-6560/abf1ba.
- Derived from this study: PubMed 28274211Charaghvandi RK, van Asselen B, Philippens ME, Verkooijen HM, van Gils CH, van Diest PJ, Pijnappel RM, Hobbelink MG, Witkamp AJ, van Dalen T, van der Wall E, van Heijst TC, Koelemij R, van Vulpen M, van den Bongard HJ. Redefining radiotherapy for early-stage breast cancer with single dose ablative treatment: a study protocol. BMC Cancer. 2017 Mar 9;17(1):181. doi: 10.1186/s12885-017-3144-5.
- 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. This study is not recruiting at the moment.
HJGD van den Bongard, MD, PhD principal investigator
UMC Utrecht
1 site in 1 country: 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 Neoplasm, run by UMC Utrecht 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 9 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: finished, as of the sponsor's last update on 20 Jul 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (time frame: 6 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 NCT02316561, which also lists 3 linked publications.
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 20 Jul 2018; AzTrials last refreshed its copy on 8 Nov 2026.