Recurrent Breast CarcinomaPhase 2REPEATNCT06640881
Preoperative Partial Breast Reirradiation and Repeat Breast-conserving Surgery in Patients With Recurrent Breast Cancer: the REPEAT Trial
A Phase 2 study testing ablative single-dose PBI in people with Recurrent Breast Carcinoma and Ipsilateral Recurrence, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
Over the past decades, interest in second breast-conserving therapy (BCT) has increased due to, among others, advancements in radiotherapy techniques. Preoperative partial breast irradiation (PBI) is an experimental treatment for patients with low-risk primary breast cancer. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Recurrent Breast Carcinoma, Ipsilateral Recurrence
- What is being tested?
- ablative single-dose PBI
- 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
- 1 Jan 2025to Dec 2026
- Phase
- Phase 2
- 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 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 an ipsilateral invasive breast cancer event or DCIS (i.e. recurrence, second primary) after previous breast conserving surgery and radiotherapy (for invasive breast cancer/carcinoma in situ)
- Tumor characteristics: - - Tumor size ≤ 2 cm, unifocal on MRI
- On tumor biopsy:
- Bloom-Richardson grade 1 or 2,
- non-lobular invasive histological type carcinoma,
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- accompanying (non-extensive) DCIS is accepted within the tumor size of 2 cm on mammography and/or tumor biopsy, including no non-mass enhancement on MRI,
- ER-positive and HER2-negative tumor,
- No lymphovascular invasion.
- Clinical node negative on PET-CT, ultrasound and MRI
- No distant metastases
- Repeat breast-conserving surgery is feasible, if no or mild late toxicity (no grade 2 or higher) from previous breast-conserving therapy
- Adequate communication and understanding skills of the Dutch language
- Written informed consent
Who cannot join
- Ipsilateral invasive breast cancer recurrence less than 2 years after first breast conserving therapy for breast cancer or ductal carcinoma in situ
- Legal incapacity
- Known breast cancer mutation gene carrier
- Previous ipsilateral mastectomy
- Collagen synthesis disease (e.g. Osteogeneis imperfecta, Ehlers-Danlos syndrome, systemic lupus erythematosus)
- Invasive lobular carcinoma
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- MRI absolute contraindications as defined by the Department of Radiology
- Indication for treatment with neoadjuvant chemotherapy
- Non-feasible dosimetric RT plan
- Breast implants
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
Amsterdam UMC / VU Medical Centre
Amsterdam
Lisca Wurfbain, MD, +31 625414750, l.f.wurfbain@amsterdamumc.nl
Desiree HJGD Dr. van den Bongard, Dr.
About this study
Official title: Preoperative Partial Breast Reirradiation and Repeat Breast-conserving Surgery in Patients With Recurrent Breast Cancer: the REPEAT Trial - a Study Protocol
Over the past decades, interest in second breast-conserving therapy (BCT) has increased due to, among others, advancements in radiotherapy techniques. Preoperative partial breast irradiation (PBI) is an experimental treatment for patients with low-risk primary breast cancer. This approach can downstage the tumor, and may possibly reduce toxicity and improve cosmetic outcomes compared to postoperative radiotherapy. This study aims to evaluate the feasibility of single-dose preoperative PBI and second breast-conserving surgery (BCS) for patients with an ipsilateral recurrent breast event (IRBE) after previous BCT.
The REPEAT trial is a multicenter, prospective, single-arm trial investigating ablative single-dose preoperative PBI in patients with an IRBE. Eligible patients are ≥ 50 years, have a unifocal non-lobular invasive breast cancer ≤ 2 cm, Bloom-Richardson grade 1 or 2, estrogen receptor-positive, HER2-negative and clinically negative axillary lymph nodes. The study plans to enroll 25 patients. Radiotherapy planning will involve the use of CT and MRI in the treatment position. Single-dose PBI of 20 Gy to the tumor and 15 Gy to the surrounding 2 cm of breast tissue will be delivered using a conventional or MR-guided linear accelerator. Tumor response will be monitored preoperatively using MRI and liquid biopsies to identify biomarkers for evaluating radiosensitivity. BCS will be performed 3 weeks post-PBI. The primary endpoint is the incidence of grade 2 or higher treatment-associated acute toxicity within 90 days. Secondary endpoints include the evaluation of acute (grade 1) and late toxicity, radiologic and pathologic response, mastectomy rate, patient-reported outcomes, cosmetic outcome, local, regional and distant recurrence rates, survival outcome, and biomarkers in liquid biopsies and tumor tissue. Patients will be followed up to 5 years after PBI.
This trial will evaluate the feasibility of single-dose preoperative PBI and BCS for patients with IRBE. This treatment approach is expected to minimize the irradiated volume, reduce toxicity, and improve cosmetic outcomes compared to postoperative PBI after second BCS. Identifying biomarkers for radiosensitivity will help in selection patients and tailoring treatment.
- Conditions
- Recurrent Breast Carcinoma, Ipsilateral Recurrence
- Being tested
- ablative single-dose PBI
- Keywords
- single-dose preoperative radiotherapy, pathologic response, radiologic response, cosmetic outcome, partial breast irradiation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ablative single-dose PBIRadiation
Also called baseline (prior to RT) and prior to BCS, toxicity, PROMS and cosmetic outcome will be assessed., a preoperative MRI will be performed three weeks following RT to evaluate the acute tumor response
ablative single-dose PBI followed by BCS after three weeks At baseline (prior to RT) and prior to BCS, toxicity, PROMS and cosmetic outcome will be assessed. Additionally, a preoperative MRI will be performed three weeks following RT to evaluate the acute tumor response.
| Study group | Role | What they receive |
|---|---|---|
| ablative single-dose PBI followed by BCS after three weeks | Experimental | Eligible patients with a low-risk ipsilateral recurrent breast cancer previously treated with breast-conserving surgery and postoperative radiotherapy, will be treated with re-irradiation (i.e. ablative single-dose PBI) followed by second BCS after three weeks. Receives: Radiation: ablative single-dose PBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute toxicity
The incidence of grade 2 or higher treatment-associated acute toxicity within 90 days
Measured: 90 days
Secondary outcomes (7)
Toxicity
Assessment of treatment-induced toxicity
Measured: 3,6,12 weeks and 1,2,3,4,5 years
response
Assessment of radiologic and pathologic response, mastectomy rate
Measured: 3,6,12 weeks and 1,2,3,4,5 years
PROMS
Assessment of PROMs
Measured: 3,6,12 weeks and 1,2,3,4,5 years
cosmetic results
Assessment of cosmetic results
Measured: 3,6,12 weeks and 1,2,3,4,5 years
oncological outcomes
Assessment of oncological outcomes
Measured: 1,2,3,4,5 years
immune response
Assessment of RT-associated immune response and biomarkers in blood and tumor tissue
Measured: 3,6,12 weeks and 1,2,3,4,5 years
patient comfort during RT treatment delivery
Assessment of patient comfort during RT treatment delivery
Measured: during RT treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Jan 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (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 Recurrent Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Amsterdam UMC, location VUmcThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Desiree H.J.G.D. van den Bongard, MD Ph, VU University of Amsterdam
- Investigators
- Desiree HJG van den Bongard, MD PhD, Principal investigator, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640881
- Sponsor's protocol ID
- NL85983.018.24
- Acronym
- REPEAT
- Status last verified
- Jul 2026
- First submitted
- 8 Oct 2024
- 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 Y, Wurfbain L, Jonker L, van der Sangen M, Oei A, Duvivier K, Bijker N, Meijnen P, van Kesteren Z, Palacios M, Barbe E, Menke-van der Houven van Oordt W, Diepenhorst G, Thijssen V, Slotman B, Verhoeff J, Schipper RJ, van den Bongard D. Preoperative partial breast reirradiation and repeat breast-conserving surgery in patients with recurrent breast cancer: the prospective single-arm REPEAT trial - a study protocol. BMJ Open. 2025 Jul 18;15(7):e096510. doi: 10.1136/bmjopen-2024-096510.
PubMed 40681188
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
- Preoperative Partial Breast Reirradiation and Repeat Breast-conserving Surgery in Patients With Recurrent Breast Cancer: the REPEAT Trial - a Study Protocol
- ClinicalTrials.gov ID
- NCT06640881
- Acronym / sponsor ID
- REPEAT / NL85983.018.24
- Conditions
- Recurrent Breast Carcinoma, Ipsilateral Recurrence
- Keywords
- single-dose preoperative radiotherapy, pathologic response, radiologic response, cosmetic outcome, partial breast irradiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 15 Oct 2024 (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.
Over the past decades, interest in second breast-conserving therapy (BCT) has increased due to, among others, advancements in radiotherapy techniques. Preoperative partial breast irradiation (PBI) is an experimental treatment for patients with low-risk primary breast cancer. This approach can downstage the tumor, and may possibly reduce toxicity and improve cosmetic outcomes compared to postoperative radiotherapy. This study aims to evaluate the feasibility of single-dose preoperative PBI and second breast-conserving surgery (BCS) for patients with an ipsilateral recurrent breast event (IRBE) after previous BCT.
The REPEAT trial is a multicenter, prospective, single-arm trial investigating ablative single-dose preoperative PBI in patients with an IRBE. Eligible patients are ≥ 50 years, have a unifocal non-lobular invasive breast cancer ≤ 2 cm, Bloom-Richardson grade 1 or 2, estrogen receptor-positive, HER2-negative and clinically negative axillary lymph nodes. The study plans to enroll 25 patients. Radiotherapy planning will involve the use of CT and MRI in the treatment position. Single-dose PBI of 20 Gy to the tumor and 15 Gy to the surrounding 2 cm of breast tissue will be delivered using a conventional or MR-guided linear accelerator. Tumor response will be monitored preoperatively using MRI and liquid biopsies to identify biomarkers for evaluating radiosensitivity. BCS will be performed 3 weeks post-PBI. The primary endpoint is the incidence of grade 2 or higher treatment-associated acute toxicity within 90 days. Secondary endpoints include the evaluation of acute (grade 1) and late toxicity, radiologic and pathologic response, mastectomy rate, patient-reported outcomes, cosmetic outcome, local, regional and distant recurrence rates, survival outcome, and biomarkers in liquid biopsies and tumor tissue. Patients will be followed up to 5 years after PBI.
This trial will evaluate the feasibility of single-dose preoperative PBI and BCS for patients with IRBE. This treatment approach is expected to minimize the irradiated volume, reduce toxicity, and improve cosmetic outcomes compared to postoperative PBI after second BCS. Identifying biomarkers for radiosensitivity will help in selection patients and tailoring treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ablative single-dose PBI followed by BCS after three weeks | Experimental | Radiation: ablative single-dose PBIEligible patients with a low-risk ipsilateral recurrent breast cancer previously treated with breast-conserving surgery and postoperative radiotherapy, will be treated with re-irradiation (i.e. ablative single-dose PBI) followed by second BCS after three weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- WHO performance scale ≤ 2
- Females at least 50 years of age with an ipsilateral invasive breast cancer event or DCIS (i.e. recurrence, second primary) after previous breast conserving surgery and radiotherapy (for invasive breast cancer/carcinoma in situ)
- Tumor characteristics: - - Tumor size ≤ 2 cm, unifocal on MRI
- Bloom-Richardson grade 1 or 2,
- non-lobular invasive histological type carcinoma,
Key exclusion criteria (10 listed)
- Ipsilateral invasive breast cancer recurrence less than 2 years after first breast conserving therapy for breast cancer or ductal carcinoma in situ
- Legal incapacity
- Known breast cancer mutation gene carrier
- Previous ipsilateral mastectomy
- Collagen synthesis disease (e.g. Osteogeneis imperfecta, Ehlers-Danlos syndrome, systemic lupus erythematosus)
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 |
|---|---|---|
| ablative single-dose PBIAlso: baseline (prior to RT) and prior to BCS, toxicity, PROMS and cosmetic outcome will be assessed., a preoperative MRI will be performed three weeks following RT to evaluate the acute tumor responseablative single-dose PBI followed by BCS after three weeks At baseline (prior to RT) and prior to BCS, toxicity, PROMS and cosmetic outcome will be assessed. Additionally, a preoperative MRI will be performed three weeks following RT to evaluate the acute tumor response. | Radiation | ablative single-dose PBI followed by BCS after three weeks |
Primary outcome
Acute toxicity
Time frame: 90 days
The incidence of grade 2 or higher treatment-associated acute toxicity within 90 days
7 secondary outcomes
Toxicity
Time frame: 3,6,12 weeks and 1,2,3,4,5 years
response
Time frame: 3,6,12 weeks and 1,2,3,4,5 years
PROMS
Time frame: 3,6,12 weeks and 1,2,3,4,5 years
cosmetic results
Time frame: 3,6,12 weeks and 1,2,3,4,5 years
oncological outcomes
Time frame: 1,2,3,4,5 years
immune response
Time frame: 3,6,12 weeks and 1,2,3,4,5 years
patient comfort during RT treatment delivery
Time frame: during RT treatment
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 40681188Civil Y, Wurfbain L, Jonker L, van der Sangen M, Oei A, Duvivier K, Bijker N, Meijnen P, van Kesteren Z, Palacios M, Barbe E, Menke-van der Houven van Oordt W, Diepenhorst G, Thijssen V, Slotman B, Verhoeff J, Schipper RJ, van den Bongard D. Preoperative partial breast reirradiation and repeat breast-conserving surgery in patients with recurrent breast cancer: the prospective single-arm REPEAT trial - a study protocol. BMJ Open. 2025 Jul 18;15(7):e096510. doi: 10.1136/bmjopen-2024-096510.
- 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.
Desiree HJG van den Bongard, MD PhD principal investigator
Amsterdam UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ablative single-dose PBI in people with Recurrent Breast Carcinoma and Ipsilateral Recurrence, run by Amsterdam UMC, location VUmc 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 14 inclusion and 10 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 F van Roij, MD (+31 611094077, 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?
Acute toxicity (time frame: 90 days). 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 NCT06640881, 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.