Breast CancerPAPBI-3NCT06362616
Preoperative Accelerated Partial Breast Irradiation in Patients With Locally Recurrent or Second Primary Breast Cancer
A study testing Preoperative accelerated partial breast irradiation, Breast conserving surgery and Sentinel node procedure in people with Breast Cancer, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
This study evaluates the acute toxicity and feasibility of repeat breast conserving therapy with preoperative accelerated partial breast re-irradiation (PAPBI) in female patients aged 51 years or older with ipsilateral recurrent or second primary low-risk breast cancer or DCIS. Read more about this study
- Who is it for?
- Ages 51 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Preoperative accelerated partial breast irradiation, Breast conserving surgery and Sentinel node procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Apr 2024to 11 Apr 2027
- 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 51 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients ≥ 51 years
- Ipsilateral breast cancer; recurrence or second primary
- Either histologically proven invasive adenocarcinoma (invasive adenocarcinoma with DCIS component is also accepted) or DCIS alone (calcification associated on imaging)
- Histologically proven estrogen receptor positive
- HER2neu negative
- In case of invasive adenocarcinoma: tumor size ≤ 3 cm. In case of DCIS alone: affected area ≤ 2.5 cm
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- Grade I or grade II (biopsy)
- cN0M0 (No evidence of nodal or distant metastases on axillary ultrasound and, if indicated, positron emission tomography-computed tomography (PET-CT) scan)
- Unifocal lesions on mammogram and MRI (small satellite lesions adjacent to the tumor are accepted as long as it is suitable for local excision)
- Interval since completion of local treatment of primary tumor > 12 months
- Previous radiotherapy (whole breast or partial) of the ipsilateral breast
- Repeat breast conserving surgery feasible
- World Health Organization (WHO) performance ≤ 2
- Written informed consent
- The patient is legally competent
Who cannot join
- ≥ grade 3 radiotherapy toxicity in the breast after treatment of the primary tumor
- Previous boost radiotherapy is not allowed, UNLESS the protocol tumor lies outside of the original boost area
- Distant metastases and/or synchronous contralateral invasive or in situ carcinoma
- Invasive lobular carcinoma (ILC) or pleiomorphic lobular carcinoma in situ (LCIS)
- ER negative subtype
- Lymphovascular invasion in biopsy
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- Neoadjuvant systemic treatment for the protocol tumor (except for pre-surgery hormonal therapy ≤ 2 months)
- (Planned) oncoplastic surgery with major tissue displacement
- Participation in another clinical trial that interferes with the locoregional treatment of this protocol.
- It is expected that dosimetric constraints cannot be met, such as lung/heart constraints.
- Patients with proven BRCA-mutations
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
The Netherlands Cancer Institute
Amsterdam, 1066CX
Astrid Scholten, MD PhD, +31205129111, a.scholten@nki.nl
About this study
This study evaluates the acute toxicity and feasibility of repeat breast conserving therapy with preoperative accelerated partial breast re-irradiation (PAPBI) in female patients aged 51 years or older with ipsilateral recurrent or second primary low-risk breast cancer or DCIS.
Read the detailed description
Standard treatment for an ipsilateral breast recurrence is a salvage mastectomy. However, repeat breast conserving therapy, involving breast conserving surgery (BCS) and postoperative re-irradiation, is a feasible alternative for a selected group of patients. In the primary setting, accelerated partial breast irradiation (APBI) is an international accepted treatment for a subset of breast cancer patients. Preoperative APBI (PAPBI) leads to low complication rates, limited fibrosis/induration in a small volume and good to excellent cosmetic results compared with results reported after postoperative APBI.
The aim of this study is to asses the acute toxicity and feasibility of repeat breast conserving therapy with PAPBI followed by BCS in patients aged 51 years or older with ipsilateral recurrent or second primary low-risk breast cancer or DCIS.
Patients undergo PAPBI 5 times (5 x 5.2 Gray). One-two weeks after completion of PAPBI, patients undergo BCS.
- Conditions
- Breast Cancer
- Being tested
- Preoperative accelerated partial breast irradiation, Breast conserving surgery, Sentinel node procedure, Biopsy track removal
- Keywords
- Recurrent breast cancer, Preoperative, 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.
Preoperative accelerated partial breast irradiationRadiation
Patients will be treated with 5 x 5.2 Gray (Gy) preoperative accelerated partial breast irradiation of the in situ tumor in the breast
Breast conserving surgeryProcedure or surgery
Patients will be treated with breast conserving surgery.
Sentinel node procedureProcedure or surgery
Patients will undergo a (repeat) sentinel node procedure.
Biopsy track removalProcedure or surgery
The biopsy track will be surgically removed.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative accelerated partial breast re-irradiation | Experimental | Patients receive preoperative accelerated partial breast irradiation of the in situ tumor in the breast followed by repeat breast conserving surgery Receives: Radiation: Preoperative accelerated partial breast irradiation; Procedure: Breast conserving surgery; Procedure: Sentinel node procedure; Procedure: Biopsy track removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute post-treatment toxicity
Acute post-treatment toxicity from start of local treatment up to 3 months after end of local treatment, assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Values range form 0 to 5, with 5 being the worst value. At least grade ≥ 2 toxicity is scored as an event.
Measured: 3,5 months
Secondary outcomes (5)
Fibrosis/induration
Assessment of fibrosis/induration grade at 3 months after end of local treatment, assessed the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Values range form 0 to 5, with 5 being the worst value.
Measured: 3 months
Patient-reported Outcome Measures (PROMS): EORTC Quality of Life Questionnaire (QLQ)-C30
PROMs will be assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire. All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scales represents a high/healthy level of functioning, whilst a high score for the symptom scales represents a high level of symptomatology or problems.
Measured: 3,5 months
Patient-reported Outcome Measures (PROMS): EORTC QLQ-BR23
PROMs will be assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-BR23 questionnaire. All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scales represents a high/healthy level of functioning, whilst a high score for the symptom scales represents a high level of symptomatology or problems.
Measured: 3,5 months
Patient-reported Outcome Measures (PROMS): Patient's Questionnaire Cosmesis
PROMs will be assessed using the Patient's Questionnaire Cosmesis, adapted from Sneeuw et al. (1992). Patients score their cosmetic outcome by the following outcomes: very satisfied, satisfied, neutral, unsatisfied and very unsatisfied.
Measured: 3,5 months
Cosmetic outcome according to the BCCT.core software program
Cosmetic outcome according to the Breast Cancer Conservative Treatment cosmetic results (BCCT.core) software program. The program returns an overall cosmetic outcome score (excellent, good, fair, or poor) based on the symmetry of the breasts, skin color, and scar visibility.
Measured: 3,5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start12 Apr 2024
- Primary completion11 Oct 2026 (estimated)
- Study completion11 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Center Haaglanden, Erasmus Medical Center, Albert Schweitzer Hospital
- Responsible party
- Sponsor
- Investigators
- Astrid Scholten, MD PhD, Principal investigator, The Netherlands Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362616
- Sponsor's protocol ID
- N23PBD
- Acronym
- PAPBI-3
- Status last verified
- Sep 2026
- First submitted
- 28 Mar 2024
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Accelerated Partial Breast Irradiation in Patients With Locally Recurrent or Second Primary Breast Cancer
- ClinicalTrials.gov ID
- NCT06362616
- Acronym / sponsor ID
- PAPBI-3 / N23PBD
- Conditions
- Breast Cancer
- Keywords
- Recurrent breast cancer, Preoperative, Partial breast irradiation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Collaborators
- Medical Center Haaglanden, Erasmus Medical Center, Albert Schweitzer Hospital
- Study start
- 12 Apr 2024 (actual)
- Primary completion
- 11 Oct 2026 (estimated)
- Study completion
- 11 Apr 2027 (estimated)
- First posted
- 12 Apr 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.
This study evaluates the acute toxicity and feasibility of repeat breast conserving therapy with preoperative accelerated partial breast re-irradiation (PAPBI) in female patients aged 51 years or older with ipsilateral recurrent or second primary low-risk breast cancer or DCIS.
Detailed description
Standard treatment for an ipsilateral breast recurrence is a salvage mastectomy. However, repeat breast conserving therapy, involving breast conserving surgery (BCS) and postoperative re-irradiation, is a feasible alternative for a selected group of patients. In the primary setting, accelerated partial breast irradiation (APBI) is an international accepted treatment for a subset of breast cancer patients. Preoperative APBI (PAPBI) leads to low complication rates, limited fibrosis/induration in a small volume and good to excellent cosmetic results compared with results reported after postoperative APBI.
The aim of this study is to asses the acute toxicity and feasibility of repeat breast conserving therapy with PAPBI followed by BCS in patients aged 51 years or older with ipsilateral recurrent or second primary low-risk breast cancer or DCIS.
Patients undergo PAPBI 5 times (5 x 5.2 Gray). One-two weeks after completion of PAPBI, patients undergo BCS.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preoperative accelerated partial breast re-irradiation | Experimental | Radiation: Preoperative accelerated partial breast irradiation, Procedure: Breast conserving surgery, Procedure: Sentinel node procedure, Procedure: Biopsy track removalPatients receive preoperative accelerated partial breast irradiation of the in situ tumor in the breast followed by repeat breast conserving surgery |
Who may qualify
- Ages
- 51 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Female patients ≥ 51 years
- Ipsilateral breast cancer; recurrence or second primary
- Either histologically proven invasive adenocarcinoma (invasive adenocarcinoma with DCIS component is also accepted) or DCIS alone (calcification associated on imaging)
- Histologically proven estrogen receptor positive
- HER2neu negative
Key exclusion criteria (11 listed)
- ≥ grade 3 radiotherapy toxicity in the breast after treatment of the primary tumor
- Previous boost radiotherapy is not allowed, UNLESS the protocol tumor lies outside of the original boost area
- Distant metastases and/or synchronous contralateral invasive or in situ carcinoma
- Invasive lobular carcinoma (ILC) or pleiomorphic lobular carcinoma in situ (LCIS)
- ER negative subtype
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 |
|---|---|---|
| Preoperative accelerated partial breast irradiationPatients will be treated with 5 x 5.2 Gray (Gy) preoperative accelerated partial breast irradiation of the in situ tumor in the breast | Radiation | Preoperative accelerated partial breast re-irradiation |
| Breast conserving surgeryPatients will be treated with breast conserving surgery. | Procedure or surgery | Preoperative accelerated partial breast re-irradiation |
| Sentinel node procedurePatients will undergo a (repeat) sentinel node procedure. | Procedure or surgery | Preoperative accelerated partial breast re-irradiation |
| Biopsy track removalThe biopsy track will be surgically removed. | Procedure or surgery | Preoperative accelerated partial breast re-irradiation |
Primary outcome
Acute post-treatment toxicity
Time frame: 3,5 months
Acute post-treatment toxicity from start of local treatment up to 3 months after end of local treatment, assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Values range form 0 to 5, with 5 being the worst value. At least grade ≥ 2 toxicity is scored as an event.
5 secondary outcomes
Fibrosis/induration
Time frame: 3 months
Patient-reported Outcome Measures (PROMS): EORTC Quality of Life Questionnaire (QLQ)-C30
Time frame: 3,5 months
Patient-reported Outcome Measures (PROMS): EORTC QLQ-BR23
Time frame: 3,5 months
Patient-reported Outcome Measures (PROMS): Patient's Questionnaire Cosmesis
Time frame: 3,5 months
Cosmetic outcome according to the BCCT.core software program
Time frame: 3,5 months
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 17 Sep 2026.
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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.
Astrid Scholten, MD PhD principal investigator
The Netherlands Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative accelerated partial breast irradiation, Breast conserving surgery and Sentinel node procedure 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 15 inclusion and 11 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 17 Sep 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.
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 Tess Snellen, MD (0205129111 ext. 3448, t.snellen@nki.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute post-treatment toxicity (time frame: 3,5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2026.