Breast NeoplasmsPRADAIIBENCT06739655
Preoperative Radiation Therapy and Immediate Breast Reconstruction
A study testing Preoperative radiotherapy, Postoperative radiotherapy and Immediate breast reconstruction in people with Breast Neoplasms and Breast Carcinoma, run by Cancer Research Antwerp at 6 sites in Belgium.
Trial summary
The goal of this phase III randomized controlled trial (PRADAIIBE) is to assess if preoperative radiation therapy (Preop-RT) combined with immediate breast reconstruction (IBR) can safely improve both aesthetic and quality of life outcomes in breast cancer patients, compared to the standard of care (SoC) therapy… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Breast Carcinoma, Breast Adenocarcinoma
- What is being tested?
- Preoperative radiotherapy, Postoperative radiotherapy and Immediate breast reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 6 sitesBelgium
- Study dates
- 20 Feb 2025to 20 Feb 2038
- 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
- In order to be eligible to participate in this study, a participant must meet all of the following criteria:
- 1. Women ≥18 years with histopathologically confirmed breast cancer who:
- 1.a. require SSM/NSM for any reason (e.g. extensive disease)
- 1.b. require postoperative radiation therapy of at least the chest wall
- c. have a wish for a breast reconstruction
- An Eastern Cooperative Oncology Group (ECOG) performance status grade ≤ 2
- Participant is able and willing to provide written informed consent, which includes compliance with and ability to undergo all study procedures, and attend the scheduled follow-up visit(s) per protocol.
Who cannot join
- A potential participant who meets any of the following criteria will be excluded from participation in this study:
- A previous history of breast cancer or irradiation of the chest wall for any other indication, on the other side (ipsilateral). A bilateral SSM/NSM + reconstruction (e.g. in case of a contralateral prophylactic SSM/NSM), or previous contralateral breast cancer disease/treatment, do not fall under this criterium and are thus allowed.
- Collagen synthesis disease
- Ongoing pregnancy
- Actively breastfeeding
- Smoking at time of inclusion (a history of smoking is allowed but needs to be registered in the eCRF). No interval between smoking cessation and study inclusion is defined, but the reconstructive surgeon needs to be willing to operate the patient using autologous tissue transfer. This generally translates to a smoking cessation of >3months preoperatively.
- BMI > 35 kg/m2
- cT4d tumour, metastatic disease or any reason making SSM/NSM not indicated
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Belgium6 sites, 6 recruiting
- Not yet recruiting
AZ Klina
Brasschaat, Antwerp, 2930
Research AZ Klina, datanurse.onco@klina.be
- Recruiting
Universitair Ziekenhuis Antwerpen (UZA)
Edegem, Antwerpen, 2650
Isabelle Nietvelt, +32 3 821 30 00 ext. +32, isabelle.nietvelt@uza.be
Christophe Van Berckelaer, MD
- Not yet recruiting
Universitair Ziekenhuis Gent (UZGent)
Ghent, Oost Vlaanderen, 9000
Jessie De Kinder, +329 332 32 78 ext. +32, jessie.dekinder@uzgent.be
Bernard Depypere, MD, PhD
- Recruiting
AZ Groeninge
Kortrijk, West Vlaanderen, 8500
Inge Meyer, +3256 63 39 03 ext. +32, inge.meyer@azgroeninge.be
Isabelle Kindts, MD, PhD
- Recruiting
CHU Namur
Namur, Namur, 5000
Caroline Yague Sanz, +32 81 72 04 11 ext. +32, caroline.yaguesanz@chuuclnamur.uclouvain.be
Vincent Remouchamps, MD, PhD
- Recruiting
Ziekenhuis aan de stroom
Wilrijk, Antwerpen, 2610
Tom Quisenaerts, MD, +3234433759 ext. +32, Tom.quisenaerts@zas.be
Melanie Machiels, MD, PhD
About this study
Official title: Preoperative Radiation Therapy and Immediate Breast Reconstruction, a Phase 3 Randomized Controlled Trial in the Belgian Population
The goal of this phase III randomized controlled trial (PRADAIIBE) is to assess if preoperative radiation therapy (Preop-RT) combined with immediate breast reconstruction (IBR) can safely improve both aesthetic and quality of life outcomes in breast cancer patients, compared to the standard of care (SoC) therapy consisting of post-mastectomy radiation therapy (PMRT) and delayed/immediate breast reconstruction, in a population of breast cancer patients with an indication of mastectomy and PMRT.
The following hypotheses and outcomes will be assessed at the primary endpoint of 1 year of follow-up:
Read more
- Efficacy: Does Preop-RT+IBR lead to a higher BREAST-Q satisfaction with breasts score (primary endpoint), EQ-5D-5L VAS score , EQ-5D-5L Index score, AIS-Total Aesthetic Score, or a shorter treatment duration compared to SoC?
- Safety: Does Preop-RT+IBR lead to an increase in adverse events (general or surgical), a lower rate of pathologic Complete Response (pCR), or worse survival outcomes compared to SoC? [Note: this study was not powered as a non-inferiority trial, all outcomes will be pooled internationally with parallel studies]
Eligible and consenting participants will undergo screening and baseline assessments. They will then be randomised between experimental (Preop-RT+IBR) and control (SoC) groups, in a 1:1 stratified variable block size design. Follow-up will take place at 3 months, 1, 2, 5, and 10 years after the last study treatment. At baseline and during each follow-up visit each participant will complete the Breast Q 'satisfaction with breasts' and EQ-5D-5L scales, photographs will be taken. During follow-up pCR will be assessed if applicable, adverse events will be registered, and oncological follow-up will be recorded.
Read the detailed description
The PRADAIIBE study is a multicentric phase III randomized controlled trial, investigating the effects of radiation therapy timing on breast reconstruction results in breast cancer patients.
This study will recruit adult female breast cancer patients from the Belgian population, who have an indication for mastectomy, Post-Mastectomy Radiation Therapy (PMRT), and also have a wish for breast reconstruction.
After informed consent is signed, patients will be screened, and included in the study if all eligibility criteria are met. If they are not eligible for participation or choose to withdraw after the ICF was signed, they will be registered as a 'screen failure'.
After study inclusion, baseline assessments take place, this includes two questionnaires, one focussed on patient's satisfaction with their own breasts (BREAST-Q v2, BQ-score), the other one focussed on their quality of life perception (EQ-5D-5L VAS-score and Index-score). Next, four photographs of the exposed breast area will be taken. These photographs will later be assessed by an expert panel (AIS-TAS).
Eligible participants are randomized using the central eCRF randomization tool (Castor EDC). Randomisation is stratified on study site and a variable block size will be used. Resulting in random assignment to one of the following treatment arms:
- Control (SoC) treatment arm: Mastectomy followed by PMRT and delayed (or immediate) breast reconstruction.
- Experimental treatment arm: preoperative radiation therapy (preop-RT) followed by mastectomy and immediate breast reconstruction.
Those assigned to the control group will follow the standard of care (SoC) treatment consisting of oncological surgery (within 6 weeks of randomisation or end of preop chemotherapy) followed by radiation therapy (PMRT) within 6-12 weeks. The breast reconstruction surgery will take place either at the same time (e.g. tissue expander implantation) as the oncological surgery, or at a delayed moment (usually a 6-12 months delay).
Patients assigned to the intervention group will receive preop-RT (within 6 weeks of randomisation or end of preop chemotherapy), and after an interval of 2-6 weeks mastectomy combined with immediate breast reconstruction will be performed. The radiation therapy will be administered according to the same principles as PMRT/Whole Breast Radiation Therapy (WBRT). This change to preoperative timing of the radiation therapy allows for immediate breast reconstruction without irradiation of the reconstructed breast.
In the unexpected event of tumour downstaging due to preoperative treatment, changing the indication from mastectomy to breast conserving surgery (BCS), while the patient has already been included, it is allowed within the study protocol to perform BCS. In this case the patient should receive the treatment and surgery which is in their best interest. The same follow-up will be provided. In statistical analysis results from such patients will be handled according to the inter-current events (ICE) strategies defined in the SAP. However, such downstaging is not expected from preop-RT at such a short treatment interval of 2-6 weeks.
Systemic therapy will be administered per standard of care, according to the discretion of the treating medical oncologist. Systemic therapy details will be registered in the eCRF, but it is not considered as part of the study treatments, and will not be manipulated within this trial.
After the treatment period is finished (last study treatment) follow-up will take place at 3 months, 1 year, 2 years, 5 years and 10 years. In the control group, patients undergoing delayed breast reconstruction will be invited to an intermediate follow up visit (IMFU) visit at 3 months after conclusion of radiation therapy. The reason for this IMFU visit is to capture the outcomes of interest in the interval between mastectomy and breast reconstruction, as well as provide continued study follow-up during this long treatment interval of +/- 6-12 months.
During each follow-up visit the BREAST-Q and EQ-5D-5L questionnaires will be assessed, photographs will be taken and evaluated at a later (expert panel using the AIS-tool), adverse events will be elicited, pathologic response assessed, treatment milestones are recorded (treatment duration) and oncological recurrence is assessed from the +1 year visit onwards according to the events and outcomes described in the DATECAN 2015 initiative.
- Conditions
- Breast Neoplasms, Breast Carcinoma, Breast Adenocarcinoma, Cancer, Neoplasm
- Being tested
- Preoperative radiotherapy, Postoperative radiotherapy, Immediate breast reconstruction, Immediate or delayed breast reconstruction
- Keywords
- Breast cancer, Radiotherapy, PRADA, Breast reconstruction, BreastQ, QoL, Skin Sparing Mastectomy, Mastectomy, Breast surgery, radiation therapy, Preoperative radiation therapy, Preoperative RT, Cosmesis, Breast satisfaction, Immediate Breast Reconstruction
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative radiotherapyRadiation
Also called Preop-RT, Neoadjuvant radiation therapy, NART
In this study patients assigned to the experimental treatment arm will receive preoperative radiation therapy instead of postoperative radiation therapy (PMRT).
This preoperative radiation therapy will be administered according to the standard of care (SoC) principles for PMRT and Whole Breast Radiation Therapy (WBRT) as defined by international guidelines.
Postoperative radiotherapyRadiation
Also called Postop-RT, Postmastectomy Radiation Therapy, PMRT, Adjuvant Radiation Therapy
Standard of care (SoC) postoperative radiotherapy, as defined by international guidelines.
Immediate breast reconstructionProcedure or surgery
Also called IBR
In the experimental arm of the PRADAIIBE, the participants will undergo immediate breast reconstruction surgery. This is defined as breast reconstruction taking place at the same time as oncological surgery. Using one of the following primary techniques: 1) Autologous tissue reconstruction ; 2) Breast implant based reconstruction; 3) Combined autologous tissue and breast implant reconstruction. These techniques can take place in a single phase, or in a two-phased (tissue expander) approach.
Adjuvant techniques (e.g.: lipofilling, mesh, ADM etc.) could be added.
Immediate or delayed breast reconstructionProcedure or surgery
In the standard arm of the PRADAIIBE, the participants will undergo immediate or delayed breast reconstruction surgery. This is defined as breast reconstruction taking place at the same time as oncological surgery (immediate), or at a later time (delayed). Using one of the following primary techniques: 1) Autologous tissue reconstruction ; 2) Breast implant based reconstruction; 3) Combined autologous tissue and breast implant reconstruction. These techniques can take place in a single phase, or in a two-phased (tissue expander) approach. Adjuvant techniques (e.g.: lipofilling, mesh, ADM etc.) could be added.
| Study group | Role | What they receive |
|---|---|---|
| Standard treatment arm (SoC; PostOperative RT) | Active comparator | Treatment in this arm consists of:
1. Mastectomy
2. Immediate or delayed breast reconstruction.
3. Postoperative radiation therapy, according to the SoC as indicated by international guidelines.
[Systemic treatments are not considered as study treatments and will be implemented at the discretion of the treating physician.] Receives: Radiation: Postoperative radiotherapy; Procedure: Immediate or delayed breast reconstruction |
| Experimental treatment arm (PreOperative RT) | Experimental | Treatment in this arm consists of:
1. Preoperative radiation therapy (Preop-RT). Preop-RT will be administered according to the same parameters and quality standards as PMRT/WBRT, as indicated by international guidelines.
2. Mastectomy combined with immediate breast reconstruction, after a 2-6 weeks interval.
[Systemic treatments are not considered as study treatments and will be implemented at the discretion of the treating physician.] Receives: Radiation: Preoperative radiotherapy; Procedure: Immediate breast reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient's satisfaction with breasts.
Operationalisation (measurement variable):
The satisfaction with breasts outcome variable is operationalised through the "satisfaction with breasts" scale from the BREAST-Q (v2) 'Reconstruction', 'Breast Conserving Treatment', or 'Mastectomy' modules (as applicable). The answers from the questionnaire are then transformed into a 'BREAST-Q Score', using the provided conversion scales.(3) The BREAST-Q score can range from 0 to100.
Analysis metric:
The transformed value of the BREAST-Q score will be used for analysis.
Method of aggregation:
Mean, SD, median, IQR, and range will be reported. For comparisons and estimands, please refer to the SAP.
Measured: Measured at 3 months, 1year, 2 years, 5 years and 10 years after last locoregional treatment. Primary endpoint: 1 year after LST.
Secondary outcomes (7)
Quality of Life (EQ-5D-5L VAS score)
Operationalisation (measurement variable):
'Quality of Life' will be assessed using the EQ-5D-5L questionnaire. Deriving the VAS-score from the VAS-scale Range EQ-5D-5L VAS-score: 0-100
Analysis metric:
The VAS-score will be used as recorded.
Method of aggregation:
Mean, SD, median, IQR, and range will be reported. For comparisons and estimands, please refer
Measured: A baseline assessment is performed during the screening visit, followed by repeated measurements during the IMFU (if applicable), 3M, 1Y, 2Y, 5Y, and 10Y follow-up visits.
Quality of Life (Index score)
Operationalisation (measurement variable):
'Quality of Life' will be assessed using the EQ-5D-5L questionnaire. The index score is calculated from the Likert-scale answers, using a formula validated in the Belgian population.
Range EQ-5D-5L Index-score: -0.533-0.962.
Analysis metric:
The Index-score will be transformed to a scale between 0 and 1, proportional to its original distribution using the following formula:
F(IS) = (IS+0.533)/1.495 The rationale for this transformation, is to adhere to the scale proposed by the EQ-5D-5L documentation, and improve interpretability.
Method of aggregation:
Mean, SD, median, IQR, and range will be reported. For comparisons and estimands, please refer
Measured: A baseline assessment is performed during the screening visit, followed by repeated measurements during the IMFU (if applicable), 3M, 1Y, 2Y, 5Y, and 10Y follow-up visits.
Breast cosmesis, objective assessment (AIS - TAS)
Operationalisation (measurement variable):
Breast cosmesis will be assessed through a blinded panel of experts, using the 'Aesthetic Items Scale' to score a set of photographs taken during study visits. This set will consist of 4 2D digital photographs. The AIS has 5 items, each are scored from 1 to 5. These items are then summed to derive the 'Total Aesthetic Score' (TAS). The TAS can range from 5 to 25.
Analysis metric:
The derived value of the Total Aesthetic Score (TAS) from each assessor will be averaged to derive the TAS of each set of photos.
Method of aggregation:
Mean, SD, median, IQR, and range will be reported. For comparisons and estimands, please refer to the SAP.
Measured: Photographs are taken during the screening visit, followed by repeated photographs during the IMFU (if applicable), 3M, 1Y, 2Y, 5Y, and 10Y follow-up visits. Expert panel assessment will take place at a later moment.
Frequency and severity of adverse events (General AEs)
During the study all adverse events (AEs) codes and grades will be recorded in the eCRF, based on the 'National Cancer Institute Common Terminology Criteria for Adverse Events' (NCI-CTCAE) v5.0 reporting system.
Analysis metric:
Tabulation of AE frequency, type and severity. As well as the highest grade AE for each participant.
Method of aggregation:
AEs will be aggregated based on their grades. Two composite measures will be reported, consisting of 1) any AE vs. no AE, and 2) grade > 3 AEs vs. no or grade <3 AEs. Tables presenting both frequency and proportions of each grade and the composite measures will be presented. Proportions will be reported as AEs compared to 'highest grade per patient', and to 'total set of AEs'. For comparisons and estimands, please refer to the SAP.
Measured: AEs will be assessed and recorded continuously, with explicit querying during all follow-up visits.
Frequency and severity of adverse events (Surgical AEs)
During the study all adverse events (AEs) codes and grades will be recorded in the eCRF, based on the 'National Cancer Institute Common Terminology Criteria for Adverse Events' (NCI-CTCAE) v5.0 reporting system. ). The relationship to surgical study interventions will be registered in the eCRF.
Analysis metric:
Tabulation of surgical AE frequency, type and severity. As well as the highest grade surgical AE for each participant.
Method of aggregation:
Surgical AEs will be aggregated based on their grades. Two composite measures will be reported, consisting of 1) any AE vs. no AE, and 2) grade > 3 AEs vs. no or grade <3 AEs, relating to surgical AEs. Tables presenting both frequency and proportions of each grade and composite measures will be presented. Proportions will be reported as surgical AEs compared to 'highest grade per patient', and to 'total set of surgical AEs'. For comparisons and estimands, please refer to the SAP.
Measured: AEs will be assessed and recorded continuously, with explicit querying during all follow-up visits.
Treatment duration
Operationalisation (measurement variable):
The dates of diagnostic, study, and treatment milestones will be recorded in the eCRF. Time intervals expressed in days, will be assessed for:
- Randomisation to last study treatment (LST)
- Randomisation to oncological breast surgery
- Oncological breast surgery to last study treatment (LST)
Analysis metric:
The 'randomisation to last study treatment (LST)' time interval, expressed in days.
Method of aggregation:
KM-estimates and derived estimates for central tendency and spread will be provided. For comparisons and estimands, please refer to the SAP
Measured: These outcome variables will be continuously recorded as the participant progresses through the study and the data is entered in the eCRF.
Pathological complete response rate (pCR)
Operationalisation (measurement variable):
Patients receiving preoperative therapy undergo pathological response assessment of the removed breast tissues (SoC assessment). The reported response Pinder-classification or 'No preoperative therapy' will be recorded in the eCRF.
Analysis metric:
The response category as described in the pathology report will be recorded for all participants, but this outcome will only be assessed in participants receiving preoperative-systemic therapy (with, or without Preop-RT).
This is due to the fact that no response is expected at 2-6 weeks after radiation therapy monotherapy, which would result in an unfair comparison.
Both this subset of the ITT set, and the complete safety set will be used in the safety assessment, as described in the SAP.
Method of aggregation:
The frequency and proportion of the response categories will be presented in a table. For comparisons and estimands, please refer to the SAP.
Measured: This outcome variable will be assessed after the pathology report of the removed breast tissues is available. This is checked intermittently during the treatment phase, or at least during the 3 months follow-up visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2024
- Study start20 Feb 2025
- Primary completion20 Feb 2029 (estimated)
- Study completion20 Feb 2038 (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 NeoplasmsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter phase 3 (non-pharmacological) randomized controlled trial, with a parallel design and a 1:1 assignment ratio.
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Research Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Ziekenhuis aan de Stroom, Iridium netwerk
- Responsible party
- Sponsor
- Investigators
- Melanie Machiels, MD, PhD, Principal investigator, Iridium netwerk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06739655
- Sponsor's protocol ID
- CTO23023GZA
- Acronym
- PRADAIIBE
- Status last verified
- Feb 2026
- First submitted
- 2 Dec 2024
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data generated during this study will be anonymised and then shared with the UK based PRADA-consortium and the Dutch BRENAR study (parallel pilot study). This PRADA-consortium oversees the organisation of similar trials in other countries, with the goal of publishing the results from these international studies as pooled data in order to increase the sample size and thereby the statistical power of the conclusions. Special care will be taken to anonymise all personal data and to adhere with both Belgian and European data protection and privacy laws (GDPR).
Publications
Quisenaerts T, Van Der Auwera I, Poortmans P, Reynders D, Van Dieren L, Thiessen F, Amajoud Z, Tondu T, Punie K, Tjalma W, Van Berckelaer C, Kindts I, Remouchamps V, Depypere B, Machiels M. Preoperative Radiation Therapy and Immediate Breast Reconstruction, a phase 3 randomized controlled trial in the Belgian population (PRADAIIBE): a study protocol. BMC Cancer. 2026 Apr 27;26(1):743. doi: 10.1186/s12885-026-16071-6.
PubMed 42046025
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Radiation Therapy and Immediate Breast Reconstruction, a Phase 3 Randomized Controlled Trial in the Belgian Population
- ClinicalTrials.gov ID
- NCT06739655
- Acronym / sponsor ID
- PRADAIIBE / CTO23023GZA
- Conditions
- Breast Neoplasms, Breast Carcinoma, Breast Adenocarcinoma, Cancer, Neoplasm
- Keywords
- Breast cancer, Radiotherapy, PRADA, Breast reconstruction, BreastQ, QoL, Skin Sparing Mastectomy, Mastectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Cancer Research AntwerpUniversity, hospital or other
- Collaborators
- Ziekenhuis aan de Stroom, Iridium netwerk
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 20 Feb 2029 (estimated)
- Study completion
- 20 Feb 2038 (estimated)
- First posted
- 18 Dec 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.
The goal of this phase III randomized controlled trial (PRADAIIBE) is to assess if preoperative radiation therapy (Preop-RT) combined with immediate breast reconstruction (IBR) can safely improve both aesthetic and quality of life outcomes in breast cancer patients, compared to the standard of care (SoC) therapy consisting of post-mastectomy radiation therapy (PMRT) and delayed/immediate breast reconstruction, in a population of breast cancer patients with an indication of mastectomy and PMRT.
The following hypotheses and outcomes will be assessed at the primary endpoint of 1 year of follow-up:
- Efficacy: Does Preop-RT+IBR lead to a higher BREAST-Q satisfaction with breasts score (primary endpoint), EQ-5D-5L VAS score , EQ-5D-5L Index score, AIS-Total Aesthetic Score, or a shorter treatment duration compared to SoC?
- Safety: Does Preop-RT+IBR lead to an increase in adverse events (general or surgical), a lower rate of pathologic Complete Response (pCR), or worse survival outcomes compared to SoC? [Note: this study was not powered as a non-inferiority trial, all outcomes will be pooled internationally with parallel studies]
Eligible and consenting participants will undergo screening and baseline assessments. They will then be randomised between experimental (Preop-RT+IBR) and control (SoC) groups, in a 1:1 stratified variable block size design. Follow-up will take place at 3 months, 1, 2, 5, and 10 years after the last study treatment. At baseline and during each follow-up visit each participant will complete the Breast Q 'satisfaction with breasts' and EQ-5D-5L scales, photographs will be taken. During follow-up pCR will be assessed if applicable, adverse events will be registered, and oncological follow-up will be recorded.
Detailed description
The PRADAIIBE study is a multicentric phase III randomized controlled trial, investigating the effects of radiation therapy timing on breast reconstruction results in breast cancer patients.
This study will recruit adult female breast cancer patients from the Belgian population, who have an indication for mastectomy, Post-Mastectomy Radiation Therapy (PMRT), and also have a wish for breast reconstruction.
After informed consent is signed, patients will be screened, and included in the study if all eligibility criteria are met. If they are not eligible for participation or choose to withdraw after the ICF was signed, they will be registered as a 'screen failure'.
After study inclusion, baseline assessments take place, this includes two questionnaires, one focussed on patient's satisfaction with their own breasts (BREAST-Q v2, BQ-score), the other one focussed on their quality of life perception (EQ-5D-5L VAS-score and Index-score). Next, four photographs of the exposed breast area will be taken. These photographs will later be assessed by an expert panel (AIS-TAS).
Eligible participants are randomized using the central eCRF randomization tool (Castor EDC). Randomisation is stratified on study site and a variable block size will be used. Resulting in random assignment to one of the following treatment arms:
- Control (SoC) treatment arm: Mastectomy followed by PMRT and delayed (or immediate) breast reconstruction.
- Experimental treatment arm: preoperative radiation therapy (preop-RT) followed by mastectomy and immediate breast reconstruction.
Those assigned to the control group will follow the standard of care (SoC) treatment consisting of oncological surgery (within 6 weeks of randomisation or end of preop chemotherapy) followed by radiation therapy (PMRT) within 6-12 weeks. The breast reconstruction surgery will take place either at the same time (e.g. tissue expander implantation) as the oncological surgery, or at a delayed moment (usually a 6-12 months delay).
Patients assigned to the intervention group will receive preop-RT (within 6 weeks of randomisation or end of preop chemotherapy), and after an interval of 2-6 weeks mastectomy combined with immediate breast reconstruction will be performed. The radiation therapy will be administered according to the same principles as PMRT/Whole Breast Radiation Therapy (WBRT). This change to preoperative timing of the radiation therapy allows for immediate breast reconstruction without irradiation of the reconstructed breast.
In the unexpected event of tumour downstaging due to preoperative treatment, changing the indication from mastectomy to breast conserving surgery (BCS), while the patient has already been included, it is allowed within the study protocol to perform BCS. In this case the patient should receive the treatment and surgery which is in their best interest. The same follow-up will be provided. In statistical analysis results from such patients will be handled according to the inter-current events (ICE) strategies defined in the SAP. However, such downstaging is not expected from preop-RT at such a short treatment interval of 2-6 weeks.
Systemic therapy will be administered per standard of care, according to the discretion of the treating medical oncologist. Systemic therapy details will be registered in the eCRF, but it is not considered as part of the study treatments, and will not be manipulated within this trial.
After the treatment period is finished (last study treatment) follow-up will take place at 3 months, 1 year, 2 years, 5 years and 10 years. In the control group, patients undergoing delayed breast reconstruction will be invited to an intermediate follow up visit (IMFU) visit at 3 months after conclusion of radiation therapy. The reason for this IMFU visit is to capture the outcomes of interest in the interval between mastectomy and breast reconstruction, as well as provide continued study follow-up during this long treatment interval of +/- 6-12 months.
During each follow-up visit the BREAST-Q and EQ-5D-5L questionnaires will be assessed, photographs will be taken and evaluated at a later (expert panel using the AIS-tool), adverse events will be elicited, pathologic response assessed, treatment milestones are recorded (treatment duration) and oncological recurrence is assessed from the +1 year visit onwards according to the events and outcomes described in the DATECAN 2015 initiative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter phase 3 (non-pharmacological) randomized controlled trial, with a parallel design and a 1:1 assignment ratio.
| Arm | Type | Receives |
|---|---|---|
| Standard treatment arm (SoC; PostOperative RT) | Active comparator | Radiation: Postoperative radiotherapy, Procedure: Immediate or delayed breast reconstructionTreatment in this arm consists of: 1. Mastectomy 2. Immediate or delayed breast reconstruction. 3. Postoperative radiation therapy, according to the SoC as indicated by international guidelines. [Systemic treatments are not considered as study treatments and will be implemented at the discretion of the treating physician.] |
| Experimental treatment arm (PreOperative RT) | Experimental | Radiation: Preoperative radiotherapy, Procedure: Immediate breast reconstructionTreatment in this arm consists of: 1. Preoperative radiation therapy (Preop-RT). Preop-RT will be administered according to the same parameters and quality standards as PMRT/WBRT, as indicated by international guidelines. 2. Mastectomy combined with immediate breast reconstruction, after a 2-6 weeks interval. [Systemic treatments are not considered as study treatments and will be implemented at the discretion of the treating physician.] |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- In order to be eligible to participate in this study, a participant must meet all of the following criteria:
- 1.a. require SSM/NSM for any reason (e.g. extensive disease)
- 1.b. require postoperative radiation therapy of at least the chest wall
- c. have a wish for a breast reconstruction
- An Eastern Cooperative Oncology Group (ECOG) performance status grade ≤ 2
Key exclusion criteria (8 listed)
- A potential participant who meets any of the following criteria will be excluded from participation in this study:
- A previous history of breast cancer or irradiation of the chest wall for any other indication, on the other side (ipsilateral). A bilateral SSM/NSM + reconstruction (e.g. in case of a contralateral prophylactic SSM/NSM), or previous contralateral breast cancer disease/treatment, do not fall under this criterium and are thus allowed.
- Collagen synthesis disease
- Ongoing pregnancy
- Actively breastfeeding
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 radiotherapyAlso: Preop-RT, Neoadjuvant radiation therapy, NARTIn this study patients assigned to the experimental treatment arm will receive preoperative radiation therapy instead of postoperative radiation therapy (PMRT). This preoperative radiation therapy will be administered according to the standard of care (SoC) principles for PMRT and Whole Breast Radiation Therapy (WBRT) as defined by international guidelines. | Radiation | Experimental treatment arm (PreOperative RT) |
| Postoperative radiotherapyAlso: Postop-RT, Postmastectomy Radiation Therapy, PMRT, Adjuvant Radiation TherapyStandard of care (SoC) postoperative radiotherapy, as defined by international guidelines. | Radiation | Standard treatment arm (SoC; PostOperative RT) |
| Immediate breast reconstructionAlso: IBRIn the experimental arm of the PRADAIIBE, the participants will undergo immediate breast reconstruction surgery. This is defined as breast reconstruction taking place at the same time as oncological surgery. Using one of the following primary techniques: 1) Autologous tissue reconstruction ; 2) Breast implant based reconstruction; 3) Combined autologous tissue and breast implant reconstruction. These techniques can take place in a single phase, or in a two-phased (tissue expander) approach. Adjuvant techniques (e.g.: lipofilling, mesh, ADM etc.) could be added. | Procedure or surgery | Experimental treatment arm (PreOperative RT) |
| Immediate or delayed breast reconstructionIn the standard arm of the PRADAIIBE, the participants will undergo immediate or delayed breast reconstruction surgery. This is defined as breast reconstruction taking place at the same time as oncological surgery (immediate), or at a later time (delayed). Using one of the following primary techniques: 1) Autologous tissue reconstruction ; 2) Breast implant based reconstruction; 3) Combined autologous tissue and breast implant reconstruction. These techniques can take place in a single phase, or in a two-phased (tissue expander) approach. Adjuvant techniques (e.g.: lipofilling, mesh, ADM etc.) could be added. | Procedure or surgery | Standard treatment arm (SoC; PostOperative RT) |
Primary outcome
Patient's satisfaction with breasts.
Time frame: Measured at 3 months, 1year, 2 years, 5 years and 10 years after last locoregional treatment. Primary endpoint: 1 year after LST.
Operationalisation (measurement variable): The satisfaction with breasts outcome variable is operationalised through the "satisfaction with breasts" scale from the BREAST-Q (v2) 'Reconstruction', 'Breast Conserving Treatment', or 'Mastectomy' modules (as applicable). The answers from the questionnaire are then transformed into a 'BREAST-Q Score', using the provided conversion scales.(3) The BREAST-Q score can range from 0 to100. Analysis metric: The transformed value of the BREAST-Q score will be used for analysis. Method of aggregation: Mean, SD, median, IQR, and range will be reported. For comparisons and estimands, please refer to the SAP.
7 secondary outcomes
Quality of Life (EQ-5D-5L VAS score)
Time frame: A baseline assessment is performed during the screening visit, followed by repeated measurements during the IMFU (if applicable), 3M, 1Y, 2Y, 5Y, and 10Y follow-up visits.
Quality of Life (Index score)
Time frame: A baseline assessment is performed during the screening visit, followed by repeated measurements during the IMFU (if applicable), 3M, 1Y, 2Y, 5Y, and 10Y follow-up visits.
Breast cosmesis, objective assessment (AIS - TAS)
Time frame: Photographs are taken during the screening visit, followed by repeated photographs during the IMFU (if applicable), 3M, 1Y, 2Y, 5Y, and 10Y follow-up visits. Expert panel assessment will take place at a later moment.
Frequency and severity of adverse events (General AEs)
Time frame: AEs will be assessed and recorded continuously, with explicit querying during all follow-up visits.
Frequency and severity of adverse events (Surgical AEs)
Time frame: AEs will be assessed and recorded continuously, with explicit querying during all follow-up visits.
Treatment duration
Time frame: These outcome variables will be continuously recorded as the participant progresses through the study and the data is entered in the eCRF.
Pathological complete response rate (pCR)
Time frame: This outcome variable will be assessed after the pathology report of the removed breast tissues is available. This is checked intermittently during the treatment phase, or at least during the 3 months follow-up visit.
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 4 Feb 2026.
- Derived from this study: PubMed 42046025Quisenaerts T, Van Der Auwera I, Poortmans P, Reynders D, Van Dieren L, Thiessen F, Amajoud Z, Tondu T, Punie K, Tjalma W, Van Berckelaer C, Kindts I, Remouchamps V, Depypere B, Machiels M. Preoperative Radiation Therapy and Immediate Breast Reconstruction, a phase 3 randomized controlled trial in the Belgian population (PRADAIIBE): a study protocol. BMC Cancer. 2026 Apr 27;26(1):743. doi: 10.1186/s12885-026-16071-6.
- Individual participant dataSharing planned: Yes. All data generated during this study will be anonymised and then shared with the UK based PRADA-consortium and the Dutch BRENAR study (parallel pilot study). This PRADA-consortium oversees the organisation of similar trials in other countries, with the goal of publishing the results from these international studies as pooled data in order to increase the sample size and thereby the statistical power of the conclusions. Special care will be taken to anonymise all personal data and to adhere with both Belgian and European data protection and privacy laws (GDPR).
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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.
Melanie Machiels, MD, PhD principal investigator
Iridium netwerk
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative radiotherapy, Postoperative radiotherapy and Immediate breast reconstruction in people with Breast Neoplasms and Breast Carcinoma, run by Cancer Research Antwerp at 6 sites in Belgium.
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 7 inclusion and 8 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 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium. 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 Tom Quisenaerts, MD (+3234433759 ext. +32, Tom.quisenaerts@zas.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient's satisfaction with breasts. (time frame: Measured at 3 months, 1year, 2 years, 5 years and 10 years after last locoregional treatment. Primary endpoint: 1 year after LST.). 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 NCT06739655, 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 4 Feb 2026; AzTrials last refreshed its copy on 1 Nov 2026.