PartBreCon-Pro Study: PARTial BREast RECONstruction With Chest Wall Perforator Flap, a PROspective Study of Clinical and Patient Reported Outcomes
Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Carcinoma, Breast Neoplasms, Breast Surgery, Breast Reconstruction Surgery
Sponsor: Cambridge University Hospitals NHS Foundation Trust

PartBreCon-Pro study_Protocol_v.4.1 
 
1 
 
 
 
The PartBreCon-Pro Study 
 
PartBreCon-Pro Study: - A multi-centre PROspective study, 
including PROMS of PARTial BREast ReCONstruction with chest wall 
perforator flap 
 
A BreCon project 
 
A prospective multicentre cohort study to evaluate the clinical and 
patient-reported outcomes following breast-conserving surgery and 
partial breast reconstruction with chest wall perforator flap  
 
Study contact: partbrecon.pros@gmail.com 
 
A study by the Breast Consortium (BreCon)  
 
 
 
 
Study Protocol  
Version 4.1 
 
October 2023 
 
 
 
 
 
 

PartBreCon-Pro study_Protocol_v.4.1 
 
2 
Table of Contents 
1 
Background ...............................................................................................................3 
1.1 
Chest Wall perforator flap ............................................................................................. 3 
1.2 
The impact of radiotherapy on surgical and patient-reported outcomes ......................... 3 
1.3 
PROMS in Breast Conserving Surgery and CWPF ............................................................. 4 
2 
Methods ....................................................................................................................5 
2.1 
Study Design ................................................................................................................. 5 
2.2 
Aims ............................................................................................................................. 5 
2.3 
Objectives ..................................................................................................................... 5 
2.4 
Main Outcomes and Measures ...................................................................................... 6 
2.5 
Outcome Conclusions .................................................................................................... 7 
2.6 
Setting, Participants and Exposure ................................................................................. 7 
2.7 
Inclusion and Exclusion criteria ...................................................................................... 7 
2.8 
Study Duration .............................................................................................................. 8 
2.9 
Surgical Technique ........................................................................................................ 8 
2.10 
Data Management ........................................................................................................ 8 
2.11 
Clinical Governance ..................................................................................................... 10 
2.12 
Statistical Methods ..................................................................................................... 10 
3 
Dissemination .......................................................................................................... 11 
3.1 
Dissemination ............................................................................................................. 11 
3.2 
Publication and Authorship Policy................................................................................ 11 
4 
Study Expertise ........................................................................................................ 12 
5 
Log of Protocol changes ........................................................................................... 12 
6 
APPENDICES ............................................................................................................ 12 
6.1 
Table 1: PartBreCon-Pro Study Dataset ........................................................................ 12 
6.2 
Enclosures ................................................................................................................... 12 
7 
REFERENCES............................................................................................................. 13 
 
 
 
 

PartBreCon-Pro study_Protocol_v.4.1 
 
3 
1 Background 
 
1.1 Chest Wall perforator flap  
Surgery remains the primary treatment for early breast cancer, with 7-8 out of 10 women with 
breast cancer undergoing breast conservative surgery (BCS) 1. Although effective for smaller 
tumours, poor aesthetic outcomes after BCS can lead to adverse patient-reported outcomes for 
some patients, such as distorted body image, negative self-esteem, and loss of confidence in 
psychosocial and sexual settings 2. Further, complications can worsen aesthetic outcomes 3,4 and 
patient experience following necessary radiotherapy 5,6.  
Oncoplastic breast conservative surgery aims to ensure complete oncological resection whilst 
maintaining or improving current breast aesthetics. Oncoplastic techniques have evolved and 
expanded over the last 15-20 years, including volume replacement techniques of chest wall 
perforator flaps (CWPF) in partial breast reconstruction. Hamdi et al. described using these flaps in 
partial breast reconstruction in 2004 7. These versatile flaps are useful to replace breast volume loss 
of up to 30%, especially in small to medium-sized breasts (up to size C or D European Bra cup size), 
to avoid mastectomy for similar size tumours due to the relative lack of remaining breast volume 
following tumour excision. 
CWPF surgery is an improvement over BCS and partial breast reconstruction techniques that used a 
strip of back muscle (Latissimus Dorsi, LD) 8,9 and resulted in more post-operative pain, longer 
hospital stays, longer recovery time and some compromise of shoulder function 10.  
 
Although described a decade ago, the use of perforator flaps in volume replacement has increased 
only over the last few years. Evidence in the literature is based on small case series with relatively 
low volume experience and limited outcomes 11-15. A systematic review 16 showed low complication 
rates. However, it included studies that had non-concordant datasets with variable follow-up. A 
large multi-centre series (15 UK centres, n = 507) by this BreCon collaborative17 showed low 
complication rates (30-day haematoma, 4.3%; infection, 4.3%; delayed wound healing, 2.8% and 
0.6% flap loss leading to readmissions in 2.6% and re-operations in 2.6%. However, the series is 
retrospective, with no PROM data and inadequate data on radiotherapy, which can influence 
aesthetic outcomes and, consequently, PROMs. 
 
1.2 The impact of radiotherapy on surgical and patient-reported outcomes 
                                                                                                                                                                             
There needs to be more trial data on the effect of radiotherapy on outcomes following OBS, 
including in the CWPF 3. Before OBS, unrepaired defects following BCS filled with seroma (wound 
fluid). When the seroma resolved, the operated area used to deform with significant scarring that 
worsened with radiotherapy, leading to poorer outcomes evident in many radiotherapy studies 3. 
Most radiotherapy trials will not have included these newer OBS procedures 3,18. 
Any robust prospective surgical database needs to include radiotherapy data since this influences 
the post-operative condition of the breasts and, in turn, impacts both surgical and patient-reported 

PartBreCon-Pro study_Protocol_v.4.1 
 
4 
outcomes. For example, some patients need an extra dose (boost dose) to the original tumour bed 
in addition to standard whole-breast radiotherapy. An initial retrospective report attempted to 
understand the nuances of radiotherapy planning in CWPF and highlighted the complexities 19.  
A recent literature review on boost radiotherapy reveals a lack of boost data in partial breast 
reconstruction, i.e., replacement type of oncoplastic breast surgery 20.  
Therefore, it is necessary to audit radiotherapy data  
• 
To better understand planning consistency, which is essential for oncological safety 
• 
To ascertain the impact of radiotherapy on cosmetic outcomes following OBS  
 
Additionally, analysis of robust outcome data may provide insights that can lead to future 
radiotherapy trials within OBS in a truly multi-disciplinary approach 21.  
1.3 PROMS in Breast Conserving Surgery and CWPF  
                                                                                                                                                                                   
It is estimated that at least two-thirds of women following treatment for breast cancer will live 
beyond 15 years. Whilst interrelated with clinical outcomes, a patient’s perception and satisfaction 
with their cancer treatment include elements beyond objective clinical measures of survival or 
function. The desired aesthetic outcome is vital for these women's QoL considerations (body 
confidence, psychosocial and psychosexual health) to allow them to lead a ‘new normal’ life. 
Therefore, patient-reported outcomes (PROs) are vital to demonstrating cancer treatment success. 
The UK NCRI Living With and Beyond Cancer Group have identified short- and long-term effects and 
psychological impact among research priorities 22.  
There has been a growing use of PROMs in health care over the last 20 years 23. Routine use provides 
an opportunity to help drive changes in how health care is organised and delivered 24. PROMs are 
routinely used to monitor elective surgery. A systematic review 25 identified two validated PROMs 
specifically for breast cancer surgery (BIBCQ and Breast-Q). BIBCQ does not address any aesthetic 
issues after breast reconstruction. Although Breast-Q has individual modules for BCS and LD surgery, 
it does not address outcomes specific to CWPF. 
 
Breast-Q (©2017, Memorial Sloan Kettering Cancer Centre and the University of British Columbia) is 
a commonly used validated psychometrically developed and validated multiscale, multimodule tool 
for Patient Reported Outcomes Measures (PROMs) for oncoplastic and reconstructive breast surgery 
26,27. Breast-Q provides scores ranging from 0-100, with 100 being the highest in both patient 
satisfaction and Quality of Life (QOL) domains.  
Due to a lack of specific PROMS in CWPF, after due licence-holder permission, a combination Breast-
Q (combined Breast Conserving Therapy, BCT and Latissimus Dorsi flap, LD modules) has been used 
following CWPF 28,29. Two University hospitals explored the combination of Breast-Q’s BCT and LD 
flap modules 30. The baseline data from 36 patients, 6-12 months after radiotherapy, revealed a 
minimum of 80% patient satisfaction in all domains with two lower-scoring domains: sexual 60% and 
physical well-being 76%. The LD module showed 90% satisfaction with the back appearance and 77% 
with shoulder and back function.  

PartBreCon-Pro study_Protocol_v.4.1 
 
5 
 
The lack of pre-operative baseline data, small numbers, and the absence of patient demographics, 
disease, and treatment data limits the interpretation. However, without specific CWPF PROMs, they 
show the feasibility of combining Breast-Q’s Breast Conserving Therapy module and the back sub-
scale of the LD flap module for CWPF. Also, the current Breast-Q LD flap module studies complete 
back muscle (LD) use for full breast reconstruction following total mastectomy (and not BCT). 
However, CWPF does not use muscle. 
Therefore, the evidence gap needs addressing to establish outcomes standards commensurate with 
current and increasing ‘replacement’ procedure options that improve women's choices.  
 
2 Methods  
 
2.1 Study Design  
 
A non-interventional observational multicentre prospective cohort study  
 
2.2 Aims  
 
This multicentre prospective cohort study aims to evaluate the surgical outcomes of CWPF partial 
breast reconstructions following breast-conserving surgery for early breast cancer. This project aims 
to create a performance standard for CWPF procedure based on robust, reliable, and valid data. 
Therefore, a prospective, representative dataset is needed from which to extract reliable and valid 
statistical distributions that show: 
1. 
The impact of surgery on the clinical outcome.  
2. 
The impact of radiotherapy on the clinical outcome 
3. 
Patient Reported Outcome Measures (PROMs)  
 
2.3 Objectives 
 
Aims will be achieved in three parts of the audit: 
 
Part A: Surgical treatment dataset 
Part B: Oncological treatment dataset 
Part C: PROMS (Optional) 
 
 
 
 
 
 

PartBreCon-Pro study_Protocol_v.4.1 
 
6 
Part A: Surgical treatment dataset 
 
It will include surgical variables that can be prospectively fed into the RedCapTM database and 
maintained prospectively, including surgical outcomes at 30 days (in line with NHS Health Episode 
Statistics) with determination and analysis of  
- 
Patient demographics, tumour, and surgical characteristics  
- 
Complications rate and types 
- 
Re-excision rates   
 
Part B: Oncological treatment dataset 
 
It would be the audit dataset that all centres are encouraged to work with their Oncology colleagues 
in a multi-disciplinary fashion to collate oncological treatment records, specifically radiotherapy 
data, to inform the consistency of oncological therapies and outcomes.  
 
Part C: PROMS  
PROMS (Breast-Q’s BCT and LD flap back modules will be given pre-operatively and 6 months after 
radiotherapy. In addition, the DASH (Disability of Arm, Shoulder and Hands) questionnaire for 
shoulder function. Those centres using PROMS are requested to complete this component, too. 
However, centres not using PROMS in their routine practice cannot audit this component (Part C). 
Once patients return the PROMs Scores, they must be inputted into the database.  
 
2.4 Main Outcomes and Measures 
A) Patient Demographics and Tumour characteristics 
1. Patient demographics: age, body mass index (BMI), comorbidities  
2. Preoperative tumour characteristics and location influencing surgical planning 
 
B) Treatment characteristics  
1. Surgical: operative data, including flap types and distribution 
2. Oncological: systemic therapies (adjuvant and neoadjuvant), radiotherapy  
 
C) Primary outcome: Surgical  
1. Complications 
2. Oncological clearance: Re-excision rates, conversion to mastectomy 
 
D) Secondary outcomes 
1. Revisional surgery 
2. Surveillance 
3. Oncological: Recurrence and Mortality 
 
E) Patient-reported outcomes 
1. Pre-operative  
2. Post-operative (pre-radiotherapy) 
3. Post-radiotherapy (6 months)  

PartBreCon-Pro study_Protocol_v.4.1 
 
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2.5 Outcome Conclusions 
 
• 
It will be the first prospective audit of CWPF practice; it will provide a baseline for re-audits  
• 
Shared learning experience leading to an improvement in practice 
• 
Patient feedback will lead to improvement  
 
2.6 Setting, Participants and Exposure 
 
Each surgeon in each centre should have performed 10 CWPF cases to demonstrate experience 
beyond the early learning phase that could influence surgical outcomes. Each centre anticipates that 
approximately 10 CWPF Patients will be performed each year.  
Patients would have been offered all options (simple wide local excision, therapeutic mammaplasty, 
mastectomy with or without immediate whole breast reconstruction) in keeping with UK oncoplastic 
guidelines 31. We will collect data on consecutive patients in each centre according to the 
prospectively maintained local database on CWPF surgery, and this will reduce selection bias. 
PROMs: They will be given pre-operatively and 6 months following radiotherapy (please see 
enclosed pre-operative and post-operative versions). Therefore, the earliest post-operative PROMs 
is expected from March 2024, and the latest will be January 2026 to allow for the completion of the 
following: 
- 
Adjuvant radiotherapy only: standard commencement within 3 months and up to 4 weeks 
duration 
- 
Adjuvant chemo-radiotherapy: Standard commencement is within 3 months and usually 
extends over 9 months. 
 
2.7 Inclusion and Exclusion criteria  
 
Inclusion criteria: 
- 
Patients undergoing partial breast reconstruction using CWPF for primary breast cancer  
- 
Delayed correction of breast deformity following previous BCS 
- 
Each surgeon is to have performed a minimum of 10 CWPFs   
- 
Each centre anticipates completing a minimum of 10/year 
 
Exclusion criteria:  
- 
Patients undergoing volume displacement BCS 
- 
Patients undergoing mastectomy +/- immediate breast reconstruction 
 
 

PartBreCon-Pro study_Protocol_v.4.1 
 
8 
2.8 Study Duration 
 
Audit duration: 36 months (01 June 2023 – 31 May 2026)  
Audit entry period: 24 months (01 June 2023 – 31 May 2025) – all patients who undergo CWPF 
during this period. 
Data lock and cleaning: 2 months (01 March 2026 – 30 April 2026) 
Data analysis: 1 month (01 May 2026 – 31 May 2026)  
 
2.9 Surgical Technique 
 
According to the published anatomical landmarks and operative steps, CWPF surgery will be 
performed either by an oncoplastic breast surgeon alone or jointly with a plastic surgeon 7,11,32,33. In a 
single-stage procedure, once the cancer resection is completed, the CWPF can be raised as a 
turnover flap (folded 180o), a pendulum type flap based on longer pedicles (TDAP/LTAP) or a 
propeller flap (with skin replacement), to reconstruct the tumour excision defect.  
A drain could be used based on individual intra-operative circumstances (e.g., simultaneous axillary 
node clearance). If used, this will usually be placed across the donor site and the breast cavity. 
Alternatively, patients may undergo a ‘two-stage’ approach if there is a pre-operative concern 
regarding achieving clear margin status (e.g., pure DCIS or invasive lobular cancer). This latter 
approach usually involves initial cancer resection, filling the resection cavity with water/saline. 
Patients return within 4-6 weeks for second-stage partial breast reconstruction 15.  
UK Association of Breast Surgery consensus in 2015 adopted and accepted 1mm tumour resection 
margin for both invasive and in-situ disease 34. Individual centres’ policies should be reasonably 
consistent with or without local MDT amendments. Each centre will record the margin distance and 
whether that is deemed clear or positive following the MDT discussion.  
2.10 Data Management 
                                                                                                                                                                              
Each centre lead will acquire local clinical governance authority approval to collect anonymised data 
relevant to the study objectives prospectively. Agreed Protocol-based data variables will then be 
entered securely and accurately into the secure IG-approved central RedCap database. Centres, 
while awaiting database access, can enter data prospectively into a locally stored Microsoft Excel 
sheet (and move data later to the central database). RedCap will automatically allocate a study 
identification number. In the local spreadsheet, centres will enter patient data with a study 
identification number. The identification number will be the first letters of the name of the 
hospital (e.g., Royal Breast Hosp = RBH) with the patient number in order of study entry (001 and 
so forth. Each participant will then be RBH001, RBH002, and so on. This will allow for cross-
checking data, which may be necessary, per Caldicott’s principles (2013). No identifiable patient data 
will be centrally submitted or stored. 

PartBreCon-Pro study_Protocol_v.4.1 
 
9 
Part A: Surgical treatment dataset 
 
This primary dataset will include surgery-related variables that will be prospectively fed into the 
database and maintained prospectively, including surgical outcomes at 30 days (in line with NHS 
Health Episode Statistics).  
 
Part B: Oncological treatment dataset 
 
This would be the dataset that all centres are encouraged to work with their Oncology colleagues in 
a multi-disciplinary fashion to collate oncological treatment records, specifically radiotherapy data 
(variables in Table 1). The routine practice variables include RT fractions and volume data:  
1. Gross Tumour Volume (GTV) is the gross demonstrable tumour volume.  
2. Clinical Tumour Volume (CTV) contains the GTV plus a margin for sub-clinical disease.  
3. Planning Target Volume (PTV) is the geometrical planning to ensure that radiotherapy 
includes CTV. 
 
A surgical trainee participating in this audit may sit with an Oncological trainee during RT planning 
for learning. In that case, it will foster mutual understanding and data sharing and, in the future, 
improve MDT interaction for better patient care. 
 
Part C: PROMS  
 
Those centres using PROMS are requested to complete this component, too. However, centres must 
already use PROMS in their routine practice to audit this component (Part C).  
 
PROMS are to be given pre-operatively and 6 months after radiotherapy. We will use the following 
well-validated PROMs instruments, Breast-Q and QuickDASH (enclosed): 
1. Breast-Q’s Breast Conserving Therapy module  
2. Back sub-scale of the LD flap module 
3. QuickDASH (Disabilities of the Arm, Shoulder, and Hands) questionnaire 
 
All PROMs will be given to the patient in paper format, and Response copies will be stored securely 
at each centre. Response variables must be inputted anonymously (linked with patient study ID) into 
the RedCap database for central analysis. For use outside this audit, if not already in the centre’s 
routine use, each centre must apply for licencing. Both questionnaires are on public domains and are 
available for routine patient care. We encourage all centres to use PROMs in their everyday practice, 
too.  
The application process for a licence is straightforward at the links below and is free to non-profit 
users for use in clinical practice. Please note that support is not free for non-academic use.  
- 
Breast-Q (©2017, Memorial Sloan Kettering Cancer Centre and the University of British 
Columbia; https://qportfolio.org/breast-q/breast-cancer/) and  
- 
QuickDASH (©Institute for Work & Health 2006-2020, Toronto, Canada; 
https://dash.iwh.on.ca/about-quickdash ) 
 
 

PartBreCon-Pro study_Protocol_v.4.1 
 
10 
2.11 Clinical Governance 
 
Data will be analysed after the evaluation to determine uptake, response rates and surgical 
outcomes. Data for individual centres will be evaluated, compared with the average measures (from 
this study itself) and fed back to individual participating units. Local collaboratives and hospitals will 
own their data at the end of the evaluation and after analysis and can present it locally if they wish. 
 
2.12 Statistical Methods 
 
Data will be analysed within the RedCap and further examined using the statistical software RTM 
(version 4.1.1 or later) or another software if deemed necessary by the study statistician. Descriptive 
statistics for each variable will include counts and percentages of categorical data, whereas median 
and inter-quartile range (IQR) will be calculated for continuous data. Statistical significance will be 
determined using standard Wald tests and the default method in the RTM. Shapiro-Wilk test will be 
used to test for the normality of the distribution of cases across all centres.  
Multivariable logistic regression will be performed for possible predictors of postoperative events 
needing intervention (aspirable seroma and complications). A separate sensitivity analysis will be 
performed, including BMI 35 in the best-fit models. The analysis will commence using all variables 
and continue using backward elimination or forward selection as appropriate, removing or selecting 
variables aiming for the model with the best Akaike information criterion (AIC). The AIC is chosen as 
a criterion that deals with the risk of overfitting (by penalising the number of variables selected) and 
underfitting by performing a trade-off between the model's goodness of fit. Also, the model chosen 
by leave-one-out cross-validation is asymptotically equivalent to the model selected by AIC. AIC is 
primarily used in cases where the goal is prediction.  
 
Breast-Q’s scoring software, Q-score, provides enumerated scores from 1-100, with the lowest being 
the worst and 100 being the best. QuickDASH has a quick online calculation facility on the following 
link: 
http://www.orthopaedicscore.com/scorepages/disabilities_of_arm_shoulder_hand_score_quickdas
h.html. 
 
The study will be reported per the Strengthening the Reporting of Observational Studies in 
Epidemiology (STROBE) guidelines 36.  
 
 
 
 
 
 
 
 

PartBreCon-Pro study_Protocol_v.4.1 
 
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3 Dissemination 
 
3.1 Dissemination  
Study outcomes will be disseminated via 
• 
National and international scientific conferences 
• 
Publication in peer-reviewed journals (3-4 scientific papers) 
• 
Patient voices (including Independent Cancer Patients’ Voice, NCRI consumer forum), social 
media. 
3.2 Publication and Authorship Policy 
 
The ‘Breast Consortium (BreCon)’ will make all references and outputs. The levels of authorship will 
be according to the International Committee of Medical Journal Editors (ICMJE) - 
https://www.icmje.org/recommendations/browse/roles-and-responsibilities/defining-the-role-of-
authors-and-contributors.html    
 
Authorship  
The ICMJE recommends that authorship be based on the following 4 criteria: 
• Substantial contributions to the conception or design of the work or the acquisition, analysis, 
or interpretation of data for the work; AND 
• Drafting the work or revising it critically for important intellectual content AND 
• Final approval of the version to be published AND 
• Agreement to be accountable for all aspects of the work in ensuring that questions related 
to the accuracy or integrity of any part of the work are appropriately investigated and 
resolved. 
Therefore, the anticipated Authorship will include the Principle and Co-Principle Investigator, the 
Steering Committee, and the Main Statistician.  
 
Acknowledged Collaborators  
All sites contributing at least ten patients will be recognised in any resulting publications as PubMed-
citable co-authors. Flexible to service demands, no authorship limits will be imposed at a centre 
level, as many collaborating investigators are required, and work to support the project will be 
recognised in all future outputs. A corporate authorship model will be used.  
 

PartBreCon-Pro study_Protocol_v.4.1 
 
12 
4 Study Expertise 
The PartBreCon-Pro study has had advanced interest with support letters from many centres, 
including from surgeons who have led in CWPF surgery, that will ensure experienced conduct and 
delivery of the project.  
The Study’s Chief Investigator is Mr Amit Agrawal, Cambridge. He will oversee the central database, 
including RedCap, hosted at Cambridge University Hospitals. The current Study Steering Committee 
(Mr Amit Agrawal, Chair; Mr Laszlo Romics, Glasgow; Ms PG Roy, Oxford; Mr John Murphy, 
Manchester) will lead, coordinate, and provide this study. The committee will meet regularly and 
strategically throughout the project to advise the team on emerging findings and decisions. 
International eminent advisors include Prof M Hamdi (Plastic Surgeon, Belgium) and Prof P 
Poortmann (Oncologist, Belgium). 
 
5 Log of Protocol changes 
 
1.1 - Original (April 2023) 
1.2 2.1 - Revision (22 August 2023) 
1.3 3.1 - Revision (28 September 2023) 
1.4 4.1 – Revision (31 October 2023) 
 
 
6 APPENDICES  
 
6.1 Table 1: PartBreCon-Pro Study Dataset 
 
6.2 Enclosures 
 
1. Breast Q – BCT module 
2. Breast Q – LD flap back module 
3. QuickDASH  
 
 
 
 
 

PartBreCon-Pro study_Protocol_v.4.1 
 
13 
7 REFERENCES 
 
1. 
Association 
of 
Breast 
Surgery 
A. 
NHSBSP and 
ABS 
Audit. 
Accessed 
24.05.2020, 
https://associationofbreastsurgery.org.uk/professionals/audit/nhs-breast-screening-programme-audit/ 
2. 
Al-Ghazal SK, Fallowfield L, Blamey RW. Does cosmetic outcome from treatment of primary breast 
cancer influence psychosocial morbidity? Eur J Surg Oncol. Dec 1999;25(6):571-3. doi:10.1053/ejso.1999.0708 
3. 
Agrawal A. Oncoplastic breast surgery and radiotherapy-Adverse aesthetic outcomes, proposed 
classification of aesthetic components, and causality attribution. Breast J. 03 2019;25(2):207-218. 
doi:10.1111/tbj.13193 
4. 
Brouwers PJAM, van Werkhoven E, Bartelink H, et al. Predictors for poor cosmetic outcome in patients 
with early stage breast cancer treated with breast conserving therapy: Results of the Young boost trial. Radiother 
Oncol. 09 2018;128(3):434-441. doi:10.1016/j.radonc.2018.06.020 
5. 
Bhattacharya IS, Haviland JS, Perotti C, et al. Is breast seroma after tumour resection associated with 
patient-reported breast appearance change following radiotherapy? Results from the IMPORT HIGH 
(CRUK/06/003) trial. Radiother Oncol. 07 2019;136:190-196. doi:10.1016/j.radonc.2019.03.022 
6. 
Brouwers PJAM, van Loon J, Houben RMA, et al. Are PROMs sufficient to record late outcome of breast 
cancer patients treated with radiotherapy? A comparison between patient and clinician reported outcome 
through an outpatient clinic after 10years of follow up. Radiother Oncol. 01 2018;126(1):163-169. 
doi:10.1016/j.radonc.2017.08.004 
7. 
Hamdi M, Van Landuyt K, Monstrey S, Blondeel P. Pedicled Perforator Flaps in Breast Reconstruction: 
A New Concept. Br J Plast Surg. 2004;57(6):531-9. doi:10.1016/j.bjps.2004.04.015 
8. 
Navin C, Agrawal A, Kolar KM. The use of latissimus dorsi miniflap for reconstruction following breast-
conserving surgery: experience of a small breast unit in a district hospital. World J Surg. Jan 2007;31(1):46-50. 
doi:10.1007/s00268-006-0396-7 
9. 
Yelland A, Rainsbury D. The use of the latissimus dorsi musculocutaneous flap for immediate correction 
of the deformity resulting from breast conservation surgery. Br J Plast Surg. Jul 1999;52(5):420-1.  
10. 
Adams WP, Lipschitz AH, Ansari M, Kenkel JM, Rohrich RJ. Functional donor site morbidity following 
latissimus 
dorsi 
muscle 
flap 
transfer. 
Ann 
Plast 
Surg. 
Jul 
2004;53(1):6-11. 
doi:10.1097/01.sap.0000106430.56501.b5 
11. 
Hamdi M, Spano A, Van Landuyt K, D'Herde K, Blondeel P, Monstrey S. The lateral intercostal artery 
perforators: anatomical study and clinical application in breast surgery. Plast Reconstr Surg. Feb 
2008;121(2):389-96. doi:10.1097/01.prs.0000298317.65296.cf 
12. 
Losken A, Hamdi M. Partial breast reconstruction: current perspectives. Plast Reconstr Surg. Sep 
2009;124(3):722-36. doi:10.1097/PRS.0b013e3181b179d2 
13. 
Kim JB, Kim DK, Lee JW, et al. The usefulness of pedicled perforator flap in partial breast reconstruction 
after 
breast 
conserving 
surgery 
in 
Korean 
women. 
Arch 
Plast 
Surg. 
Jan 
2018;45(1):29-36. 
doi:10.5999/aps.2017.01200 
14. 
McCulley SJ, Schaverien MV, Tan VK, Macmillan RD. Lateral thoracic artery perforator (LTAP) flap in 
partial 
breast 
reconstruction. 
J 
Plast 
Reconstr 
Aesthet 
Surg. 
May 
2015;68(5):686-91. 
doi:10.1016/j.bjps.2015.01.008 
15. 
Roy PG, Tenovici AA. Staged approach to partial breast reconstruction to avoid mastectomy in women 
with breast cancer. Gland Surg. Aug 2017;6(4):336-342. doi:10.21037/gs.2017.03.08 
16. 
Pujji OJS, Blackhall V, Romics L, Vidya R. Systematic review of partial breast reconstruction with pedicled 
perforator artery flaps: Clinical, oncological and cosmetic outcomes. Eur J Surg Oncol. Aug 2021;47(8):1883-
1890. doi:10.1016/j.ejso.2021.03.249 
17. 
Agrawal A, Romics L, Thekkinkattil D, et al. 'PartBreCon' study. A UK multicentre retrospective cohort 
study to assess outcomes following PARTial BREast reCONstruction with chest wall perforator flaps. Breast. Jul 
17 2023;71:82-88. doi:10.1016/j.breast.2023.07.007 
18. 
Lansu JT, Essers M, Voogd AC, et al. The influence of simultaneous integrated boost, hypofractionation 
and oncoplastic surgery on cosmetic outcome and PROMs after breast conserving therapy. Eur J Surg Oncol. Oct 
2015;41(10):1411-6. doi:10.1016/j.ejso.2015.07.011 
19. 
Garreffa E, Hughes-Davies L, Russell S, Lightowlers S, Agrawal A. Definition of Tumor Bed Boost in 
Oncoplastic 
Breast 
Surgery: 
An 
Understanding 
and 
Approach. 
Clin 
Breast 
Cancer. 
Mar 
2020;doi:10.1016/j.clbc.2020.03.003 

PartBreCon-Pro study_Protocol_v.4.1 
 
14 
20. 
Garreffa E, Meattini I, Coles CE, Agrawal A. Use of tumour bed boost radiotherapy in volume 
replacement oncoplastic breast surgery: A systematic review. Crit Rev Oncol Hematol. Apr 14 2023;186:103996. 
doi:10.1016/j.critrevonc.2023.103996 
21. 
Strach MC, Prasanna T, Kirova YM, et al. Optimise not compromise: The importance of a 
multidisciplinary breast cancer patient pathway in the era of oncoplastic and reconstructive surgery. Crit Rev 
Oncol Hematol. Feb 2019;134:10-21. doi:10.1016/j.critrevonc.2018.11.007 
22. 
NCRI. Living with and Beyond cancer: Research priortities. https://www.ncri.org.uk/groups/living-with-
beyond-cancer-group/research-priorities/ 
23. 
Equity and excellence: Liberating the NHS. White Paper (2010). 
24. 
Black N. Patient reported outcome measures could help transform healthcare. BMJ. Jan 2013;346:f167. 
doi:10.1136/bmj.f167 
25. 
Chen CM, Cano SJ, Klassen AF, et al. Measuring quality of life in oncologic breast surgery: a systematic 
review of patient-reported outcome measures. Breast J. 2010 Nov-Dec 2010;16(6):587-97. doi:10.1111/j.1524-
4741.2010.00983.x 
26. 
Cohen WA, Mundy LR, Ballard TN, et al. The BREAST-Q in surgical research: A review of the literature 
2009-2015. J Plast Reconstr Aesthet Surg. Feb 2016;69(2):149-62. doi:10.1016/j.bjps.2015.11.013 
27. 
Liu LQ, Branford OA, Mehigan S. BREAST-Q Measurement of the Patient Perspective in Oncoplastic 
Breast Surgery: A Systematic Review. Plast Reconstr Surg Glob Open. Aug 2018;6(8):e1904. 
doi:10.1097/GOX.0000000000001904 
28. 
Agrawal A, Mirshekar-Syahkal B. Use of combination of modules of BREAST-Q in partial breast 
reconstruction 
with 
lateral 
chest 
wall 
perforator 
flap. 
Eur 
J 
Surg 
Oncol. 
2016;42(5):S39. 
doi:https://doi.org/10.1016/j.ejso.2016.02.155 
29. 
Ang Z, Tenovici A, Roy P, Agrawal A. Use of a combination of modules of BREAST-Q in lateral chest wall 
flap partial breast reconstruction: a tale of two cities. Breast Cancer Res Treat. 2018;167(UK Interdisciplinary 
Breast Cancer Symposium. P6.16):309-405. doi:https://doi.org/10.1007/s10549-017-4585-x 
30. 
Ang Z, Tenovici A, Roy P, Agrawal A. Use of a combination of modules of BREAST-Qin lateral chest wall 
flap partial breast reconstruction: a tale of two cities. Breast Cancer Res Treat. 2018;(UK Interdisciplinary Breast 
Cancer Symposium. P6.16)doi:https://doi.org/10.1007/s10549-017-4585-x 
31. 
Gilmour A, Cutress R, Gandhi A, et al. Oncoplastic breast surgery: A guide to good practice. Eur J Surg 
Oncol. Sep 2021;47(9):2272-2285. doi:10.1016/j.ejso.2021.05.006 
32. 
Hamdi M, Van Landuyt K, Hijjawi JB, Roche N, Blondeel P, Monstrey S. Surgical technique in pedicled 
thoracodorsal artery perforator flaps: a clinical experience with 99 patients. Plast Reconstr Surg. May 
2008;121(5):1632-41. doi:10.1097/PRS.0b013e31816c3bfa 
33. 
Tashiro K, Harima M, Mito D, et al. Preoperative color Doppler ultrasound assessment of the lateral 
thoracic artery perforator flap and its branching pattern. J Plast Reconstr Aesthet Surg. Jun 2015;68(6):e120-5. 
doi:10.1016/j.bjps.2015.02.011 
34. 
ABS AoBS. ABS Consensus Margin Width in Breast Conservation Surgery. 2015. 2015. 
35. 
de Blacam C, Ogunleye AA, Momoh AO, et al. High body mass index and smoking predict morbidity in 
breast cancer surgery: a multivariate analysis of 26,988 patients from the national surgical quality improvement 
program database. Ann Surg. Mar 2012;255(3):551-5. doi:10.1097/SLA.0b013e318246c294 
36. 
von Elm E, Altman DG, Egger M, et al. The Strengthening the Reporting of Observational Studies in 
Epidemiology (STROBE) statement: guidelines for reporting observational studies. Lancet. Oct 20 
2007;370(9596):1453-7. doi:10.1016/S0140-6736(07)61602-X 
 
 
 

PartBreCon-Pro study_Protocol_v.4.1 
 
15 
Table 1: PartBreCon-Pro Study Dataset 
Item 
Definition 
Centre 
Name of unit (in 3 letters abbreviation)  
e.g., Royal Breast Hosp-RBH 
Study ID 
ID from the given unit -starting 001 
Date of birth 
Age in years 
Date of diagnosis 
month / year 
Date of surgery 
month / year 
Presentation 
symptomatic / screener / family history / other 
Breast size  
Bra size (Band and Cup e.g., 28C) 
BMI 
  
Significant co-morbidities  
free text 
Smoking within 3 months 
y/n 
Largest Tumour size on any 
imaging (mm) at diagnosis (cT) 
largest tumour diameter on any  
imaging [mm] 
Largest post-NACT tumour size 
(ycT) 
largest diameter on any imaging [mm] after  
neo-adj chemo / hormonal Rx 
Position of tumour(s) in breast 
UOQ, LOQ, UIQ, LIQ, central 
If Multifocal, Largest resected 
tumour plus distance between foci 
(EXTENT) 
If multifocal, largest distance between foci  
on any imaging [mm] 
Axillary USS lymph node status 
abnormal / normal / not applicable  
If abnormal USS nodes (n) 
n = number of nodes abnormal 
If Axillary core biopsy / FNA  
(cN+ or cN0) 
metastasis (cN+) / normal (cN0)/ not applicable 
If cN+, Post-NACT nodal status 
(ycN) 
 
Joint operation with plastic 
surgeon 
y/n 
Type of Flap 
LICAP, LTAP, AICAP, MICAP, etc. Combined 
Stage - single vs two-stages 
(delayed, if any) 
  
Placement (propeller or flip) 
Propeller or flip 
Specimen weight [gram] 
  
Contralateral symmetrisation 
y/n 
Axillary surgery, type 
none / SNB / Sampling/ TAD/ ANC / ANC following SNB  
Drain (days) 
days (zero if none) 
Length of hospital stay [days] 
days (zero if day case; 1 if 23 hours stay; and so on) 

PartBreCon-Pro study_Protocol_v.4.1 
 
16 
Post operative complication 
(Clavien-Dindo) 
y/n 
Major / minor 
major = required readmission or reoperation  
Infection 
y/n 
Any positive microbiology 
y/n; if yes, growth 
Antibiotics 
IV/Oral, which 
Haematoma/Seroma 
y/n 
Fat necrosis 
y/n 
Delayed wound healing 
y/n 
Flap loss - full, partial or none 
full, partial or none 
Unplanned readmission to 
hospital within 30 days 
y/n 
Unplanned return to theatre 
within 30 days 
y/n 
Additional optimising procedures 
(in m/delayed) 
free text 
Tumour Type 
DCIS, ductal, lobular, etc.  
Whole tumour size [mm] 
  
Invasive Tumour size [mm] 
  
pT 
  
ypT 
  
Grade  
1/2/3 if invasive, no need to indicate if DCIS 
ER 
pos / neg 
PR  
pos / neg 
HER-2 
pos / neg 
Multifocal  
y/n 
Closest margin distance (mm) 
  
Margins, clear or not (MDT) 
involved / clear 
Number of re-excisions for 
involved margins 
  
pN 
  
ypN 
  
  
  
Neo-adjuvant chemo incl. anti-
HER-2 treatment 
anti-HER2 regime 
Neo-adjuvant immunotherapy 
y/n 
Neo-adjuvant hormonal therapy ≥ 
3 months 
y/n 
Neo-adjuvant radiotherapy if any 
free text 
Gene array testing score if 
performed 
Oncotype DX, Prosigna, others 
Adjuvant chemotherapy 
y/n 

PartBreCon-Pro study_Protocol_v.4.1 
 
17 
Adjuvant anti-HER2 
y/n 
Adjuvant endocrine therapy 
y/n 
Adjuvant CDK4/6 inhibitors 
y/n 
Adjuvant bisphosphonates 
 
Adjuvant radiotherapy 
y/n 
Adjuvant radiotherapy dose 
  
Adjuvant radiotherapy fractions 
  
Adjuvant radiotherapy fields 
included 
2 / 3 / 4 field 
Boost RT  
y/n 
Boost dose 
  
Boost fractions 
  
Boost method 
integrated / IMRT 
Boost volume - GTV 
As determined by Oncologist – GTV (Gross Tumour Volume) 
Boost volume - CTV 
As determined by Oncologist - CTV (Clinical Tumour Volume) 
Boost volume - PTV 
As determined by Oncologist – PTV (Planning Tumour Volume) 
Boost volume - Surgical 
Optional (as by Surgeon, include 5mm tissue around flap) 
Date of last follow-up 
(clinical/mammogram) 
month / year 
Recall Biopsies 
y/n 
Local Recurrence  
y/n 
Regional recurrence 
y/n 
Distal recurrence 
y/n 
Date of recurrence 
month / year 
Death 
y/n 
Death breast cancer related 
y/n 
Death NOT breast cancer related 
y/n 
 
 
 
End of the Document