The PartBreCon-Pro Study

To build the first prospective, international, observational multicentre study of surgical, oncological and patient-reported outcomes following partial breast reconstruction with a chest wall perforator flap (CWPF) establishing a performance standard for the procedure. The study is registered at the Cambridge University Hospitals, fully approved for prospective multi-centre data maintenance in the RedCapTM database (V13.8.1), supported and managed by the Cambridge Clinical Trials Unit.

Seven or eight in every ten women with early breast cancer now have breast-conserving surgery (BCS)1. Although effective for small tumours, but a poor aesthetic result due to larger resections can leave patients with a distorted body image and lack of confidence. Furthermore, complications and addition of radiotherapy may worsen the cosmetic outcome2. Oncoplastic techniques are closing that gap, and chest wall perforator flaps, first use in breast described by Hamdi et al. in 20043, have become one of the more versatile options, replacing up to 50% of breast volume in small-to-medium breasts and, in the right patients, avoiding mastectomy altogether. Compared with the latissimus dorsi flaps, CWPFs have improved outcomes with no effect on harvest of back muscles, less post-operative pain and a faster recovery4.

A systematic review5 showed low complication rates. However, it included studies that had non-concordant datasets with variable follow-up. A large multi-centre series6 (15 UK centres, n = 507) by this BreCon collaborative 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 was retrospective, with no PROM data and inadequate data on radiotherapy, which can influence aesthetic outcomes and, consequently, PROMs.

It is widely acknowledged that radiotherapy materially affect the cosmetic result after breast conserving surgery, and most radiotherapy trials pre-date the newer oncoplastic techniques including CWPF reconstructive techniques². Some patients also need an extra "boost" dose to the tumour bed, and an early retrospective report found this planning genuinely complex in CWPF7, a gap a recent systematic review confirmed still exists for volume-replacement oncoplastic surgery generally8. A prospective surgical database therefore needs radiotherapy data to assess radiotherapy planning consistency with CWPFs and to understand its effect on cosmetic outcome.

Moreover, with most women now living well beyond their breast cancer diagnosis, how they feel about the result matters as much as the oncological outcome, and PROMs are increasingly central to how we assess surgical success9,10. BREAST-Q is a commonly used validated tool for PROMs11. Despite the lack of specific CWPF PROMS, combining its Breast-Conserving Therapy module with the back sub-scale of its Latissimus Dorsi module has shown promise in small pilots12,13, but without baseline data or proper demographic and treatment context, those findings are hard to interpret.

PartBreCon-Pro study is designed to address the above evidence gaps and establish outcomes standards commensurate with current and increasing ‘replacement’ procedure options that improve women's choices.

 Population: Women undergoing partial breast reconstruction with CWPF (LiCAP, LTAP, MiCAP, AiCAP and TDAP flaps) for primary breast cancer, or delayed correction of a breast deformity after previous BCS. Patients undergoing volume-displacement BCS, or mastectomy with or without immediate reconstruction, are excluded.

• Patient demographics, tumour and surgical characteristics

• Complications rate and types (within 30 days)

• Re-operation rates (within 12 months)

• Revisional surgery (during the study period)

• Radiotherapy data to study current practice

• Recurrence rates

• Survival rates

Pre-operatively and again six months after radiotherapy.

• Breast-Q’s BCT and LD flap back modules

• DASH (Disability of Arm, Shoulder and Hands) questionnaire will assess shoulder function.

 All data is entered by each centre into the central RedCap™ database (v13.8.1), hosted and IG-approved at Cambridge University Hospitals. In keeping with Caldicott principles, no identifiable patient data is submitted centrally, and each patient is automatically assigned a study ID within the database.

 Duration: 60 months (01 July 2023 – 30 June 2028)

CWPF is now an established part of the oncoplastic toolkit, but the evidence supporting it has never included prospective PROM or radiotherapy data at scale. PartBreCon-Pro is designed to fill that gap, building beyond the 2023 retrospective series⁶ to give CWPF surgery a prospective performance standard that reflects their clinical outcome. We plan to report findings through 3–4 peer-reviewed papers, national and international conferences, and patient and public engagement, including through Independent Cancer Patients' Voice and the NCRI consumer forum.