PartBreCon-Pro Study

Overview

This is a non-interventional, observational, international, multicentre, prospective cohort study of partial breast reconstruction with a chest wall perforator flap (CWPF) following breast conservation surgery. It is registered at the Cambridge University Hospitals and fully approved for prospective multi-centre data-sharing (incoming) into the RedCap^TM database (V13.8.1), which is supported and managed by the Cambridge Clinical Trials Unit.

Objectives

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 seeks to establish a performance standard for the CWPF procedure based on robust, reliable, and valid data.

Therefore, a prospective and representative dataset is needed to extract reliable and valid statistical distributions that show:

Part A: Surgical treatment dataset

Besides patient demographics, tumour, and surgical characteristics, it will include surgical outcomes variables, including the determination of 

• Complications rate and types (within 30 days in line with NHS Health Episode Statistics)
• Re-operation rates (within 12 months)
• Revisional surgery (during the study period)

Part B: Oncological treatment dataset

All centres are encouraged to collaborate with their Oncology colleagues in a multidisciplinary manner to gather oncological treatment records.

• Radiotherapy data to study current practice
• Recurrence rates
• Survival rates

Part C: PROMS 

PROMS will be administered pre-operatively and 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.

Centres utilising PROMS are requested to complete this component as well. Additionally, centres giving PROMS post-operatively but pre-radiotherapy can continue to do so. Once patients submit the PROMS scores, they must be entered into the RedCap database. However, centres not using PROMS in their routine practice cannot audit this component. 

Inclusion/ exclusion criteria

Inclusion criteria:

• Patients undergoing partial breast reconstruction using CWPF for primary breast cancer 
• Delayed correction of breast deformity after previous BCS
• Each surgeon is to have performed a minimum of 10 CWPF
• Each centre anticipates completing a minimum of 10/year

Exclusion criteria: 

• Patients undergoing volume displacement BCS
• Patients undergoing mastectomy +/- immediate breast reconstruction

Planned sample size

It is a multicentre international cohort study open to recruitment from any number of centres within the UK ABS membership and beyond, provided that participating surgeons in those centres have performed 10 CWPF cases to demonstrate experience beyond the early learning phase, which could influence surgical outcomes. Each centre anticipates that approximately 10 CWPF surgeries will be conducted each year.

Total number of sites planned

Based on the above, there are no limits on how many centres can join, provided they confirm the above criteria, gain approval, and register the study locally with their Audit (or Patient Outcomes) team. It is known that many centres globally would need Ethics approval (ClinicalTrials.gov Identifier: NCT06728527).

Timeline

The study is approved until June 2026; however, due to a recent increase in interest, an extension will likely be needed to allow both new and existing centres to complete their datasets, including follow-up.