PARTial BREast RECONstruction With Chest Wall Perforator Flap

Recruiting

• Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3); Breast Carcinoma; Breast Neoplasms; Breast Surgery; Breast Reconstruction Surgery

• Registration Number: NCT06728527
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

The goal of this observational study is to ascertain the outcomes following partial breast reconstruction using chest wall perforator flaps after breast conservation surgery.

Detailed Description

The Main Outcomes and Measures are:

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

Study Timeline

• Study Start: 2023-06-01
• Study First Submitted: 2024-11-26
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-07
• Last Update Submitted: 2024-12-07
• Study First Posted: 2024-12-11
• Last Update Posted: 2024-12-11
• Primary Completion: 2026-05-31
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1001

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Surgical Complications	Within 30 days of surgery	Outcomes: • Rates of complications (e.g., Haematoma, Seroma, Infection, Delayed Wound healing, Fat necrosis, Flap loss, etc).; Measures: • Complication rates stratified by severity (e.g., Clavien-Dindo classification).

Secondary Outcome Measures

Name	Time	Method
Oncological Clearance	From enrolment until the date of re-operation within 12 months of first surgery, or the end of study, whichever came first.	Outcomes: • Effectiveness of surgery in achieving oncological goals.; Measures: • Re-operation rates: Proportion of patients requiring further surgery (re-excisions and/or mastectomy) to achieve Oncological clearance.
Revisional surgery	From enrolment until the date of revision within 36 months of surgery, or the end of study, whichever came first.	Outcomes: • Frequency and reasons for additional surgical procedures.; Measures: • Revision rates by indication (e.g., aesthetic concerns, complication management).
Oncological: Recurrence	From enrolment until the date of recurrence, or the end of study, whichever came first, assessed up to 36 months	Outcomes: • Recurrence rates (local, regional, distant).; Measures: • Time to recurrence (mean/median in months).
Oncological: Survival	From enrolment until the date of death, or the end of study, whichever came first, assessed up to 36 months	Outcomes: • Survival rates; Measures: • Disease-free survival (DFS) and overall survival (OS) (mean/median in months).

Trial Locations

Locations (1)

Cambridge University Hospitals NHS Trust; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom