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Recruiting NCT06728527

PARTial BREast RECONstruction With Chest Wall Perforator Flap

— Observational Breast Cancer Early Stage Breast Cancer (Stage 1-3) Breast Carcinoma Breast Neoplasms Breast Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Carcinoma, Breast Neoplasms, Breast Surgery. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

PartBreCon-Pro Study: PARTial BREast RECONstruction With Chest Wall Perforator Flap, a PROspective Study of Clinical and Patient Reported Outcomes

Overview

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

Primary outcome measures

  • Surgical Complications [Time frame: Within 30 days of surgery]
Secondary outcome measures (4)
  • Oncological Clearance [Time frame: From enrolment until the date of re-operation within 12 months of first surgery, or the end of study, whichever came first.]
  • Revisional surgery [Time frame: From enrolment until the date of revision within 36 months of surgery, or the end of study, whichever came first.]
  • Oncological: Recurrence [Time frame: From enrolment until the date of recurrence, or the end of study, whichever came first, assessed up to 36 months]
  • Oncological: Survival [Time frame: From enrolment until the date of death, or the end of study, whichever came first, assessed up to 36 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United Kingdom · 1 center
  • Cambridge University Hospitals NHS Trust — Cambridge

Publications

  • Agrawal A, Romics L, Thekkinkattil D, Soliman M, Kaushik M, Barmpounakis P, Mortimer C, Courtney CA, Goyal A, Garreffa E, Carmichael A, Lane RA, Rutherford C, Kim B, Achuthan R, Pitsinis V, Goh S, Ray B, Grover K, Vidya R, Murphy J; PartBreCon Collaborators. 'PartBreCon' study. A UK multicentre retrospective cohort study to assess outcomes following PARTial BREast reCONstruction with chest wall pe PMID 37544090
  • 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. 2023 Jun;186:103996. doi: 10.1016/j.critrevonc.2023.103996. Epub 2023 Apr 14. PMID 37061072
  • Agrawal A. Oncoplastic breast surgery and radiotherapy-Adverse aesthetic outcomes, proposed classification of aesthetic components, and causality attribution. Breast J. 2019 Mar;25(2):207-218. doi: 10.1111/tbj.13193. Epub 2019 Feb 1. PMID 30710399
  • Association of Breast Surgery A. NHSBSP and ABS Audit. Accessed 24.05.2020, https://associationofbreastsurgery.org.uk/professionals/audit/nhs-breast-screening-programme-audit/
  • 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. 2020 Aug;20(4):e510-e515. doi: 10.1016/j.clbc.2020.03.003. Epub 2020 Mar 20. PMID 32284305
  • 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
  • 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. 2007 Jan;31(1):46-50. doi: 10.1007/s00268-006-0396-7. PMID 17180559
  • Hamdi M, Van Landuyt K, Monstrey S, Blondeel P. Pedicled perforator flaps in breast reconstruction: a new concept. Br J Plast Surg. 2004 Sep;57(6):531-9. doi: 10.1016/j.bjps.2004.04.015. PMID 15308400

Identifiers

NCT: NCT06728527 · ID5342

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗