PARTial BREast RECONstruction With Chest Wall Perforator Flap

NCT06728527 | Recruiting

• 1 other identifier: ID5342
• Study Type: observational
• Target: 1,001
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

breast oncoplastic, recon, chest wall perforator flap, PROMS

Outcome Measures

Primary Outcomes (1)

• Surgical Complications

  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).

  Within 30 days of surgery

Secondary Outcomes (4)

• Oncological Clearance

  From enrolment until the date of re-operation within 12 months of first surgery, or the end of study, whichever came first.

• Revisional surgery

  From enrolment until the date of revision within 36 months of surgery, or the end of study, whichever came first.

• Oncological: Recurrence

  From enrolment until the date of recurrence, or the end of study, whichever came first, assessed up to 36 months

• Oncological: Survival

  From enrolment until the date of death, or the end of study, whichever came first, assessed up to 36 months

Other Outcomes (2)

• Patient-reported outcomes: Patient satisfaction and quality of life

  Pre-operative, Post-operative and Post-radiotherapy (6 months).

• Patient-reported outcomes: Upper extremity dysfunction

  Pre-operative, Post-operative and Post-radiotherapy (6 months).

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female breast cancers
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Women over the age of 18 years who would have been offered all options (simple wide local excision, therapeutic mammaplasty, mastectomy with or without immediate whole breast reconstruction)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead
• Oxford University Hospitals NHS Trust: collaborator

Study Sites (1)

Cambridge University Hospitals NHS Trust

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

RECRUITING

Related Publications (10)

• 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 perforator flaps. Breast. 2023 Oct;71:82-88. doi: 10.1016/j.breast.2023.07.007. Epub 2023 Jul 17.

  PMID: 37544090 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Association of Breast Surgery A. NHSBSP and ABS Audit. Accessed 24.05.2020, https://associationofbreastsurgery.org.uk/professionals/audit/nhs-breast-screening-programme-audit/

  BACKGROUND

• 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 BACKGROUND

• 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

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Roy PG, Tenovici AA. Staged approach to partial breast reconstruction to avoid mastectomy in women with breast cancer. Gland Surg. 2017 Aug;6(4):336-342. doi: 10.21037/gs.2017.03.08.

  PMID: 28861373 BACKGROUND

• Brouwers PJAM, van Werkhoven E, Bartelink H, Fourquet A, Lemanski C, van Loon J, Maduro JH, Russell NS, Scheijmans LJEE, Schinagl DAX, Westenberg AH, Poortmans P, Boersma LJ; Young Boost Trial research group. 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. 2018 Sep;128(3):434-441. doi: 10.1016/j.radonc.2018.06.020. Epub 2018 Jul 3.

  PMID: 29980320 BACKGROUND

Related Links

• Lead Site

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Amit Agrawal

  Cambridge University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amit Agrawal, DM, FRCS

CONTACT

+44 1223 216315; amit.agrawal2@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Oncoplastic Breast Surgeon

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 11, 2024
• Study Start: June 1, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

GB (1)