Clinical trial NCT06728527: PARTial BREast RECONstruction With Chest Wall Perforator Flap
Official title: PartBreCon-Pro Study: PARTial BREast RECONstruction With Chest Wall Perforator Flap, a PROspective Study of Clinical and Patient Reported Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Oxford University Hospitals NHS Trust
First posted: 2024-12-11
Enrollment: 1001
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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

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

Primary outcomes:
measure: Surgical Complications
timeFrame: Within 30 days of surgery
Secondary outcomes:
measure: Oncological Clearance
timeFrame: From enrolment until the date of re-operation within 12 months of first surgery, or the end of study, whichever came first.
measure: Revisional surgery
timeFrame: From enrolment until the date of revision within 36 months of surgery, or the end of study, whichever came first.
measure: Oncological: Recurrence
timeFrame: From enrolment until the date of recurrence, or the end of study, whichever came first, assessed up to 36 months
measure: Oncological: Survival
timeFrame: From enrolment until the date of death, or the end of study, whichever came first, assessed up to 36 months
Other outcomes:
measure: Patient-reported outcomes: Patient satisfaction and quality of life
timeFrame: Pre-operative, Post-operative and Post-radiotherapy (6 months).
measure: Patient-reported outcomes: Upper extremity dysfunction
timeFrame: Pre-operative, Post-operative and Post-radiotherapy (6 months).
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Trust
state: Cambridgeshire
Study officials:
affiliation: Cambridge University Hospitals NHS Trust
name: Amit Agrawal
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Association of Breast Surgery A. NHSBSP and ABS Audit. Accessed 24.05.2020, https://associationofbreastsurgery.org.uk/professionals/audit/nhs-breast-screening-programme-audit/
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.