Breast Cancer Early Stage Breast Cancer (Stage 1-3)PartBreConNCT06728527
PARTial BREast RECONstruction With Chest Wall Perforator Flap
An observational study of Breast Cancer Early Stage Breast Cancer (Stage 1-3) and Breast Carcinoma, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Carcinoma, Breast Neoplasms
- How many people
- 1,001 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2023to 31 May 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- Patients undergoing volume displacement BCS
- Patients undergoing mastectomy +/- immediate breast reconstruction
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Cambridge University Hospitals NHS Trust
Cambridge, Cambridgeshire, CB2 0QQ
Amit Agrawal, DM, FRCSsurg, +44 1223 216 315, amit.agrawal2@nhs.net
Amit Agrawal
About this study
Official title: PartBreCon-Pro Study: PARTial BREast RECONstruction With Chest Wall Perforator Flap, a PROspective Study of Clinical and Patient Reported Outcomes
The goal of this observational study is to ascertain the outcomes following partial breast reconstruction using chest wall perforator flaps after breast conservation surgery.
Read the detailed description
The Main Outcomes and Measures are:
- Patient Demographics and Tumour characteristics
- Patient demographics: age, body mass index (BMI), comorbidities
- Preoperative tumour characteristics and location influencing surgical planning
- Treatment characteristics
- Surgical: operative data, including flap types and distribution
- Oncological: systemic therapies (adjuvant and neoadjuvant), radiotherapy
- 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
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within 30 days of surgery
Secondary outcomes (4)
Oncological Clearance
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.
Measured: From enrolment until the date of re-operation within 12 months of first surgery, or the end of study, whichever came first.
Revisional surgery
Outcomes:
- Frequency and reasons for additional surgical procedures.
Measures:
- Revision rates by indication (e.g., aesthetic concerns, complication management).
Measured: From enrolment until the date of revision within 36 months of surgery, or the end of study, whichever came first.
Oncological: Recurrence
Outcomes:
- Recurrence rates (local, regional, distant).
Measures:
- Time to recurrence (mean/median in months).
Measured: From enrolment until the date of recurrence, or the end of study, whichever came first, assessed up to 36 months
Oncological: Survival
Outcomes:
- Survival rates
Measures:
- Disease-free survival (DFS) and overall survival (OS) (mean/median in months).
Measured: From enrolment until the date of death, or the end of study, whichever came first, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start1 Jun 2023
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer Early Stage Breast Cancer (Stage 1-3)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,001 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Oxford University Hospitals NHS Trust
- Responsible party
- Principal investigator, Amit Agrawal, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Amit Agrawal, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06728527
- Sponsor's protocol ID
- ID5342
- Acronym
- PartBreCon
- Status last verified
- Dec 2024
- First submitted
- 26 Nov 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Since it is a large international observational study, any sharing will need approval from all though anonymised data might be shareable (to be decided later).
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 perforator flaps. Breast. 2023 Oct;71:82-88. doi: 10.1016/j.breast.2023.07.007. Epub 2023 Jul 17.
PubMed 37544090Garreffa 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.
PubMed 37061072Agrawal 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.
PubMed 30710399Association 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.
PubMed 32284305Agrawal 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.
PubMed 17180559Hamdi 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.
PubMed 15308400Roy 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.
PubMed 28861373Brouwers 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.
PubMed 29980320