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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
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
Are there results?
Not yet: the study is under way

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.

Amit Agrawal, DM, FRCS contact

+44 1223 216315

amit.agrawal2@nhs.net

United Kingdom1 site, 1 recruiting

  • Cambridge University Hospitals NHS Trust

    Cambridge, Cambridgeshire, CB2 0QQ

    Amit Agrawal, DM, FRCSsurg, +44 1223 216 315, amit.agrawal2@nhs.net

    Amit Agrawal

    Recruiting

Other trials in United Kingdom

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:

  1. Patient Demographics and Tumour characteristics
  2. Patient demographics: age, body mass index (BMI), comorbidities
  3. Preoperative tumour characteristics and location influencing surgical planning
  4. Treatment characteristics
  5. Surgical: operative data, including flap types and distribution
  6. Oncological: systemic therapies (adjuvant and neoadjuvant), radiotherapy
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.

  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).

    Measured: Within 30 days of surgery

Secondary outcomes (4)

  1. 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.

  2. 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.

  3. 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

  4. 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.

  1. First posted11 Dec 2024
  2. Study start1 Jun 2023
  3. Primary completion31 May 2026 (estimated)
  4. Study completion31 May 2026 (estimated)

Resources

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
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 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 15308400

  • 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.

    PubMed 28861373

  • 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.

    PubMed 29980320

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amit Agrawal, DM, FRCS (+44 1223 216315, amit.agrawal2@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Surgical Complications (time frame: Within 30 days of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06728527, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.

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