PARTial BREast RECONstruction With Chest Wall Perforator Flap (PartBreCon)

December 7, 2024 updated by: Amit Agrawal, Cambridge University Hospitals NHS Foundation Trust

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.

Study Overview

Status

Recruiting

Conditions

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

Study Type

Observational

Enrollment (Estimated)

1001

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
        • Recruiting
        • Cambridge University Hospitals NHS Trust
        • Principal Investigator:
          • Amit Agrawal
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Complications
Time Frame: Within 30 days of surgery

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

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.
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.

Outcomes:

• Frequency and reasons for additional surgical procedures.

Measures:

• Revision rates by indication (e.g., aesthetic concerns, complication management).
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

Outcomes:

• Recurrence rates (local, regional, distant).

Measures:

• Time to recurrence (mean/median in months).
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

Outcomes:

• Survival rates

Measures:

• Disease-free survival (DFS) and overall survival (OS) (mean/median in months).
From enrolment until the date of death, or the end of study, whichever came first, assessed up to 36 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient-reported outcomes: Patient satisfaction and quality of life
Time Frame: Pre-operative, Post-operative and Post-radiotherapy (6 months).

Outcomes:

• Patient satisfaction and quality of life (QoL).

Measures:

• Measurement using a validated instrument, BREAST-Q, which converts the individual patient response items into a BREAST-Q score ranging from 0-100; a higher score means greater satisfaction of better QoL
Pre-operative, Post-operative and Post-radiotherapy (6 months).
Patient-reported outcomes: Upper extremity dysfunction
Time Frame: Pre-operative, Post-operative and Post-radiotherapy (6 months).

Outcomes:

• Disability of the Arm, Shoulder and Hand

Measures:

• Measurement using a validated instrument, QuickDASH (an abbreviated version of the Disability of the Arm, Shoulder, and Hand), which converts the individual patient response items into a QuickDASH score ranging from 0 to 100; a higher score means a greater level of disability and severity.
Pre-operative, Post-operative and Post-radiotherapy (6 months).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Collaborators

Oxford University Hospital

Investigators

  • Principal Investigator: Amit Agrawal, Cambridge University Hospitals NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

November 26, 2024

First Submitted That Met QC Criteria

December 7, 2024

First Posted (Estimated)

December 11, 2024

Study Record Updates

Last Update Posted (Estimated)

December 11, 2024

Last Update Submitted That Met QC Criteria

December 7, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID5342

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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