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NCT Number: NCT06728527

PARTial BREast RECONstruction With Chest Wall Perforator Flap

The goal of this observational study is to ascertain the outcomes following partial breast reconstruction using chest wall perforator flaps after breast conservation surgery.

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Key information

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3) Breast Carcinoma Breast Diseases Breast Neoplasms Breast Reconstruction Surgery Breast Surgery Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Cambridge University Hospitals NHS Trust

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location status: Recruiting

Location contact

Amit Agrawal

PRINCIPAL_INVESTIGATOR

Amit Agrawal, DM, FRCSsurg

CONTACT

[email protected]

+44 1223 216 315

About this study

The Main Outcomes and Measures are:

A) Patient Demographics and Tumour characteristics

  • Patient demographics: age, body mass index (BMI), comorbidities
  • Preoperative tumour characteristics and location influencing surgical planning

B) Treatment characteristics

  • Surgical: operative data, including flap types and distribution
  • Oncological: systemic therapies (adjuvant and neoadjuvant), radiotherapy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

  2. 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).

  3. 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).

  4. 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).

Other outcomes

  1. 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

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amit Agrawal, DM, FRCS

CONTACT

[email protected]

+44 1223 216315

Sponsors and collaborators

Lead sponsor

Cambridge University Hospitals NHS Foundation Trust

Other

Collaborators

  • Oxford University Hospitals NHS Trust

Registry information

Official study title

PartBreCon-Pro Study: PARTial BREast RECONstruction With Chest Wall Perforator Flap, a PROspective Study of Clinical and Patient Reported Outcomes

Acronym: PartBreCon

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 11, 2024
Registry last updated
Dec 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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