iBRA2


UPDATE 21/11/2016

Rajiv Dave and Tim Rattay presented an update at the 3rd iBRA Study Day.

90 centres and 212 collaborators are contributing to the study. The target is to recruit 3000 patients. The study includes centres in Italy and Greece.

To date 713 patients have been recruited. It is vital for units to continue recruiting patients over the study time period. Well done to everyone who is taking part!


Background

Approximately 51,000 women each year will be diagnosed with breast cancer, and of these, up to 40% may require a mastectomy as the primary surgical treatment for their disease. The loss of breast can profoundly impact women’s quality of life and body image and, immediate breast reconstruction (IBR) is routinely offered in the UK to improve outcomes.

Complication rates following immediate breast reconstruction are important as they may lead to the delay or omission of important adjuvant cancer therapies such as chemo and/or radiotherapy. The clinical significance of short delays is unclear, but delays of between seven and 12 weeks have been shown to adversely impact on key oncological outcomes including recurrence free and overall survival. Furthermore, a recent meta-analysis suggests a 15% decrease in overall survival for every four week delay in the delivery of adjuvant chemotherapy.

Aims and objectives

The aim of iBRA-2 is to work with the Breast Reconstruction Research Collaborative network to evaluate the impact of immediate breast reconstruction (IBR) on the delivery of adjuvant therapy. It has the following objectives:

  1. To determine the proportion of patients undergoing mastectomy +/- IBR who experience a post-operative complication
  2. To determine the proportion of patients undergoing mastectomy +/- IBR who require adjuvant chemo and/or radiotherapy
  3. To determine the proportion patients undergoing mastectomy +/- IBR who experience a delay to or omission of their adjuvant therapy as a results of a surgical complication and predictors for adverse outcome (type of surgery, age, BMI, co-morbidities, smoking, neoadjuvant chemotherapy; bilateral surgery etc)
  4. To determine the time to adjuvant therapy (TTT) following mastectomy +/- IBR
  5. To generate high-quality data to inform decision-making for patients and health professionals
  6. To build on the network created by the iBRA study to include oncologists and build capacity for future research studies

International hospitals

iBRA2 welcomes collaboration with international breast and plastic surgery units. To date units in The Netherlands, Italy, Australia and USA are joining the study. If you would like to get involved, sign up below and contact ibra2study@gmail.com.

How do I get involved?

iBRA2 is now recruiting units. If you would like to be a collaborator, complete the form below and the team will get in touch. Joseph Ward and Marie Kearns are the RSTN Trainee Leads for the project.

The download section contains the project protocol and more detailed information.

The table at the bottom shows a live update of the units involved with the current collaborators.

Questions? Contact ibra2study@gmail.com.


  • Protocol development
  • NRES approval
  • Data collection
  • Data analysis
  • Manuscript submission
  • Publication
Professor Jane Blazeby
Professor of Surgery
Director of the MRC ConDuct II Hub and Bristol RCS Surgical Trials Centre
University of Bristol

Ms Nicola Barnes
Consultant Oncoplastic Breast Surgeon
University Hospitals South Manchester

Miss Beth Conroy
NIHR Doctoral Research Fellow
University of Liverpool
Liverpool CTRC

Mr Rajiv Dave
Specialist Registrar in Surgery
North West Deanery

Dr Adrian Harnett
Consultant Clinical Oncologist
Norfolk and Norwich Hospitals NHS Trust

Professor Chris Holcombe
Professor of Breast Surgery
Royal Liverpool and Broadgreen NHS University Trust

Miss Rachel O’Connell
Surgical Research Fellow
Royal Marsden NHS Foundation Trust

Miss Shelley Potter
Academic Clinical Lecturer in General Surgery
Centre for Surgical Research, University of Bristol

Mr Tim Rattay
NIHR Clinical Research Fellow
Department of Cancer Studies
University of Leicester

Dr Zoe Tolkien
Research Associate in Health Services Research
School of Social and Community Medicine
University of Bristol

Professor Paula Williamson
Professor of Medical Statistics
Liverpool CTRC

See table in main web page.
Bristol Surgical Trials Centre
Funding applied for from ABS.
ibra2study@gmail.com

RSTN Trainee Leads:
Joseph Ward
Marie Kearns