The ANTHEM Feasibility Study

• Research type

  Research Study

• Full title

  The ANTHEM Feasibility Study : Is A Novel THErapeutic mammaplasty procedure a safe and effective surgical alternative to Mastectomy for treatment of breast cancer?

• IRAS ID

  281086

• Contact name

  Shelley Potter

• Contact email

  shelley.potter@bristol.ac.uk

• Sponsor organisation

  University Of Bristol

• Duration of Study in the UK

  2 years, 4 months, 1 days

• Research summary

  Breast conserving surgery (BCS) is the preferred treatment for many women with breast cancer. Standard techniques, however frequently result in poor cosmetic outcomes and mastectomy (removal of the breast) with or without immediate breast reconstruction is often recommended. Currently 40% of the 55,000 women diagnosed with breast cancer each year undergo a mastectomy but of these only 1 in 4 receive reconstruction.

  Oncoplastic breast conservation surgery (OPBCS) describes a range of volume replacement (e.g local perforator flap LPF)) and volume displacement techniques (e.g Therapeutic mammaplasty (TM)) that may extend the boundaries of standard BCS and allow some women to avoid mastectomy and potentially improve their quality of life.
  
  There is a need for high-quality research to determine whether OPBCS offers a safe and effective alternative to mastectomy but preliminary work is needed to ensure a future large-scale study is feasible, well-designed and addresses questions important to patients and the NHS.
  
  The feasibility study will have 4 parts
  1. A national survey (a nested service evaluation) to understand current national practice of OPBCS
  2. A pilot study to explore how many women are suitable for OPBCS as an alternative to mastectomy; choose to undergo the procedure and whether existing patient-reported outcome questionnaires measure outcomes important to patients undergoing different types of surgery accurately and can reliably be used in a future large study.
  3. Interviews with patients to explore their views of different surgical options and the adequacy of questionnaires used to assess key patient-reported outcomes
  4. Design of the future study

  This study will be the first-step providing high-quality evidence to support the use of OPBCS as an alternative to mastectomy. It will promote choice, improving outcomes for patients, many of whom will be long-term breast cancer survivors.

• REC name

  Wales REC 6

• REC reference

  20/WA/0225

• Date of REC Opinion

  21 Aug 2020

• REC opinion

  Favourable Opinion