Neo-RT
Research type
Research Study
Full title
Pre-operative breast intensity modulated radiotherapy in patients receiving neo-adjuvant hormonal treatment for breast cancer - a feasibility study.
IRAS ID
208900
Contact name
Charlotte Coles
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust & University of Cambridge
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Need for project
Four in 10 women diagnosed with breast cancer undergo mastectomy with or without breast reconstruction and less than half are satisfied with how they look unclothed. Breast conservation (removing the area with the lump only) can offer less extensive surgery and improved breast appearance, which can therefore increase well-being.Intensity-modulated radiotherapy (IMRT) closely shapes the radiation beam to the cancer and is currently given after breast surgery. A new combination of IMRT followed by hormone treatment given before surgery, may increase the possibility of breast conservation.
Aims of project
To test whether it is feasible to deliver IMRT and hormonal treatment before surgery in patients where initial breast conservation may not be possible. It will also explore if:
1. The number of mastectomies can be reduced
2. New biological/imaging markers of response to treatment can be developed
3. Whether radiotherapy affects the immune system
The direct effect of radiotherapy on breast cancer and new markers of response are important research gaps.Testing of the project
43 patients will have 3 weeks of IMRT, followed by 20 weeks of hormonal therapy before surgery. Blood tests and tumour biopsies paired with scans will be carried out before, during and after radiotherapy.Patient benefit
The choice of breast conservation surgery for more women is an important goal and could give a better survivorship experience (an important research gap). The results may help design larger trials of pre-surgery IMRT, possibly with new drugs/immune therapies that could improve survival.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
17/EE/0176
Date of REC Opinion
29 Jun 2017
REC opinion
Further Information Favourable Opinion