MIAMI - Safe Surgery for multiple breast cancers
Research type
Research Study
Full title
Can patients with multiple breast cancers in the same breast avoid mastectomy by having multiple lumpectomies to achieve equivalent rates of local breast cancer recurrence? A randomised controlled feasibility study.
IRAS ID
228164
Contact name
Zoe Winters
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2017/10/20 , data protection registration number
Duration of Study in the UK
2 years, 9 months, 31 days
Research summary
Sometimes women have more than one breast cancer in the same breast at the same time. These women are usually offered a mastectomy (removal of that breast) and breast reconstruction. It may be possible to treat these patients by removing each cancer using breast-saving surgery (lumpectomies), used for women with only one breast cancer. Databases show that women who had lumpectomies did well, but they may have been healthier before the surgery than those who had a mastectomy. We need to be sure that lumpectomy is effective, safe, and acceptable for this patient group before making it universally available.
We will run a small study to evaluate whether a sufficient number of eligible patients can be identified and are willing to accept randomisation of the interventions in question. Recruitment and compliance rates of which will inform the feasibility and design of a larger trial.
This will comprise a multi-centre randomised controlled trial in women with Multiple Ipsilateral Breast cancer (MIBC) requiring surgery. Participants will receive either Therapeutic Mammoplasty (TM) following excision of each cancer focus or mastectomy (+/- reconstruction). Patients will be randomised (1:1) into either intervention or control group. Therapeutic mammoplasty is an operation to remove breast cancer(s) whilst also significantly reducing the size of the breast. Therapeutic mammoplasty can be used to remove more than one cancer in the breast using separate lumpectomies. Both skin and breast tissue are removed, leaving scars similar to those seen after a standard breast reduction.
Each patient is followed up for 12 months post treatment with a total of 50 patients recruited. Timings of the follow-up visits are aligned with standard of care practice for this patient population with quality of life questionnaires and clinical photographs completed before and after surgery.
Twenty women will also be invited to an optional semi-structured interview at twelve months.
REC name
London - City & East Research Ethics Committee
REC reference
18/LO/0133
Date of REC Opinion
14 Mar 2018
REC opinion
Further Information Favourable Opinion