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UCL Division of Surgery and Interventional Science

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MIAMI Trial Information

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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

Current breast imaging methods mean that multiple breast cancers are being diagnosed in many women who are usually offered mastectomy to remove their whole breast with immediate or delayed breast reconstruction. However, these multiple smaller cancers may be treated using breast-saving surgery, called breast-conserving surgery, which is likely to occur currently in about a quarter of women. This breast-saving surgery aims to remove each cancer and to remodel the breast tissue, called a therapeutic mammoplasty. Therapeutic mammoplasty can be used to remove more than one cancer in the breast. Both skin and breast tissue are removed, leaving scars similar to those seen after a standard breast reduction. The MIAMI Trial aims to find out if breast-saving surgery is as safe as mastectomy in terms of controlling the rates of a cancer returning in the same breast or armpit, or elsewhere in the body.

Currently, surgeons are unsure about the quality of the studies about the long-term safety of breast-saving surgery. However, some studies suggest that breast-saving surgery may be as safe as mastectomy, but there may be a slightly increased 5 and 10-year risk (around 2%) of the cancer returning in the remaining breast tissue. The potential safety of breast-saving surgery also depends on additional treatments of the breast tissue using radiotherapy and chemotherapy and/or endocrine treatments as well as bone strengthening drugs. All of these treatments can work together to kill possible microscopic cancer cells in the breast and reduce the chances of any cancer recurring in the breast. The study will also record women’s quality of life, satisfaction with the appearance of their breasts and the costs of the surgery types.

The sponsor of the MIAMI Trial is University College London and the trial is funded by the NIHR Research for Patient Benefit.

ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT03514654

ISRCTN: http://www.isrctn.com/ISRCTN17987569