TUmour-volume to breast-volume RAtio for Improving COSmetic Results in Breast Cancer Patients (TURACOS); a randomised controlled trial.

Long-term survival, recurrence rates and cosmetic result are important endpoints after breast conserving surgery (BCS) in breast cancer patients. Previous studies show that breast conserving surgery followed by radiation therapy is as safe, considering long-term survival and local recurrence rates, as mastectomy in breast cancer patients. Preoperative tools to predict good cosmetic outcome are not yet well established. We proved that tumour location and tumour volume versus breast volume ratio are independent predictors of a good cosmetic result when opting for breast conserving surgery. A prediction model based on these independent predictors and the quality of life in breast cancer patients followed by either breast conserving surgery or mastectomy (with or without direct reconstruction) will be tested in this study. Patients will randomly be assigned to either the intervention or the control group. All participants will undergo a preoperative three-dimensional ultrasonography to assess tumour- and breast-volume. In the intervention group the tumour volume and breast volume will be used for the prediction model. In the control group the three-dimensional ultrasonography will be calculated after inclusion of all participants. Taken the results of the prediction model in account a final decision will be made between breast conserving surgery or mastectomy (followed by direct reconstruction), aiming for the best cosmetic result.
An expert panel will, based on medical photographs, assess cosmetic outcome after BCS, primary outcome of the study. Secondary outcomes Quality of Life and psychosocial functioning will be measured with the EORTC and BREAST-Q questionnaire respectively. Other secondary outcome parameters concern pathological results, cost-effectiveness, radiation effects and cosmetic outcome as assessed by the BCCT.core software program. Patients’ last follow up within the study will be 3 years after initial surgery. In summary, this study aims to improve cosmetic outcome following BCS in breast cancer patients by using a preoperative prediction model. By improving cosmetic outcome following BCS it is targeted to increase quality of life and psychosocial functioning in breast cancer patients.

Preoperative use of a prediction model in breast cancer patients, concerning tumour volume versus breast volume ratio and tumour localisation, improves cosmetic results in breast conserving surgery

Inclusion

Randomisation

Follow up T0 - prior to surgery

Follow up T1 - 2 weeks after initial surgery

Follow up T2 - 3 months after initial surgery

Follow up T3 - 1 year after initial surgery

Follow up T4 - 3 year after initial surgery/end of study

Performing a three-dimensional ultrasonography to measure tumour volume and breast volume. The volume ratio will be translated using a prediction model aiming for superior cosmetic results in breast cancer patients opting for breast conserving surgery.