Clinical trials

To investigate clinical outcomes, late side effects, and cosmetic results of a single-fraction very accelerated partial breast irradiation as postoperative local treatment for the treatment of early stage breast cancer.

Observational investigation of participants who are given neoadjuvant treatment for invasive breast cancer. The scope of the study is to collect information on standardized treatment results, to explore the causes of dose modification and its effect on efficacy, to explore potential prognostic factors, and to explore the long-term side effects of different treatment modalities.

This is a response-adaptive (RAR) prospective randomized study with a long-term follow-up and the aim of this clinical study is to measure with qualitative and quantitative indicators the changes in cosmetic results, quality of life and patient satisfaction after breast reconstructive surgery with silicone implant (following SSM, ASM or NSM mastectomy) and symmetrization (mastopexy and/or silicone implant and/or Ultrapro mesh sling technique) over time. According to the hypothesis of the study, the results of implant-based breast reconstruction and symmetrization following advanced postmastectomy techniques significantly decrease over time and later results limited patient satisfaction rate. This is mainly due to the fact that over time, the natural breast differs from the reconstructed breast with silicone implant. Because of the different biological properties (gravity results ptosis on breast with mastopexy, significant volume increasement of the breast with mastopexy due to endocrine therapy, gradually progressive capsular contracture on the tumorous side, nipple flattening, nipple tattoo fading etc.) the two sides change differently resulting in significant asymmetry and consequently could lead to decreased patient satisfaction. The high degree of asymmetry over time (which can be similar to the difference between the result of a simple mastectomy and natural breast (control group)), may indicates additional surgeries or usage of medical devices, putting a financial burden on the patient and the health system. On the other hand, the symmetry can be achieved with bilateral skin-sparing mastectomies and implant-based immediate or delayed-immediate reconstructions is clearly better and change less with time. The mastectomy of the contralateral disease-free side is considered as an unreasonable burden for moderate risk patients. The information such as the need for multiple surgeries, change in symmetry over time etc., should be an important part of the professional decision-making mechanism and the surgeon should inform the patient during the primer surgery. Nowadays due to the lack of evidence-based knowledge, it is not part of the patient's information and surgical planning internationally. Planning breast units, attention, capacity and financial resources must also be provided to meet the long-term needs of patients who underwent postmastectomy breast reconstruction. Simple mastectomy with an external prosthesis can be an alternative for patients with intolerable degree of asymmetry or on the contrary, the results may justify the need for bilateral mastectomy and reconstruction even in the absence of high oncological risk and for purely symmetrical and cosmetic reasons.

This is a response-adaptive (RAR) prospective randomized study with a long-term follow-up and the aim of this clinical study is to measure with qualitative and quantitative indicators the changes in cosmetic results, quality of life and patient satisfaction after delayed- immediate breast reconstruction with standardized technique Skin Reducing Nipple sparing mastectomy, SRNSM and SSM with standardized horizontal skin incision. According to our hypothesis, SRNSM with standardized technique on pendulous/ ptotic breasts is a safe procedure compared to SSM. It also promotes the cosmetic efficacy of SRNSM with the removal of the entire glandular tissue through avoidance of the reduction of projection, the need later nipple reconstruction surgery and of areola tattoo. In our study we propose that compared to one of the well-known and widely investigated studied SSM, our current standardized SRNSM technique is able to perform similar oncologically safe entire gland tissue removal, with low complication rate, accommodating for adjuvant treatments. Furthermore, it may provide superior cosmetic results than SSM (NAC is not removed, projection is maintained, and there is no need for further nipple reconstruction or tattoo) with high patient satisfaction which is maintained long term.

The aim of this clinical study is to analyze due long term follow-up, the clinical, oncological, aesthetic results and patients' reported quality of life and satisfaction in a responsive-adaptive (RAR) prospective, randomized study at a large number of patients whom receive round-block and retroglandular oncoplastic breast conserving surgeries. According to the study's hypothesis, breast conserving surgery can be oncologically successful and safe with low complication rates resulting in high rate of patient satisfaction and good quality of life, which can be maintained for a long time after WBI with the application of modern oncoplastic breast conserving surgeries. We assume in this study that against of the earliest and mostly studied round-block oncoplastic surgery, the retroglandular technique, firstly reported in the literature by the current authors, is also adequate for oncologically safe, radical tumor removal that comes with low complication rates, suited for adjuvant treatments and able to offer better cosmetic results (NAC does not distorted, and pathological scar will not develop) than round-block OPS and high rate of patient's satisfaction that can be maintained for long-term.