Preoperative Radiation Therapy and Immediate Breast Reconstruction

"In this study the patients assigned to the experimental treatment arm will receive preoperative radiotherapy instead of postoperative radiotherapy.~This preoperative radiotherapy will follow the standard of care (SoC) principles as they are defined for postoperative radiotherapy in breast cancer, as defined by international guidelines."

Standard of care (SoC) postoperative radiotherapy, as defined by international guidelines.

In the experimental arm of the PRADAIIBE, the participants will undergo immediate breast reconstruction surgery. This is defined as breast reconstruction taking place at the same time as oncological surgery. Using one of the following primary techniques: 1) Autologous tissue reconstruction (1 phase); 2) Tissue expander and autologous tissue reconstruction (2 phases); 3) Breast implant based reconstruction (1 phase); 4) Tissue expander and breast implant based reconstruction (2 phases); 5) Combined autologous tissue and breast implant reconstruction (1 phase); 6) Tissue expander and combined autologous tissue and breast implant reconstruction (2 phases). Adjuvant techniques are allowed to be added.

In the standard arm of the PRADAIIBE, the participants will undergo immediate or delayed breast reconstruction surgery. This is defined as breast reconstruction taking place at the same time as oncological surgery (immediate), or at a later time (delayed). Using one of the following primary techniques: 1) Autologous tissue reconstruction (1 phase); 2) Tissue expander and autologous tissue reconstruction (2 phases); 3) Breast implant based reconstruction (1 phase); 4) Tissue expander and breast implant based reconstruction (2 phases); 5) Combined autologous tissue and breast implant reconstruction (1 phase); 6) Tissue expander and combined autologous tissue and breast implant reconstruction (2 phases). Adjuvant techniques are allowed to be added.