Safety and Performance of REGENERA Breast Implant in Women Affected by Malignant Breast Lesion Treated by Lumpectomy

This study is evaluating a new breast implant called REGENERA to restore breast shape after lumpectomy (partial breast removal) for early-stage breast cancer, reducing the need for more invasive reconstruction. **You may be eligible if...** - You are a woman between 40 and 70 years old - You have been diagnosed with a single or multi-focal malignant breast lesion (cancer) in one breast only, without microcalcifications - Your tumor is contained within an area no larger than 4 cm - Your cancer has not spread to other organs (non-metastatic, M0) - You are scheduled for lumpectomy **You may NOT be eligible if...** - Your cancer has spread to other parts of the body - You have cancer in both breasts - You require a full mastectomy - You have had prior breast implants or extensive breast surgery - You have conditions that impair wound healing Talk to your doctor to see if this trial is right for you.