Overview
The goals of this clinical trial are:
- demonstrate the safety of REGENERA breast implant in patients undergoing lumpectomy of malignant breast lesions
- demonstrate the safety and performance of REGENERA in terms of investigator's satisfaction, potential interference with current standard-of-care imaging techniques and occurrence of device-related serious adverse events.
Participants will perform 13 study visits, and at each visit, all necessary study procedures will be performed according to the clinical investigation plan:
- Screening
- Pre-surgery treatment
- Surgery and study device implant
- Post-surgery follow-up up to 5 years
Eligibility
Inclusion Criteria:
- Female adult subject aged 40-70 years.
- Subject diagnosed with malignant breast lesion:
- monolateral nodular infiltrative carcinoma,
- without microcalcification,
- single or multifocal,
- included in an area with a maximum diameter of 4 cm,
- non-metastatic (M0).
- Subject with clinically negative axilla.
- Subject considered eligible for conservative breast surgery - BCS (Breast-Conserving Surgery, lumpectomy or quadrantectomy), leaving a volume deficit compatible with a REGENERA implant (available in two dried sizes) volume of 70 ml or 100 ml.
- Confirmation of malignant lesion (pT1, pT2, pN0, pN1) with no discordance between biopsy and radiological imaging.
- Adequate hematopoietic functions.
- Good general health and mentally sound.
- Subject able and willing to give written informed consent form.
Exclusion Criteria:
- Subject with actual concomitant benign breast lesion (B2 and B3), unless present in the same mammary quadrant or in the contralateral breast.
- Subject with actual concomitant malignancies, lobular neoplasm, metastatic breast carcinoma, sarcoma, malignant phyllodes lesions, or Paget's disease.
- Axillary dissection planned as part of the breast lesion surgery.
- History of surgery, chemotherapy, neoadjuvant chemotherapy, or irradiation of the breast parenchyma object of the study.
- Skin retraction at the breast to be operated.
- Infection of the surgical site confirmed pre-operatively by clinical examination.
- Abnormal blood sugar and glycosylated hemoglobin.
- Hard smoker (more than 10 cigarettes a day).
- Acute or chronic severe renal insufficiency (creatinine values >180 μmol/l).
- History of severe asthma or allergies (including allergy to anesthetics or contrast media).
- Autoimmune disease.
- Subjects who are known to be carriers of BCRA mutation.
- Inability to undergo MRI or allergy to contrast media.
- Systemic infections in an active phase.
- Immunocompromised patients (HIV).
- Pregnant or breastfeeding woman or woman who has nursed a child within 3 months prior to enrolment in the study.
- Subject who has participated in another interventional study within the past 3 months.
- Subject who received immunosuppressant therapy in the last 3 months.
- History of substance abuse (drug or alcohol).
- Non-collaborative patients (severe physical disabilities or psychiatric disorders, as per specialist opinion).