Clinical Trial to Demonstrate the Safety and Performance of REGENERA Breast Implant in 40-70 Years Old Women Affected by Malignant Breast Lesion Treated by Lumpectomy

Study Overview
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Brief Summary
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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

Official Title
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A Pivotal Study of REGENERA Implant in Malignant Breast Lesion Treated by Lumpectomy

Conditions
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Mastectomy, Segmental, Breast Neoplasm Malignant Female

Intervention / Treatment
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* Device: REGENERA breast implant implantation


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REGENERA breast implant implantation<br> | Device: REGENERA breast implant implantation<br>* Each patient 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse events (AEs) with a causal relationship to REGENERA at 3 months. | The rate of AEs with a causal relationship to REGENERA should be <5% at 3 months after implant. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean investigator's satisfaction on the implanting procedure at 1week. | At least 7 in a 0-10 Visual Analogue Scale, VAS. | 1 week after implant | 
| Mean investigator's satisfaction on REGENERA usability during surgery at 1 week. | At least 40 in an ad hoc questionnaire (12-60 scale). | 1 week after implant | 
| Mean investigator's satisfaction on overall surgical procedure and clinical outcome of the patient at 12 months. | At least 7 in a 0-10 Visual Analogue Scale, VAS. | 12 months | 
| Number of interference events of REGENERA with ultrasound imaging technique, through the completion of a questionnaire by the investigators. | An imaging evaluation questionnaire will be provided for investigators to fill out. | After 6 and 12 months | 
| Number of interference events of REGENERA with mammography imaging technique, through the completion of a questionnaire by the investigators. | An imaging evaluation questionnaire will be provided for investigators to fill out. | After 12 months | 
| Number of interference events of REGENERA with MRI (with and without contrast) imaging technique, through the completion of a questionnaire by the investigators. | An imaging evaluation questionnaire will be provided for investigators to fill out. | After 6 and 18 months | 
| Rate of serious adverse events (SAEs) with a causal relationship to REGENERA after 3 months and up to 18 months. | The rate of REGENERA-related SAEs should be <5% at each follow-up after 3 months and up to 18 months. | After 3 months and up to 18 months | 
| Rate of SAEs with a causal relationship to REGENERA after 18 months and up to 5 years. | The rate of REGENERA-related SAEs should be <7% at each follow-up after 18 months and up to 5 years. | After 18 months and up to 5 years |