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

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

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

Study Overview

• Status: Recruiting
• Conditions: Breast Neoplasm Malignant Female; Mastectomy, Segmental
• Intervention / Treatment: Device: REGENERA breast implant implantation

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Margherita Tamplenizza; Phone Number: +39 0256660185; Email: margherita.tamplenizza@tensivemed.com

Study Locations

• Italy
  • Milan, Italy, 20141
    • Recruiting
    • Ieo Istituto Europeo Di Oncologia
    • Contact: Mario Rietjens
  • Pisa, Italy, 56126
    • Recruiting
    • A.O.U. Pisana - Ospedale Santa Chiara
    • Contact: Manuela Roncella
• Spain
  • A Coruña, Spain, 15001
    • Recruiting
    • Complejo Hospitalario Universitario A Coruna
    • Contact: Benigno Acea Nebril

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: REGENERA breast implant implantation	Device: REGENERA breast implant implantation; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tensive SRL

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 30, 2029

Study Registration Dates

• First Submitted: June 16, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 12, 2023

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Site; Breast Diseases; Neoplasms; Breast Neoplasms
• Other Study ID Numbers: Tens-BBC/003/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No