Safety and performance of a new breast implant for women after lumpectomy for breast cancer
A Pivotal Study of REGENERA Implant in Malignant Breast Lesion Treated by Lumpectomy
This study is testing a new breast implant to see if it's safe and effective for women who have had surgery to remove breast cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 40 Years to 70 Years |
| Sex | Female |
| Sponsor | Tensive SRL Industry-sponsored |
| Drugs / interventions | chemotherapy |
| Locations | 3 sites (Milan and 2 other locations) |
| Trial ID | NCT05941299 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety and performance of the REGENERA breast implant in women who have undergone lumpectomy for malignant breast lesions. Participants will undergo a series of 13 study visits, which include screening, pre-surgery treatment, surgery for implant placement, and post-surgery follow-up lasting up to five years. The study will assess the implant's impact on standard imaging techniques and monitor for any serious adverse events related to the device.
Who should consider this trial
Good fit: Ideal candidates are women aged 40-70 diagnosed with a specific type of malignant breast lesion suitable for conservative surgery.
Not a fit: Patients with benign breast lesions or those not eligible for breast-conserving surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safe and effective option for breast reconstruction after lumpectomy, improving patient satisfaction and outcomes.
How similar studies have performed: Other studies have shown promising results with similar breast implant approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Milan and 2 other locations
- IEO Istituto Europeo di Oncologia — Milan, Italy (Recruiting)
- A.O.U. Pisana - Ospedale Santa Chiara — Pisa, Italy (Recruiting)
- Complejo Hospitalario Universitario A Coruña — A Coruña, Spain (Recruiting)
Study contacts
- Study coordinator: Margherita Tamplenizza
- Email: margherita.tamplenizza@tensivemed.com
- Phone: +39 0256660185
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.