Breast Neoplasm Malignant Female Clinical Trial
Official title:
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
Status | Recruiting |
Enrollment | 92 |
Est. completion date | December 30, 2029 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 40 Years to 70 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). |
Country | Name | City | State |
---|---|---|---|
Italy | IEO Istituto Europeo di Oncologia | Milan | |
Italy | A.O.U. Pisana - Ospedale Santa Chiara | Pisa | |
Spain | Complejo Hospitalario Universitario A Coruña | A Coruña |
Lead Sponsor | Collaborator |
---|---|
Tensive SRL |
Italy, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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