Can a new implant rebuild the breast right after lumpectomy?
NCT ID NCT05941299
First seen Jul 22, 2026 · Last updated Jul 23, 2026 · Updated 1 time
Summary
This trial tests a new breast implant called REGENERA in women aged 40–70 who are having a lumpectomy for early-stage breast cancer. The implant is placed during the same surgery to fill the gap left by the removed tumor. The study aims to see if the implant is safe and whether surgeons find it easy to use, while also checking that it does not interfere with standard breast cancer imaging like mammograms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a breast implant called REGENERA, made from a regenerative material, placed during lumpectomy surgery
- What this could lead to
- If safe and effective, REGENERA could offer a new option for breast reconstruction immediately after lumpectomy, potentially improving cosmetic outcomes without interfering with cancer follow-up imaging.
- What could go wrong
- This is an early-stage device trial with only 92 participants, so results may not apply to all patients. Risks include implant-related complications such as infection, implant failure, or interference with cancer surveillance.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 92 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2023
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 70 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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A.O.U. Pisana - Ospedale Santa Chiara
Pisa, 56126, Italy
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Complejo Hospitalario Universitario A Coruña
A Coruña, 15001, Spain
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ICS Maugeri IRCCS
Pavia, 27100, Italy
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IEO Istituto Europeo di Oncologia
Milan, 20141, Italy
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IRCCS Humanitas Istituto Clinico Catanese
Catania, 95045, Italy
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IRCCS Humanitas Research Hospital
Rozzano, Milano, 20089, Italy
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IRCCS Ospedale San Raffaele
Milan, 20132, Italy
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Istituto Oncologico di Candiolo FPO-IRCCS
Torino, 10060, Italy
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Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168, Italy
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