Robotic Nipple Sparing Mastectomy with Immediate Reconstruction
Launched by EUROPEAN INSTITUTE OF ONCOLOGY · Feb 28, 2025
Trial Information
Current as of July 26, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new way to perform a surgery called nipple-sparing mastectomy, which is used to treat breast cancer. The goal is to see if using a robotic technique for this surgery, along with immediate breast reconstruction, can improve patients' quality of life and recovery. Researchers want to find out if this less invasive method can lead to better outcomes during and after surgery, and whether it affects the overall results for patients with breast cancer, including those with specific genetic factors like BRCA mutations.
To be eligible for this trial, participants should be candidates for nipple-sparing mastectomy and immediate breast reconstruction, and they can be of any age and gender. They must also have a negative assessment of the nipple area before surgery and should not have certain conditions, such as previous radiation therapy to the chest or inflammatory breast cancer. Participants can expect to receive thorough care and regular follow-ups throughout the study, and they will need to provide written consent to join. This trial is currently not recruiting participants, but it aims to gather important information that could help improve breast cancer treatment in the future.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Candidates to nipple-sparing mastectomy and immediate breast reconstruction for invasive breast cancer, ductal carcinoma in situ (DCIS), BReast CAncer gene (BRCA) mutation carriers
- • Any age
- • Negative preoperative assessment of nipple-areola complex
- • Absence of skin involvement
- • Low probability to have positivity of nipple-areola complex tissue intra-operative frozen section
- • Breast volume ≤ Bra IV
- • No hard smoking (defined as \<=20 cigarettes/day)
- • Low and intermediate risk for anesthesia (American Society of Anesthesiologists (ASA) Scale)
- • Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.
- • Patients must be accessible for follow-up
- Exclusion Criteria:
- • Previous thoracic radiation therapy for any reason
- • Inflammatory Breast Cancer
- • Pregnancy
- • Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study.
- • Uncompensated Diabetes Mellitus
About European Institute Of Oncology
The European Institute of Oncology (IEO) is a leading research and treatment center based in Milan, Italy, dedicated to advancing cancer care through innovative clinical research and personalized medicine. Renowned for its commitment to multidisciplinary approaches, IEO integrates cutting-edge research with clinical practice to improve patient outcomes. The institute actively sponsors and conducts clinical trials across various cancer types, fostering collaboration between oncologists, researchers, and industry partners. With a focus on translating scientific discoveries into effective therapies, IEO plays a pivotal role in the global fight against cancer, contributing to the development of new treatment protocols and enhancing the understanding of oncological diseases.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Milan, , Italy
Patients applied
Trial Officials
Paolo Veronesi, MD
Principal Investigator
European Istitute of Oncology
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported