Status:
COMPLETED
Implant-based Breast Reconstruction and Mastectomy With Fat Grafting After Breast Conserving Surgery and Radiotherapy
Lead Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborating Sponsors:
Morgagni Pierantoni Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief Summary
Higher rates of complications and poorer cosmetic outcomes have been reported after salvage mastectomy and implant-based versus autologous reconstruction in patients previously exposed to radiation th...
Detailed Description
National Comprehensive Cancer Network guidelines recommend autologous reconstruction as the preferred breast reconstruction after mastectomy in previously irradiated patients because of higher complic...
Eligibility Criteria
Inclusion
- patients candidate to mastectomy (salvage mastectomy for breast cancer recurrence or prophylactic mastectomy) who had been irradiated as adjuvant treatment after breast conserving surgery or as treatment for Hodgkin lymphoma
- signed informed consent to participate and to implant-based breast reconstruction
- absence of distant metastases or other malignancies.
Exclusion
- \- presence of distant metastases or other malignancies.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
163 Patients enrolled
Trial Details
Trial ID
NCT06119633
Start Date
June 1 2007
End Date
December 1 2023
Last Update
March 8 2024
Active Locations (2)
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1
Morgagni Pierantoni Hospital
Forlì, Italy, 47121
2
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy, 20133