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NCT06119633Completed

Implant-based Breast Reconstruction and Mastectomy With Fat Grafting After Breast Conserving Surgery and Radiotherapy

Immediate Tissue Expander and Lipofilling After Mastectomy for Breast Cancer Recurrence Following Lumpectomy and Irradiation: Retrospective Multicentric Clinical Trial

Source: ClinicalTrials.gov · Last updated 8 Mar 2024

Brief summary (registry, in English)

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 therapy (i) on the breast as adjuvant treatment after breast conserving surgery (BCS) or (ii) on thoracic wall for Hodgkin Lymphoma (HL). Nevertheless, selected patients with favourable preoperative soft-tissue assessment may benefit from alloplastic reconstruction and fat grafting that has been suggested as an effective technique to promote the regeneration of irradiated tissues. The aims of this study are to assess: 1. the feasibility of implant-based breast reconstruction and fat grafting after mastectomy (simple mastectomy, nipple-sparing and skin-sparing mastectomy) 2. oncological safety of implant-based breast reconstruction and fat grafting.

Status (registry)
Completed
Study type
Interventional
Enrollment
163 (actual)
First submitted
30 Oct 2023
Start date
Jun 2007
Primary completion date
Dec 2023
Lead sponsor
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
NCT number
NCT06119633

What you commit to

  • Study type: Interventional
  • Participants enrolled: 163
  • From Jun 2007 to the primary completion date, Dec 2023
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • \- presence of distant metastases or other malignancies.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Morgagni Pierantoni Hospital
Coordinator of this site? Confirm its status
ForlìItalyUnknown status
Fondazione IRCCS - Istituto Nazionale dei Tumori
Coordinator of this site? Confirm its status
MilanItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.