An interventional study of Breast conserving surgery and Radical modified mastectomy in Inflammatory Breast Cancer, sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Not yet recruiting at 1 site in Italy. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-23.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Not applicable, Interventional, and Treatment
Inflammatory breast cancer is an aggressive and rare form of breast cancer, which accounts for 2-3% of all breast cancers. The classic presentation of inflammatory breast cancer includes erythema, edema, and peau d'orange of at least one/third of the breast.
Current treatment of inflammatory breast cancer include: neoadjuvant chemiotherapy, modified radical mastectomy and radiation therapy.
In the last two decades the development of new targeted therapies has significantly improved the efficacy of neoadjuvant chemiotherapy allowing a de-escalation of surgical treatment in patients with non-inflammatory breast cancer that achieve clinical complete response.
There are few retrospective studies that evaluate implications of surgical treatment on survival among these patients. This may justify trial aims to investigate the possible use of the breast conserving surgery in patients with inflammatory breast cancer that achieve clinical complete response after neoadjuvant chemiotherapy.
Exclusion Criteria:
Procedure: Breast conserving surgery
Procedure: Radical modified mastectomy
Remove only a small part of the breast
Remove all the breast parenchyma, nipple and skin
local recurrence rate
Rate of recurrence in the breast parenchyma after conserving surgery vs radical mastectomy
Time frame: 24 months
local recurrence-free survival
Rate of disease free survival after breast conserving surgery vs radical mastectomy
Time frame: 24 months
overall survival
overall survival after breast conserving surgery vs radical mastectomy
Time frame: 24 months
This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS