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NOT YET RECRUITING
NCT06131632
NA

Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

View on ClinicalTrials.gov

Summary

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.

Official title: Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy in Patients With Clinical Complete Response (ConSIBreC): a Randomized Clinical Trial

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2024-03-01

Completion Date

2028-01-01

Last Updated

2024-01-23

Healthy Volunteers

Yes

Interventions

PROCEDURE

Breast conserving surgery

Remove only a small part of the breast

PROCEDURE

Radical modified mastectomy

Remove all the breast parenchyma, nipple and skin

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS,

Roma, Italy