NCT06131632

Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Inflammatory Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Breast conserving surgery	Remove only a small part of the breast
PROCEDURE	Radical modified mastectomy	Remove all the breast parenchyma, nipple and skin

Timeline

• Start date: 2024-03-01
• Primary completion: 2026-01-01
• Completion: 2028-01-01
• First posted: 2023-11-14
• Last updated: 2024-01-23

Locations

1 site across 1 country: Italy