Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy

Not Applicable

Not yet recruiting

• Conditions: Inflammatory Breast Cancer
• Interventions: Procedure: Breast conserving surgery; Procedure: Radical modified mastectomy

• Registration Number: NCT06131632
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-09
• Study First Submitted QC: 2023-11-09
• Study First Posted: 2023-11-14
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23
• Study Start: 2024-03-01
• Primary Completion: 2026-01-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• Patients with inflammatory breast cancer
• Clinical complete response after neoadjuvant chemiotherapy
• Targeted tumor
• Written informed consent

Exclusion Criteria

• Metastasis
• Progression disease
• Recurrent disease
• Contraindications to adjuvant radiation therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breast conserving surgery	Breast conserving surgery	-
Radical modified mastectomy	Radical modified mastectomy	-

Primary Outcome Measures

Name	Time	Method
local recurrence rate	24 months	Rate of recurrence in the breast parenchyma after conserving surgery vs radical mastectomy

Secondary Outcome Measures

Name	Time	Method
local recurrence-free survival	24 months	Rate of disease free survival after breast conserving surgery vs radical mastectomy
overall survival	24 months	overall survival after breast conserving surgery vs radical mastectomy

Trial Locations

Locations (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS,; 🇮🇹 Roma, Italy