Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy

NCT06131632 | Not Yet Recruiting

• 1 other identifier: Consibrec Trial
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammatory Breast Cancer

Keywords

inflammatory breast cancer; breast conserving surgery; radical mastectomy

Outcome Measures

Primary Outcomes (1)

• local recurrence rate

  Rate of recurrence in the breast parenchyma after conserving surgery vs radical mastectomy

  24 months

Secondary Outcomes (2)

• local recurrence-free survival

  24 months

• overall survival

  24 months

Study Arms (2)

Breast conserving surgery

EXPERIMENTAL

Procedure: Breast conserving surgery

Radical modified mastectomy

ACTIVE COMPARATOR

Procedure: Radical modified mastectomy

Interventions

Breast conserving surgery PROCEDURE

Remove only a small part of the breast

Breast conserving surgery

Radical modified mastectomy PROCEDURE

Remove all the breast parenchyma, nipple and skin

Radical modified mastectomy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS,

Roma, 00168, Italy

Location

MeSH Terms

Conditions

Inflammatory Breast Neoplasms

Interventions

Mastectomy, Segmental; Mastectomy, Modified Radical

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative; Mastectomy, Radical

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 14, 2023
• Study Start: March 1, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 23, 2024

Record last verified: 2023-11

Locations

IT (1)