Ireland
--:--IST
Starting soon Not applicable

Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy

NCT06131632 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2024-03-01
Last updated
2024-01-23

Condition(s) studied

Inflammatory Breast Cancer

Investigational drug(s) / intervention(s)

Breast conserving surgeryRadical modified mastectomy

Breast conserving surgery: Remove only a small part of the breast

Radical modified mastectomy: Remove all the breast parenchyma, nipple and skin

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
70 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • local recurrence rate — 24 months
    Rate of recurrence in the breast parenchyma after conserving surgery vs radical mastectomy

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma Italy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06131632 on ClinicalTrials.gov ↗ ← All trials in Italy