Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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 criteria

Qualifiers

Patients with inflammatory breast cancer

Clinical complete response after neoadjuvant chemiotherapy

Targeted tumor

Written informed consent

Disqualifiers

Metastasis

Progression disease

Recurrent disease

Contraindications to adjuvant radiation therapy

Trial design

Treatments tested in this trial

  • Breast conserving surgery
  • Radical modified mastectomy

Treatment groups

300 Participants
are divided into 2 treatment groups