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
This trial accepts healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Breast conserving surgery
Procedure/SurgeryRemove only a small part of the breast
Radical modified mastectomy
Procedure/SurgeryRemove all the breast parenchyma, nipple and skin
Treatment groups
Trial outcomes
Primary outcomes
local recurrence rate
Rate of recurrence in the breast parenchyma after conserving surgery vs radical mastectomy
Secondary outcomes
local recurrence-free survival
Rate of disease free survival after breast conserving surgery vs radical mastectomy
overall survival
overall survival after breast conserving surgery vs radical mastectomy
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: