Inflammatory Breast Cancer
Conditions
Keywords
inflammatory breast cancer, breast conserving surgery, radical mastectomy
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.
Interventions
PROCEDUREBreast conserving surgery
Remove only a small part of the breast
PROCEDURERadical modified mastectomy
Remove all the breast parenchyma, nipple and skin
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| local recurrence rate | 24 months | Rate of recurrence in the breast parenchyma after conserving surgery vs radical mastectomy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed