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Trial Title:
Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy
NCT ID:
NCT06131632
Condition:
Inflammatory Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Inflammatory Breast Neoplasms
Conditions: Keywords:
inflammatory breast cancer
breast conserving surgery
radical mastectomy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Breast conserving surgery
Description:
Remove only a small part of the breast
Arm group label:
Breast conserving surgery
Intervention type:
Procedure
Intervention name:
Radical modified mastectomy
Description:
Remove all the breast parenchyma, nipple and skin
Arm group label:
Radical modified mastectomy
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.
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Fondazione Policlinico Universitario A. Gemelli IRCCS,
Address:
City:
Roma
Zip:
00168
Country:
Italy
Contact:
Last name:
GIANLUCA FRANCESCHINI
Phone:
+390630155701
Email:
gianluca.franceschini@policlinicogemelli.it
Contact backup:
Last name:
Lorenzo Scardina
Investigator:
Last name:
GIANLUCA FRANCESCHINI
Email:
Principal Investigator
Start date:
March 1, 2024
Completion date:
January 1, 2028
Lead sponsor:
Agency:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class:
Other
Source:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06131632
