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NCT06131632 Clinical Trial

Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy

Inflammatory Breast Cancer Clinical Trial

— ConSIBreC  

Official title:
Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy in Patients With Clinical Complete Response (ConSIBreC): a Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06131632
Other study ID # Consibrec Trial
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 1, 2024
Est. completion date January 1, 2028

Study information
Verified date November 2023
Source Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 300
Est. completion date January 1, 2028
Est. primary completion date January 1, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Breast conserving surgery
Remove only a small part of the breast
• Radical modified mastectomy
Remove all the breast parenchyma, nipple and skin

Locations
Country Name City State
Italy Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma

Sponsors (1)
Lead Sponsor Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary local recurrence rate Rate of recurrence in the breast parenchyma after conserving surgery vs radical mastectomy 24 months
Secondary local recurrence-free survival Rate of disease free survival after breast conserving surgery vs radical mastectomy 24 months
Secondary overall survival overall survival after breast conserving surgery vs radical mastectomy 24 months
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