Conserving Surgery in Inflammatory Breast Cancer After Neoadjuvant Chemotherapy

Study Overview
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Brief Summary
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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.

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

Conditions
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Inflammatory Breast Cancer

Intervention / Treatment
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* Procedure: Breast conserving surgery
* Procedure: Radical modified mastectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Breast conserving surgery<br> | Procedure: Breast conserving surgery<br>* Remove only a small part of the breast<br>|
| Active Comparator: Radical modified mastectomy<br> | Procedure: Radical modified mastectomy<br>* Remove all the breast parenchyma, nipple and skin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local recurrence rate | Rate of recurrence in the breast parenchyma after conserving surgery vs radical mastectomy | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| local recurrence-free survival | Rate of disease free survival after breast conserving surgery vs radical mastectomy | 24 months | 
| overall survival | overall survival after breast conserving surgery vs radical mastectomy | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inflammatory breast cancer, breast conserving surgery, radical mastectomy