Interest of Maintenance Chemotherapy After Induction Treatment for Inflammatory Breast Cancer

Study Overview
=================
Brief Summary
-----------------
To evaluate the benefit of adding docetaxel-5 fluorouracile (D-5FU) regimen after pre-operative epirubicin-cyclophosphamide (EC) and loco-regional treatment in inflammatory breast cancer (IBC).

Official Title
-----------------
Phase III Trial Assessing the Interest of a Maintenance Chemotherapy Combining Docetaxel (Taxotere) 5-FU After Induction Treatment by Aintensive Chemotherapy for Inflammatory Breast Cancers

Conditions
-----------------
Inflammatory Breast Cancer

Intervention / Treatment
-----------------
* Drug: Docetaxel
* Drug: Cyclophosphamide
* Drug: Epirubicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically proven breast cancer inflammatory breast cancer no metastatic site age > or = 18 and < or = 60 OMS score: 0, 1, 2 life expectancy > or = 3 months Normal (isotopic or ultrasonography) left ventricular ejection fraction Normal haematological, liver, and kidney functions patients who gave their written informed consent. Exclusion Criteria: non inflammatory breast tumour with a cutaneous permeation nodule presence of a metastatic site medical history of a cancerous tumour except for carcinoma in situ of the uterine cervix, a basal cell skin cancer, or a breast carcinoma on the contralateral side patients having already had a chemotherapy, a radiotherapy, or an hormone therapy for this breast tumour medical history of congestive heart failure even medically controlled medical history of myocardial infarction during the 6 months before the inclusion in the study active infection or other severe underlying pathology which could possibly prevent the patient from receiving treatments administration of another chemotherapy during the study pregnant or breast feeding patients (the patients of childbearing age must be placed under efficient contraception) patients whose social or psychological state does not allow to consider a correct adherence to the treatment and to the required medical follow-up WHO score 3,4 unbalanced diabetes polysorbate 80 allergy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm A<br>4 cycles of high-dose EC (E150 mg/m² and C 4000 mg/m² every 3 weeks) then mastectomy with axillary lymph node dissection and radiotherapy | Drug: Cyclophosphamide<br> <br> Drug: Epirubicin<br> <br> |
| Experimental: Arm B<br>4 cycles of high-dose EC (E150 mg/m² and C 4000 mg/m² every 3 weeks) then mastectomy with axillary lymph node dissection and radiotherapy followed by 4 cycles of D-5FU (D 85 mg/m², day 1 and 5FU 2500 mg/m²/day continuous infusion, days 1-5 every 3 weeks) | Drug: Docetaxel<br> <br> Drug: Cyclophosphamide<br> <br> Drug: Epirubicin<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| disease-free survival rate |  | 3 years |