Interest of Maintenance Chemotherapy After Induction Treatment for Inflammatory Breast Cancer

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNICANCER
• Treatments: Cyclophosphamide; Docetaxel; Epirubicin

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