Overview

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