Trial | NCT02324088  Report issue

Title

Interest of Maintenance Chemotherapy After Induction Treatment for Inflammatory Breast Cancer
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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    174
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).
Study Started
Oct 31
2000
Primary Completion
Dec 31
2012
Study Completion
Jan 31
2015
Last Update
Feb 21
2021

Drug Docetaxel

Drug Cyclophosphamide

Drug Epirubicin

Arm A Active Comparator

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

Arm B Experimental

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)

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
No Results Posted