Interest of Maintenance Chemotherapy After Induction Treatment for Inflammatory Breast Cancer

Phase 3

Completed

• Conditions: Inflammatory Breast Cancer
• Interventions: Drug: Cyclophosphamide; Drug: Docetaxel; Drug: Epirubicin

• Registration Number: NCT02324088
• Lead Sponsor: UNICANCER

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2000-10
• Primary Completion: 2012-12
• Study First Submitted: 2014-12-14
• Study First Submitted QC: 2014-12-23
• Study First Posted: 2014-12-24
• Study Completion: 2015-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 174

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A	Cyclophosphamide	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 A	Epirubicin	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	Cyclophosphamide	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)
Arm B	Docetaxel	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)
Arm B	Epirubicin	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)

Primary Outcome Measures

Name	Time	Method
disease-free survival rate	3 years