Interest of Maintenance Chemotherapy After Induction Treatment for Inflammatory Breast Cancer (PEGASE07)

Unicancer

Status and phase: Completed; Phase 3

Conditions: Inflammatory Breast Cancer

Treatments: Drug: Epirubicin; Drug: Docetaxel; Drug: Cyclophosphamide

Study type: Interventional

Funder types: Other

Identifiers

NCT02324088

PEGASE 7/0002

Details and patient eligibility

About

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).

Enrollment: 174 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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174 participants in 2 patient groups

Arm A

Active Comparator group

Description:

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

Treatment:

Drug: Epirubicin

Drug: Cyclophosphamide

Arm B

Experimental group

Description:

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)

Treatment:

Drug: Docetaxel

Drug: Epirubicin

Drug: Cyclophosphamide