Interest of Maintenance Chemotherapy After Induction Treatment for Inflammatory Breast Cancer

NCT ID: NCT02324088

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-10-31
• Study Completion Date: 2015-01-31

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).

Conditions

Inflammatory Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A

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

Group Type: ACTIVE_COMPARATOR

Cyclophosphamide

Intervention Type: DRUG

Epirubicin

Intervention Type: DRUG

Arm B

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)

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

Cyclophosphamide

Intervention Type: DRUG

Epirubicin

Intervention Type: DRUG

Interventions

Docetaxel

Intervention Type: DRUG

Cyclophosphamide

Intervention Type: DRUG

Epirubicin

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

UNICANCER

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrice Viens, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Paoli Calmette Marseille

References

Goncalves A, Pierga JY, Ferrero JM, Mouret-Reynier MA, Bachelot T, Delva R, Fabbro M, Lerebours F, Lotz JP, Linassier C, Dohollou N, Eymard JC, Leduc B, Lemonnier J, Martin AL, Boher JM, Viens P, Roche H. UNICANCER-PEGASE 07 study: a randomized phase III trial evaluating postoperative docetaxel-5FU regimen after neoadjuvant dose-intense chemotherapy for treatment of inflammatory breast cancer. Ann Oncol. 2015 Aug;26(8):1692-7. doi: 10.1093/annonc/mdv216. Epub 2015 May 5.

Reference Type: RESULT

PMID: 25943350 (View on PubMed)

Other Identifiers

PEGASE 7/0002

Identifier Type: -

Identifier Source: org_study_id