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

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

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 Overview

• Status: Completed
• Conditions: Inflammatory Breast Cancer
• Intervention / Treatment: Drug: Docetaxel; Drug: Epirubicin; Drug: Cyclophosphamide

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: Epirubicin; Drug: Cyclophosphamide
Experimental: 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)	Drug: Docetaxel; Drug: Epirubicin; Drug: Cyclophosphamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
disease-free survival rate	3 years

Collaborators and Investigators

• Sponsor: UNICANCER
• Investigators: Principal Investigator: Patrice Viens, MD, Institut Paoli Calmette Marseille

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2000
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: December 14, 2014
• First Submitted That Met QC Criteria: December 23, 2014
• First Posted (Estimate): December 24, 2014

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Inflammatory Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Docetaxel; Cyclophosphamide; Epirubicin
• Other Study ID Numbers: PEGASE 7/0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
• IPD Sharing Time Frame: Unicancer will consider access to study data upon written detailed request sent to Unicancer, from 6 months until 5 years after publication of summary data.
• IPD Sharing Access Criteria: The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No