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

Sponsor

UNICANCER (Other)

Overall Status

Completed

CT.gov ID

NCT02324088

Collaborator

(none)

174

Enrollment

Arms

171

Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Breast Cancer	Drug: Docetaxel Drug: Cyclophosphamide Drug: Epirubicin	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

174 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2000

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Jan 1, 2015

Arms and Interventions

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: Cyclophosphamide Drug: Epirubicin
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: Cyclophosphamide Drug: Epirubicin

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: Cyclophosphamide

Drug: Epirubicin

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: Cyclophosphamide

Drug: Epirubicin

Outcome Measures

Primary Outcome Measures

disease-free survival rate [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

UNICANCER

Investigators

Principal Investigator: Patrice Viens, MD, Institut Paoli Calmette Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

UNICANCER

ClinicalTrials.gov Identifier:

NCT02324088

Other Study ID Numbers:

PEGASE 7/0002

First Posted:

Dec 24, 2014

Last Update Posted:

Feb 21, 2021

Last Verified:

Feb 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Inflammatory Breast Neoplasms

Cyclophosphamide

Docetaxel

Epirubicin

Study Results

No Results Posted as of Feb 21, 2021