Interest of Maintenance Chemotherapy After Induction Treatment for Inflammatory Breast Cancer (PEGASE07)
Primary Purpose
Inflammatory Breast Cancer
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Docetaxel
Cyclophosphamide
Epirubicin
Sponsored by
About this trial
This is an interventional treatment trial for Inflammatory Breast Cancer
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm A
Arm B
Arm 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
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)
Outcomes
Primary Outcome Measures
disease-free survival rate
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02324088
Brief Title
Interest of Maintenance Chemotherapy After Induction Treatment for Inflammatory Breast Cancer
Acronym
PEGASE07
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 Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
October 2000 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
174 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Active Comparator
Arm 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
Arm Title
Arm B
Arm Type
Experimental
Arm 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)
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Primary Outcome Measure Information:
Title
disease-free survival rate
Time Frame
3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrice Viens, MD
Organizational Affiliation
Institut Paoli Calmette Marseille
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
25943350
Citation
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.
Results Reference
result
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