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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
UNICANCER
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Breast Cancer

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept 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

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

    First Posted
    December 14, 2014
    Last Updated
    February 17, 2021
    Sponsor
    UNICANCER
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    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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