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

February 17, 2021 updated by: UNICANCER

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UNICANCER

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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