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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02324088
Recruitment Status : Completed
First Posted : December 24, 2014
Last Update Posted : May 8, 2017
Information provided by (Responsible Party):

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2000
Primary Completion Date : December 2012
Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Docetaxel
U.S. FDA Resources

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

Primary Outcome Measures :
  1. disease-free survival rate [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02324088

Sponsors and Collaborators
Principal Investigator: Patrice Viens, MD Institut Paoli Calmette Marseille

Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT02324088     History of Changes
Other Study ID Numbers: PEGASE 7/0002
First Posted: December 24, 2014    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Breast Neoplasms
Inflammatory Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors