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OpenTrials
Completed

NCT Number: NCT02324088

Interest of Maintenance Chemotherapy After Induction Treatment for Inflammatory Breast Cancer

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).

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

docetaxel

Drug

Cyclophosphamide

Drug

Epirubicin

Drug

Primary outcomes

  1. disease-free survival rate

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

UNICANCER

Other

Registry information

Official study 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

Acronym: PEGASE07

Important dates

Study start
2000
Primary completion
2012
Study completion
2015
First posted
Dec 24, 2014
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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