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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Notify MeKey information
Conditions
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
Cyclophosphamide
DrugEpirubicin
DrugPrimary outcomes
-
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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