Interest of Maintenance Chemotherapy After Induction Treatment for Inflammatory Breast Cancer

Inflammatory Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02324088
• Other study ID #: PEGASE 7/0002
• Status: Completed
• Phase: Phase 3
• Start date: October 2000
• Est. completion date: January 2015

Study information

• Verified date: February 2021
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: January 2015
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Inflammatory Breast Cancer

Intervention

Drug:
• Docetaxel

• Cyclophosphamide

• Epirubicin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

References & Publications (1)

Gonçalves 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, Roché H. UNICANCER-PEGASE 07 study: a randomized phase III — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival rate		3 years