Interest of Maintenance Chemotherapy After Induction Treatment for Inflammatory Breast Cancer

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02324088

Acronym

PEGASE07

Enrollment

174

Registered

2014-12-24

Start date

2000-10-31

Completion date

2015-01-31

Last updated

2021-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Breast Cancer

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).

Interventions

DRUGDocetaxel

DRUGCyclophosphamide

DRUGEpirubicin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
disease-free survival rate	3 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026