Clinical trial · Interventional

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

NCT02324088CI-TRIAL-00050225PEGASE07completedPhase 3ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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).

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Inflammatory Breast Cancer	Breast Inflammatory Carcinoma	ALIAS	0.90

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
Cyclophosphamide	Drug	Cyclophosphamide	ALIAS
Docetaxel	Drug	Docetaxel	ALIAS
Epirubicin	Drug	Epirubicin	ALIAS

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
Arm A
description
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
interventionNames
1. Drug: Cyclophosphamide
2. Drug: Epirubicin
type
EXPERIMENTAL
label
Arm B
description
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)
interventionNames
1. Drug: Docetaxel
2. Drug: Cyclophosphamide
3. Drug: Epirubicin

Primary outcomes (1)

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years
Maximum age: 60 Years

Show eligibility criteria text

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

References

Publications (1)

RESULTGoncalves 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, Roche H. UNICANCER-PEGASE 07 study: a randomized phase III trial evaluating postoperative docetaxel-5FU regimen after neoadjuvant dose-intense chemotherapy for treatment of inflammatory breast cancer. Ann Oncol. 2015 Aug;26(8):1692-7. doi: 10.1093/annonc/mdv216. Epub 2015 May 5. PMID 25943350