Interest of Maintenance Chemotherapy After Induction Treatment for Inflammatory Breast Cancer

NCT02324088 | Completed Phase 3 DMC

• 1 other identifier: PEGASE 7/0002
• Study Type: interventional
• Target: 174
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Inflammatory Breast Cancer

Outcome Measures

Primary Outcomes (1)

• disease-free survival rate

  3 years

Study Arms (2)

Arm A

ACTIVE COMPARATOR

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

Drug: Cyclophosphamide; Drug: Epirubicin

Arm B

EXPERIMENTAL

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)

Drug: Docetaxel; Drug: Cyclophosphamide; Drug: Epirubicin

Interventions

Docetaxel DRUG

Arm B

Cyclophosphamide DRUG

Arm A; Arm B

Epirubicin DRUG

Arm A; Arm B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• UNICANCER: lead

Related Publications (1)

• Goncalves 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 RESULT

MeSH Terms

Conditions

Inflammatory Breast Neoplasms

Interventions

Docetaxel; Cyclophosphamide; Epirubicin

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Patrice Viens, MD

  Institut Paoli Calmette Marseille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2014
• First Posted: December 24, 2014
• Study Start: October 1, 2000
• Primary Completion: December 1, 2012
• Study Completion: January 1, 2015
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Unicancer will consider access to study data upon written detailed request sent to Unicancer, from 6 months until 5 years after publication of summary data.
• Access Criteria: The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement.