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Efficacy and Safety of Bevacizumab in the Neodjuvant Treatment of Inflammatory Breast Cancer

NCT01880385 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2013-06-19

No results posted yet for this study

Summary

Multi-center, non randomised, open label, non controlled pilot study. Evaluating the treatment of bevacizumab in association with pre-operative chemotherapy, followed by surgery, adjuvant chemotherapy and radiotherapy in Patients with inflammatory breast cancer.

Conditions

  • Inflammatory Breast Cancer

Interventions

BIOLOGICAL

Bevacizumab

During neoadjuvant phase: 15 mg/kg, d1 q3w, 4 cycles

DRUG

Cyclophosphamide

Neoadjuvant: 500 mg/m2 d1 q3w, 4 cycles

DRUG

epirubicin hydrochloride

Neoadjuvant: 100 mg/m2, d1 q3w, 4 cycles

DRUG

fluorouracil

Neoadjuvant: 500 mg/m2, d1 q3w, 4 cycles

DRUG

Docetaxel

Adjuvant: 100 mg/m2 q3w, 4 cycles

BIOLOGICAL

Trastuzumab

Adjuvant: 8 mg/kg d1 in the 1st cycle then 6 mg/kg for d1 q3w, 17 cycles if tumor overexpress HER2

Sponsors & Collaborators

  • Hoffmann-La Roche

    collaborator INDUSTRY

  • Sanofi

    collaborator INDUSTRY

  • Association Tunisienne de lutte Contre le Cancer

    lead OTHER

Principal Investigators

  • amel mezlini, professor · Institut Salah Azaiz

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2013-09-30
Completion
2017-04-30

Countries

  • Tunisia

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01880385 on ClinicalTrials.gov