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Efficacy and Tolerance Study of Bevacizumab in Her2- Inflammatory Breast Cancer Patients

NCT00820547 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-10-22

No results posted yet for this study

Summary

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab and combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab and radiation therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase II trial is studying giving bevacizumab together with chemotherapy before surgery and bevacizumab and radiation therapy after surgery to see how well it works in treating patients with inflammatory breast cancer.

Conditions

Interventions

BIOLOGICAL

bevacizumab

During neoadjuvant phase: 15 mg/kg, d1 q3w, 8 cycles During adjuvant phase:15 mg/kg, d1 q3w, 10 cycles

DRUG

cyclophosphamide

Neoadjuvant: 500 mg/m2 d1 q3w, 4 cycles

DRUG

docetaxel

Neoadjuvant: 100 mg/m2 q3w, 4 cycles

DRUG

epirubicin hydrochloride

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

DRUG

fluorouracil

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

Sponsors & Collaborators

  • UNICANCER

    lead OTHER

Principal Investigators

  • Patrice Viens, MD · Institut Paoli-Calmettes

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2015-04-30
Completion
2019-09-30

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

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 NCT00820547 on ClinicalTrials.gov