MedTrace Logo

A Study of Avastin (Bevacizumab) in Patients With Inflammatory or Locally Advanced Breast Cancer

NCT00559845 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2018-04-09

Study results available
· View outcomes & findings →

Summary

This single arm study will assess the efficacy and safety of sequential neoadjuvant chemotherapy and bevacizumab (Avastin), before surgery and/or radiotherapy, in participants with inflammatory or locally advanced operable breast cancer. Participants will receive 5-fluorouracil, epidoxorubicin and cyclophosphamide (FEC), followed by paclitaxel, given concomitantly with bevacizumab. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Conditions

Interventions

DRUG

5-fluorouracil

600 milligrams per meter squared (mg/m\^2) as an intravenous (i.v.) bolus over ≤15 minutes every 3 weeks for 4 cycles.

DRUG

Epidoxorubicin

90 mg/m\^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles.

DRUG

Cyclophosphamide

600 mg/m\^2 as an i.v. infusion over 1 hour every 3 weeks for 4 cycles.

DRUG

Paclitaxel

Paclitaxel was administered at 80 mg/m\^2 i.v. over 1 hour weekly for 12 weeks.

BIOLOGICAL

Bevacizumab

Bevacizumab was administered at 10 milligrams per kilogram (mg/kg) i.v. every 2 weeks for 6 cycles.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT00559845 on ClinicalTrials.gov