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A Study of Bevacizumab (Avastin) in Combination With Neoadjuvant Treatment Regimens in Participants With Primary Human Epidermal Growth Factor Receptor 2 (HER2) Negative Breast Cancer

NCT00773695 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-01-09

No results posted yet for this study

Summary

This study will evaluate the effect of bevacizumab in combination with chemotherapy or endocrine therapy, as preoperative treatment, in participants with HER2 negative breast cancer. Participants will be randomized to receive either chemotherapy (FEC100: Epirubicine 100 milligrams per square meter \[mg/m\^2\], 5-fluorouracil 600 mg/m\^2, and cyclophosphamide 600 mg/m\^2\] for 12 weeks followed by taxane (paclitaxel/docetaxel) for 12 weeks or endocrine therapy (an aromatase inhibitor\] daily for 24 weeks) with or without bevacizumab (15 milligrams per kilogram \[mg/kg\] as intravenous \[IV\] infusion every 3 weeks up 24 weeks).

Conditions

Interventions

DRUG

Aromatase Inhibitor

Participants will receive aromatase inhibitor therapy, at a dose per investigator discretion, once daily for 24 weeks.

DRUG

Bevacizumab

Bevacizumab will be administered at a dose of 15 mg/kg as IV infusion every 3 weeks (or 10 mg/kg every other week in participants receiving weekly paclitaxel), for 24 weeks.

DRUG

Epirubicine

Participants will receive epirubicine at a dose of 100 mg/m\^2 as IV infusion every 3 weeks for 12 weeks.

DRUG

5-Fluorouracil (5FU)

Participants will receive 5FU at a dose of 600 mg/m\^2 as IV infusion every 3 weeks for 12 weeks.

DRUG

Cyclophosphamide

Participants will receive cyclophosphamide at a dose of 600 mg/m\^2 as IV infusion every 3 weeks for 12 weeks.

DRUG

Paclitaxel

Participants will receive paclitaxel at a dose of 80 mg/m\^2 as IV infusion every week for 12 weeks.

DRUG

Docetaxel

Participants will receive docetaxel at a dose of 100 mg/m\^2 as IV infusion every 3 weeks for 12 weeks.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-07
Primary Completion
2022-11-09
Completion
2022-11-09

Countries

  • Norway

Study Locations

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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 NCT00773695 on ClinicalTrials.gov