OncRef

Clinical Trial: NCT00773695

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

Status:

COMPLETED

Phase:

Phase 2

Lead Sponsor:Hoffmann-La Roche
Information Provided By:Hoffmann-La Roche
Last Update Posted:2023-01-09

Study Overview

Brief 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).

Official Title

A Multicenter, Randomized, Phase II Clinical Trial to Evaluate the Effect of Avastin in Combination With Neoadjuvant Treatment Regimens on the Molecular and Metabolic Characteristics and Changes in the Primary Tumors With Reference to the Obtained Responses in Patients With Large Primary HER2 Negative Breast Cancers

Conditions

Breast Cancer

Intervention / Treatment

  • Drug: Aromatase Inhibitor
  • Drug: Bevacizumab
  • Drug: Epirubicine
  • Drug: 5-Fluorouracil (5FU)
  • Drug: Cyclophosphamide
  • Drug: Paclitaxel
  • Drug: Docetaxel

Other Study ID Numbers

  • ML21744

Start Date (Actual)

2008-11-07

Primary Completion Date (Actual)

2022-11-09

Study Completion Date (Actual)

2022-11-09

Enrollment (Actual)

150

Study Type

Interventional

Phase

Phase 2