Trial information

A Study of Avastin (Bevacizumab) in Women With HER2 Negative Metastatic Breast Cancer

Status: No longer recruiting

Protocol number: BO17708

Sponsor: Hoffmann-La Roche

Company division: Pharmaceutical

Official Scientific Title: A randomized, double-blind study of the effect of first line treatment with Avastin (bevacizumab) in combination with docetaxel on progression-free survival and disease response in patients with HER2 negative metastatic breast cancer

Brief summary: This study will evaluate the efficacy and safety of 2 doses of Avastin in combination with docetaxel, versus docetaxel plus placebo, in patients with metastatic HER2 negative breast cancer who are candidates for taxane-based chemotherapy but who have not received prior chemotherapy for metastatic disease. The anticipated time on treatment is 1-2 years and the target sample size is 500+ individuals. Target sample size is 705.

Study phase: III

Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study

Condition: Breast Cancer

Intervention type: Drug

Intervention name: bevacizumab [Avastin]

Primary outcome: Progression-free survival. Timeframe: Event driven.

Key secondary outcomes: Best overall response; duration of response; time to treatment failure, overall survival. Timeframe: Event driven. AEs, laboratory parameters, FACT-B QoL instrument, medical resource utilization. TImeframe: Throughout study.

Inclusion criteria:

• female patients >= 18 years of age;
• HER2 negative cancer of the breast with locally recurrent or metastatic disease, suitable for chemotherapy;
• no adjuvant chemotherapy within 6 months before randomization, and no taxane-based chemotherapy within 12 months before randomization;
• ECOG performance status 0-1.

Exclusion criteria:

• previous chemotherapy for metastatic or locally recurrent breast cancer;
• radiotherapy for treatment of metastatic disease;
• other primary tumors within last 5 years, except for controlled limited basal cell or squamous cancer of the skin, or cancer in situ of the cervix;
• spinal cord compression or brain metastases;
• major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization;
• inadequate bone marrow, liver or renal function;
• uncontrolled hypertension.

Gender: Females

Age limits: Min: 18 Years Max: N/A (No limit)

Accepts healthy volunteers: No

Anticipated start date: March, 2006

Trial registration date: 03/10/2006

Date last updated: 9/29/2008

Link to trial result

This trial was conducted at the following locations:

Australia

• Adelaide
• Brisbane
• Fitzroy
• Melbourne
• Perth
• Sydney

Austria

• Graz
• Salzburg
• Vöcklabruck
• Wien

Belgium

• Bruxelles
• Wilrijk

Brazil

• Barretos
• Belo Horizonte
• Florianopolis
• Goiania
• Porto Alegre
• Sao Paulo

Canada

• Calgary, AB
• Edmonton, AB
• Vancouver, BC
• Halifax, NS
• Ottawa, ON
• Sudbury, ON
• Toronto, ON
• Montreal, QC
• Quebec City, QC

China

• Beijing

France

• Besancon
• Bordeaux
• Caen
• Clermont-Ferrand
• Dijon
• Lille
• Montpellier
• Villejuif

Germany

• Berlin
• Erlangen
• Frankfurt Am Main
• Halle
• Hamburg
• Heidelberg
• Jena
• Lemgo
• München
• Stuttgart
• Trier
• Tübingen
• Ulm

Italy

• Biella
• Bologna
• Macerata
• Modena
• Parma
• Taormina
• Treviglio
• Trieste
• Udine

Korea, Republic of

• Seoul

Lithuania

• Kaunas
• Vilnius

Mexico

• Merida
• Mexico City
• Monterrey
• Obregon
• Puebla

Netherlands

• Utrecht

Panama

• Panama City

Poland

• Krakow
• Olsztyn
• Poznan
• Warszawa

Portugal

• Coimbra
• Lisboa

Romania

• Bucharest

South Africa

• Pretoria
• Sandton

Spain

• Barcelona
• Jaen
• Madrid
• Malaga

Sweden

• Linkoeping
• Lund

Switzerland

• Chur

Taiwan

• Kaohsiung
• Taipei

Thailand

• Bangkok

United Kingdom

• Bournemouth
• Cambridge
• Edinburgh
• Leeds
• London
• Manchester
• Middlesex
• Newcastle upon Tyne
• Truro