Trial information

A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab)/Docetaxel in Patients With HER2 Positive Metastatic Breast Cancer.

Status: Recruiting

Protocol number: BO20231

Sponsor: Hoffmann-La Roche

Company division: Pharmaceutical

Official Scientific Title: A randomized, open-label study to compare the effect of first-line treatment with Avastin in combination with Herceptin/docetaxel and Herceptin/docetaxel alone on progression-free survival in patients with HER2 positive locally recurrent or metastatic breast cancer.

Brief summary: This 2 arm study will compare the efficacy and safety of Avastin plus Herceptin/docetaxel, versus Herceptin/docetaxel alone, in patients with HER2 positive locally recurrent or metastatic breast cancer who have not received prior chemotherapy for their metastatic disease. Patients will be randomized 1:1 to receive either Avastin (15mg/kg iv q3weeks) + Herceptin (8mg/kg iv loading dose and 6mg/kg iv q3weeks maintenance) + docetaxel (100mg/m2 iv q3weeks) or Herceptin + docetaxel alone. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals. Target sample size is 410.

Study phase: III

Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study

Condition: Breast Cancer

Intervention type: Drug

Intervention name: bevacizumab [Avastin]

Primary outcome: 1. Progression-free survival Time frame: Event driven

Key secondary outcomes: 1. Overall survival Time frame: (36 months after randomization of last patient) 2. Best overall response, duration of response, time to treatment failure. Time frame: Event driven 3. QoL, AEs, targeted events including CHF, laboratory parameters. Time frame: Throughout study

Inclusion criteria:

• adult patients, >=18 years of age;
• HER2 positive breast cancer with locally recurrent or metastatic lesions;
• eligible for chemotherapy;
• baseline LVEF >=50%.

Exclusion criteria:

• previous chemotherapy for metastatic or locally recurrent breast cancer;
• previous radiotherapy for metastatic breast cancer (except for metastatic bone pain relief);
• other primary tumor within last 5 years, with the exception of basal or squamous skin cancer, or in situ cancer of the cervix;
• clinically significant cardiovascular disease;
• chronic daily treatment with aspirin (>325mg/day) or clopidogrel (>75mg/day).

Gender: Males or Females

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

Accepts healthy volunteers: No

Anticipated start date: September, 2006

Trial registration date: 09/18/2006

Date last updated: 11/21/2008

Link to trial result

This trial is being conducted at the following locations:

Argentina

• Buenos Aires
• Cordoba
• La Plata
• Mar Del Plata
• Mendoza
• Salta
• San Martin
• Santa Fe

Australia

• Lismore
• Perth
• Port Macquarie
• Sydney
• Waratah
• Wollongong

Austria

• Graz
• Salzburg
• Vöcklabruck
• Wien

Bosnia and Herzegovina

• Banja Luka
• Tuzla

Brazil

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

Canada

• Calgary, AB
• Halifax, NS
• Sudbury, ON
• Toronto, ON
• Montreal, QC
• Quebec City, QC

Czech Republic

• Praha

France

• Avignon
• Besancon
• Bordeaux
• Clermont-Ferrand
• Lille
• Montpellier
• Villejuif

Italy

• Milano
• Parma
• Udine

Mexico

• Acapulco
• Monterrey
• Torreon

Romania

• Bucharest
• Cluj-Napoca

Russian Federation

• Kazan
• Moscow
• Obninsk
• Ryazan
• St Petersburg
• Ufa

Spain

• Barcelona
• Madrid
• Zaragoza

Turkey

• Ankara
• Izmir

United Kingdom

• Bristol
• Denbigh
• Exeter
• London
• Manchester
• Nottingham
• Preston
• Stoke-on-Trent

Uruguay

• Montevideo