Trial information

A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer.

Status: Recruiting

Protocol number: WO20697

Sponsor: Hoffmann-La Roche

Company division: Pharmaceutical

Official Scientific Title: A randomized, open label study to compare the complete pathological response rate achieved with Herceptin plus docetaxel, versus Herceptin plus docetaxel plus pertuzumab, versus Herceptin plus pertuzumab, versus pertuzumab and docetaxel in patients with locally advanced, inflammatory or early stage

Brief summary: This 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatment regimens in female patients with locally advanced, inflammatory or early stage HER2 positive breast cancer. Before surgery, patients will be randomized to one of 4 treatment arms, to receive 4 cycles of a)Herceptin + docetaxel b)Herceptin + docetaxel + pertuzumab c)Herceptin + pertuzumab or 4)pertuzumab + docetaxel. Pertuzumab will be administered at a loading dose of 840mg iv, then 420mg iv 3-weekly, Herceptin at a loading dose of 8mg/kg iv then 6mg/kg 3-weekly, and docetaxel at a dose of 75mg/m2 escalating to 100mg/m2 3-weekly. During the entire pre- and post-surgery period all patients will receive adequate chemotherapy as per standard of care, as well as any surgery and/or radiotherapy as required. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 400.

Study phase: II

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

Condition: Breast Cancer

Intervention type: Drug

Intervention name: pertuzumab

Primary outcome: 1. Pathological complete response rate Time frame: Post-surgery

Key secondary outcomes: 1. Disease-free interval, PFS, breast-conserving surgery rate. Time frame: Event driven 2. AEs, laboratory parameters, LVEF Time frame: Throughout study

Inclusion criteria:

• female patients, >=18 years of age;
• locally advanced, inflammatory or early stage invasive breast cancer;
• HER2 positive (HER2+++ by IHC or FISH/CISH+).

Exclusion criteria:

• metastatic disease (Stage IV) or bilateral breast cancer;
• previous anticancer therapy or radiotherapy for any malignancy;
• other malignancy, other than cancer in situ of the cervix, or basal cell cancer;
• insulin-dependent diabetes;
• clinically relevant cardiovascular disease.

Gender: Females

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

Accepts healthy volunteers: No

Anticipated start date: December, 2007

Trial registration date: 10/15/2007

Date last updated: 11/21/2008

Link to trial result

This trial is being conducted at the following locations:

Australia

• Geelong
• Perth

Austria

• Wien

Brazil

• Ijuí
• Itajaí
• Jaú
• Porto Alegre
• Santo Andre
• Sao Paulo
• Sorocaba

Canada

• Moncton, NB
• Kingston, ON
• Toronto, ON
• Montreal, QC
• Quebec City, QC

Israel

• Jerusalem
• Kfar Saba
• Ramat Gan
• Tel Aviv

Italy

• Bologna
• Legnano
• Milano
• Noale
• Parma
• Thiene
• Udine
• Verona
• Vicenza

Korea, Republic of

• Seoul

Mexico

• Aguascalientes
• Hermosillo Sonora
• Puebla

Peru

• Arequipa
• Lima

Poland

• Lublin
• Olsztyn
• Poznan
• Warszawa

Russian Federation

• Kazan
• Moscow
• Petrozavodsk
• Pyatigorsk
• Ryazan
• Samara
• Soshi
• St Petersburg
• Ulyanovsk

Spain

• Barakaldo
• Córdoba
• Madrid
• Sabadell
• Valencia
• Zaragoza

Sweden

• Stockholm
• Uppsala

Switzerland

• Baden
• Zuerich

Taiwan

• Taipei

Thailand

• Bangkok
• Songkhla

Turkey

• Ankara
• Izmir

United Kingdom

• Birmingham
• Manchester