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Trial information
A Study of Pertuzumab in Combination with Herceptin (Trastuzumab) and Docetaxel in Patients With HER2 Positive Metastatic Breast Cancer.
Status: Recruiting
Protocol number: WO20698
Sponsor: Hoffmann-La Roche; Genentech Inc.
Company division: Pharmaceutical
Official Scientific Title: A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of Herceptin + docetaxel + pertuzumab versus Herceptin + docetaxel + placebo in previously untreated HER2-positive metastatic breast cancer
Brief summary: This 2 arm study will compare the efficacy and safety of Herceptin + docetaxel + pertuzumab versus Herceptin + docetaxel + placebo in female patients who have HER2-positive metastatic breast cancer and who have not received chemotherapy or biologic therapy for their metastatic disease. Patients will be randomized to one of 2 treatment arms, to receive a) Herceptin + docetaxel + pertuzumab or b) Herceptin + docetaxel + placebo. Herceptin will be administered as a loading dose of 8mg/kg iv then 6mg kg iv 3-weekly, docetaxel at a dose of 75mg/mò i.v. 3-weekly, and pertuzumab at a loading dose of 840mg iv, then 420mg iv 3-weekly. The anticipated time on study treatment is until disease progression or unmanageable toxicity, and the target sample size is 500+ individuals. Target sample size is 800.
Study phase: III
Study type: Interventional; Treatment; Randomized; Double Blind; Active; Parallel; Safety/Efficacy study
Condition: Breast Cancer
Intervention type: Drug
Intervention name: pertuzumab
Primary outcome: 1. Progression free survival.
Key secondary outcomes: 1. Efficacy: Overall survival, objective response rate. Safety: CHF and asymptomatic LVEF events; LVEF measurements; AEs and lab parameters.
Inclusion criteria: - adult patients, >=18 years of age;
- cancer of the breast, with locally recurrent or metastatic disease;
- HER2 positive (FISH-positive or IHC 3+);
- candidate for chemotherapy;
- ECOG performance status 0 or 1.
Exclusion criteria: - anticancer therapy for metastatic breast cancer (except for one prior hormonal regimen);
- tyrosine kinase/HER inhibitors for breast cancer, except Herceptin used in the neoadjuvant or adjuvant setting;
- systemic breast cancer treatment in neoadjuvant or adjuvant setting, with a disease-free interval from completion of systemic treatment to metastatic diagnosis of <12 months;
- CNS metastases;
- clinically relevant cardiovascular disease.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: February, 2008
Trial registration date: 12/17/2007
Date last updated: 9/29/2008
Link to trial result
This trial is being conducted at the following locations:Argentina - Buenos Aires
- Chaco-Resistencia
- Córdoba
- La Plata
- Mendoza
- Rosario
Brazil - Caxias do Sul
- Fortaleza
- Goiania
- Ijuí
- Jaú
- Porto Alegre
- Ribeirão Preto
- Rio De Janeiro
- Salvador
- Santo Andre
- Santos
- Sao Paulo
- Sorocaba
China - Beijing
- Hong Kong
- Shanghai
- Suzhou
- Wuhan
Costa Rica Finland France - Bayonne
- Bordeaux
- Chaussée Saint Victor
- Dijon
- La Roche Sur Yon
- Le Mans
- Marseille
- Montpellier
- Nice
- Rennes
- Saint Herblain
- Salouel
Germany - Berlin
- Bielefeld
- Essen
- Halle
- Hamburg
- Heidelberg
- Mainz
- München
- Rheinfelden
- Stuttgart
- Trier
- Tübingen
Italy - Antella (Fi)
- Brescia
- Brindisi
- Candiolo
- Chieti
- Frosinone
- Macerata
- Meldola (Fo)
- Prato
- Ravenna
- Roma
Korea, Republic of Mexico Philippines Poland - Lublin
- Poznan
- Szczecin
- Warszawa
Russian Federation - Ivanovo
- Izhevsk
- Kursk
- Moscow
- Omsk
- Orenburg
- St Petersburg
Singapore Spain - Barcelona
- Jaen
- La Coruna
- La Laguna
- Lerida
- Madrid
- Malaga
Thailand United Kingdom - Cambridge
- Chelsmford
- Leicester
- Merseyside
- Northwood
- Truro
- Westcliffe-on-Sea
United States - Scottsdale, AZ
- Jonesboro, AR
- Anaheim, CA
- Bakersfield, CA
- Baldwin Park, CA
- Bellflower, CA
- Beverly Hills, CA
- Campbell, CA
- Concord, CA
- Fontana, CA
- Fountain Valley, CA
- Hayward, CA
- Irvine, CA
- Los Angeles, CA
- Modesto, CA
- Oakland, CA
- Panorama City, CA
- Riverside, CA
- Roseville, CA
- Sacramento, CA
- San Diego , CA
- San Francisco, CA
- San Jose, CA
- Santa Clara, CA
- South San Francisco , CA
- Vallejo, CA
- Walnut Creek, CA
- Woodland Hills, CA
- Washington, DC
- Boca Raton, FL
- Bonita Springs, FL
- Bradenton, FL
- Cape Coral, FL
- Coral Springs, FL
- Englewood, FL
- Fort Myers, FL
- Gainesville, FL
- Hollywood, FL
- Lakeland, FL
- Naples, FL
- Orlando, FL
- Port Charlotte, FL
- Sarasota , FL
- Tampa, FL
- Venice, FL
- Gainesville, GA
- Marietta, GA
- Napersville, IL
- Quincy, IL
- Zion, IL
- Indianapolis , IN
- Munster, IN
- Vincennes, IN
- Iowa City, IA
- Westwood, KS
- Wichita, KS
- Louisville, KY
- Lafayette, LA
- Shreveport, LA
- Bethesda, MD
- Pittsfield, MA
- Free Soil, MI
- Grand Rapids, MI
- Saint Joseph, MI
- Edina, MN
- Minneapolis, MN
- Saint Louis Park, MN
- Lincoln, NE
- Omaha, NE
- Las Vegas, NV
- Lebanon, NH
- Livingston, NJ
- Mountain Lakes, NJ
- Farmington, NM
- Elmhurst, NY
- New York, NY
- Rochester, NY
- Durham, NC
- Hickory , NC
- Huntersville, NC
- Canton, OH
- Cincinnati, OH
- Columbus, OH
- Newark, OH
- Toledo, OH
- Norman, OK
- Oklahoma City, OK
- Tulsa , OK
- Kittanning, PA
- Pittsburgh, PA
- Providence, RI
- Bristol, TN
- Chatanooga, TN
- Chattanooga, TN
- Germantown, TN
- Johnson City, TN
- Knoxville, TN
- Nashville, TN
- Houston, TX
- San Antonio, TX
- Ogden, UT
- Rutland, VT
- Tacoma, WA
- Walla Walla, WA
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