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A Study of Docetaxel Monotherapy or DOXIL®/CAELYX® and Docetaxel in Patients With Advanced Breast Cancer

Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cancer of Breast

Intervention: DOXIL/CAELYX (Drug); Docetaxel (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official(s) and/or principal investigator(s):
Joseph Sparano, MD, Principal Investigator, Affiliation: Montefiore Medical Center,111 East 210th St. Oncology,Bronx, NY

Summary

This study will evaluate the safety and effectiveness of a combination of doxorubicin HCl liposome injection (DOXIL/CAELYX) and docetaxel in women with recurrent advanced breast cancer who received anthracycline in the adjuvant or neoadjuvant setting.

The safety and effectiveness of the combination will be compared to treatment with docetaxel alone (monotherapy). The purpose of this research study is to determine if overall survival for the docetaxel and DOXIL/CAELYX treated group is longer than that for the group treated with docetaxel alone. Additional comparisons between the two treatment groups include: response rate (how much your tumor shrinks in response to the drug), time to progression, safety, and quality of life.

Clinical Details

Official title: A Randomized Controlled Study of Docetaxel Monotherapy or DOXIL®/CAELYX® and Docetaxel for the Treatment of Advanced Breast Cancer

Study design: Treatment

Primary outcome: Overall Survival: The interval between the date of randomization and the subject' death from any cause.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Female

- Age 18 years or older

- Advanced breast cancer (Stage IIIb, not amenable to surgical treatment or Stage IV),

for which there is histologic or cytologic proof of malignancy

Locations and Contacts

Salzburg A-5020, Austria

Wien A-1130, Austria

Stara Zagora 6003, Bulgaria

Plovdiv 4004, Bulgaria

Sofia 1784, Bulgaria

Varna 9010, Bulgaria

Shumen 9700, Bulgaria

Sofia 1756, Bulgaria

Tartu 51003, Estonia

Debrecen H-4032, Hungary

Budapest H-1122, Hungary

Szeged H-6720, Hungary

Budapest H-1145, Hungary

Kistarcsa H-2143, Hungary

Budapest H-1106, Hungary

Szekesfehervar H-8000, Hungary

Zalaegerszeg H-8900, Hungary

Budapest H-1082, Hungary

Budapest H-1135, Hungary

Jerusalem 91031, Israel

Tel-Aviv 64239, Israel

Haifa 31096, Israel

Ramat-Gan 52621, Israel

Torino 10123, Italy

Modena 41100, Italy

Reggio Emillia 42100, Italy

Bologna 40138, Italy

Riga LV-1002, Latvia

Ryga LV-1038, Latvia

Kaunas LT-50010, Lithuania

Kaunas LT-45434, Lithuania

Vilnius LT-08660, Lithuania

Den Haag 2545 CH, Netherlands

Capelle A/D Ijssel 2906 ZC, Netherlands

Roosendaal 4708 AE, Netherlands

Apeldoorn 7334 DZ, Netherlands

Dordrecht 3318 AT, Netherlands

Dirksland 3247 BW, Netherlands

Arnhem 6815 AD, Netherlands

Bialystok 15-027, Poland

Lodz 93-509, Poland

Lublin 25-734, Poland

Styczniowego 81-519, Poland

Kopernika 30 10-513, Poland

Garncarska 11 31-115, Poland

Gdansk 80-210, Poland

Koszalin 75-581, Poland

Poznan 15-027, Poland

Bytom 41-902, Poland

Szaserow 128, Poland

Artwinskiego 3 25-734, Poland

Matosinhos 4454-509, Portugal

Coimbra 3001-651, Portugal

Porto 4200-072, Portugal

Moscow 143423, Russian Federation

St. Petersburg 198255, Russian Federation

Obninsk 249020, Russian Federation

Arkhangelsk 163045, Russian Federation

Yaroslavl 150054, Russian Federation

N.Novgorod 603000, Russian Federation

Kazan 420029, Russian Federation

Moscow 115478, Russian Federation

Izhevsk 426009, Russian Federation

Samara 443066, Russian Federation

Krasnodar 350040, Russian Federation

Balashikha 143900, Russian Federation

Moscow 129128, Russian Federation

St. Petersburg 197758, Russian Federation

Ekaterinburg 620036, Russian Federation

Moscow 129301, Russian Federation

Moscow 105229, Russian Federation

Moscow 105229, Russian Federation

Moscow 125284, Russian Federation

Volgograd 400138, Russian Federation

Moscow 117997, Russian Federation

Moscow 121359, Russian Federation

St. Petersburg 197089, Russian Federation

Saratov 413100, Russian Federation

Stavropol 355047, Russian Federation

Smolensk 214000, Russian Federation

Moscow 125130, Russian Federation

Moscow 111033, Russian Federation

Voronezh 394000, Russian Federation

Barnaul 656049, Russian Federation

Lipetsk 398005, Russian Federation

Tumen 625023, Russian Federation

Ryazan 390011, Russian Federation

Omsk 644013, Russian Federation

Tomsk 634009, Russian Federation

Nizhni Novgorod 603126, Russian Federation

St. Petersburg 191104, Russian Federation

Vladimir 600009, Russian Federation

St. Petersburg 197110, Russian Federation

Irkutsk 664035, Russian Federation

Pyatigorsk 357500, Russian Federation

Ulianovsk 432063, Russian Federation

Rostovna-Donu 344037, Russian Federation

Kazan 420111, Russian Federation

Belgorod 308010, Russian Federation

Cherepovets 162062, Russian Federation

Petrozavodsk 185007, Russian Federation

Ivanovo 153040, Russian Federation

Beograd 11000, Serbia and Montenegro

Nis 18000, Serbia and Montenegro

Saxonwold 2196, South Africa

Parktown 2193, South Africa

Groenkloof 0181, South Africa

Pretoria 0041, South Africa

Port Elizabeth 6001, South Africa

Cape Town 7500, South Africa

Kimberly 8301, South Africa

Rosebank 2196, South Africa

Madrid 28034, Spain

Dnepropetrovsk 49102, Ukraine

Kiev 03115, Ukraine

Odessa 65005, Ukraine

Kiev 03022, Ukraine

Cherkassy 18009, Ukraine

Dnepropetrovsk 49055, Ukraine

Kiev 04070, Ukraine

Kiev 03022, Ukraine

Kiev 03022, Ukraine

Kiev 03022, Ukraine

Dnepropetrovsk 49055, Ukraine

Odessa 65005, Ukraine

Kharkov 61070, Ukraine

Uzhgorod 88014, Ukraine

Lutsk 43018, Ukraine

Chernivtsi 58013, Ukraine

Zhitomir 10002, Ukraine

Kiev 03022, Ukraine

Donetsk 83092, Ukraine

Cherkassy 18009, Ukraine

Kiev 03115, Ukraine

London SW3 6JJ, United Kingdom

Surrey SM2 5PT, United Kingdom

London, United Kingdom

Nottingham NG5 1PB, United Kingdom

Withington M20 4BX, United Kingdom

Huddersfield HD3 3EA, United Kingdom

Alabaster, Alabama 35007, United States

Birmingham, Alabama 35235, United States

Fountain Valley, California 92708, United States

Fresno, California 93710, United States

Gilroy, California 95020, United States

Long Beach, California 90813, United States

Los Angeles, California 90057, United States

Palm Springs, California 92262, United States

Fountain Valley, California, United States

Aurora, Colorado, United States

Fairfield, Connecticut 06824, United States

Newark, Delaware 19718, United States

Washington, District of Columbia, United States

New Port Richey, Florida 34655, United States

Ocala, Florida 34470, United States

Orlando, Florida 32806, United States

Pompano Beach, Florida 33064, United States

Pompano Beach, Florida, United States

Titusville, Florida 32796, United States

Kissimmee, Florida 34741, United States

Fort Lauderdale, Florida 33308, United States

Ormond Beach, Florida, United States

New Port Richey, Florida 34655, United States

Fort Gordon, Georgia 30905, United States

Griffin, Georgia 30224, United States

Centralia, Illinois 62801, United States

Joliet, Illinois 60432, United States

Indianapolis, Indiana 46254, United States

Kansas City, Kansas, United States

Lexington, Kentucky, United States

Alexandra, Louisiana 71301, United States

Lake Charles, Louisiana 70601, United States

Lafayette, Louisiana 70503, United States

Scarborough, Maine 04074, United States

Baltimore, Maryland 21229, United States

Baltimore, Maryland, United States

Lansing, Michigan 48910, United States

Jackson, Mississippi, United States

St. Louis, Missouri 63141, United States

Las Vegas, Nevada, United States

Exeter, New Hampshire, United States

Newark, New Jersey 07103, United States

Voorhees, New Jersey, United States

Albuquerque, New Mexico 87109, United States

Bronx, New York 10467, United States

New York, New York, United States

Cooperstown, New York, United States

Gastonia, North Carolina 28054, United States

Winston-Salem, North Carolina 27103, United States

Wilmington, North Carolina, United States

Youngstown, Ohio, United States

Upland, Pennsylvania 19013, United States

West Reading, Pennsylvania 19611, United States

Philadelphia, Pennsylvania 19146, United States

Cranston, Rhode Island 02920, United States

Providence, Rhode Island 02905, United States

Charleston, South Carolina 29403, United States

Charleston, South Carolina 29406, United States

Fort Worth, Texas 76104, United States

Laredo, Texas 78041, United States

Pasadena, Texas 77504, United States

Glendale, Wisconsin 53212, United States

West Bend, Wisconsin, United States

Additional Information

Starting date: September 2004
Last updated: March 5, 2007

Page last updated: June 20, 2008

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