A Study of Docetaxel Monotherapy or DOXIL and Docetaxel in Patients With Advanced Breast Cancer
A Randomized Controlled Study of Docetaxel Monotherapy or Docetaxel and DOXIL for the Treatment of Advanced Breast Cancer
2 other identifiers
interventional
751
17 countries
146
Brief Summary
The purpose of the study is to evaluate whether the time to progression for the DOXIL and docetaxel combination therapy group was superior to that of the group treated with docetaxel monotherapy in participants with advanced breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Sep 2004
146 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 8, 2004
CompletedFirst Posted
Study publicly available on registry
September 13, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedResults Posted
Study results publicly available
October 2, 2012
CompletedApril 21, 2014
April 1, 2014
4.3 years
September 8, 2004
December 15, 2009
April 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Progression
Time interval in months between the date of randomization and the date of disease progression or death due to progression, whichever occurred first.
From date of randomization until date of disease progression or death, whichever occurred first, until approximately 485 events of disease progression or death were observed, as assessed approximately 15 months after the last patient was enrolled
Secondary Outcomes (2)
Overall Survival
From the date of randomization until the participant's death from any cause, as assessed until approximately 485 death events were observed which is assessed approximately 25 months after the last patient was enrolled
Response Rate: Number of Participants in the Evaluable Population Who Achieved a Complete Response (CR) or Partial Response (PR)
Up to 30 to 42 days after last dose of study medication
Study Arms (2)
DOXIL and docetaxel combination therapy
EXPERIMENTALDOXIL and docetaxel combination therapy: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
Docetaxel monotherapy
ACTIVE COMPARATORDocetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle
Interventions
Docetaxel monotherapy: docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle. DOXIL in combination with docetaxel: docetaxel 60 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle
DOXIL 30 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
Eligibility Criteria
You may qualify if:
- Females with locally advanced or metastatic breast cancer who received prior anthracycline therapy in the neoadjuvant or adjuvant setting, and had at least a 12-month disease-free interval since the end of their last cytotoxic therapy, were eligible for the study
- Participants who received prior hormonal therapy, or no more than 1 cytotoxic chemotherapy regimen (anthracyclines, taxanes, or antitubulin agents were not permitted), or both for advanced disease
- Participants with normal cardiac function, as evidenced by a normal left ventricular ejection fraction
You may not qualify if:
- More than 1 prior cytotoxic chemotherapy regimen for advanced breast cancer
- Treatment of advanced breast cancer with an anthracycline, paclitaxel, docetaxel, vinorelbine, or vinblastine (prior treatment of advanced breast cancer with 1 regimen that included alkylating agents or antimetabolite agents was acceptable)
- Less than 2 months since the last dose of trastuzumab
- Less than 3 weeks since last dose of tamoxifen or fulvestrant, or less than 1 week since the last dose of other hormonal therapy
- Radiation to areas of disease within 30 days before study enrollment
- History of New York Heart Association Class II or greater cardiac disease or other clinical evidence of congestive heart failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (147)
Unknown Facility
Hoover, Alabama, United States
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Fountain Valley, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Palm Springs, California, United States
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Newark, Delaware, United States
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Lakeland, Florida, United States
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Fort Gordon, Georgia, United States
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Centralia, Illinois, United States
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Joliet, Illinois, United States
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Indianapolis, Indiana, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Lafayette, Louisiana, United States
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Baltimore, Maryland, United States
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Jackson, Mississippi, United States
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Las Vegas, Nevada, United States
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Newark, New Jersey, United States
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Albuquerque, New Mexico, United States
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Cooperstown, New York, United States
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New York, New York, United States
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The Bronx, New York, United States
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Gastonia, North Carolina, United States
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Philadelphia, Pennsylvania, United States
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Upland, Pennsylvania, United States
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Providence, Rhode Island, United States
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Charleston, South Carolina, United States
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North Charleston, South Carolina, United States
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Fort Worth, Texas, United States
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Pasadena, Texas, United States
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Plovdiv, Bulgaria
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Shumen, Bulgaria
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Sofia, Bulgaria
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Stara Zagora, Bulgaria
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Varna, Bulgaria
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Tartu, Estonia
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Rabat-les-Trois-Seigneurs, France
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Tunis, France
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Budapest, Hungary
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Debrecen, Hungary
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Szeged, Hungary
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Székesfehérvár, Hungary
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Zalaegerszeg, Hungary
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Ashkelon, Israel
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Haifa, Israel
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Jerusalem, Israel
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Ramat Gan, Israel
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Tel Aviv, Israel
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Riga, Latvia
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Kaunas, Lithuania
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Vilnius, Lithuania
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Arnhem, Netherlands
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Capelle aan den IJssel, Netherlands
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Roosendaal, Netherlands
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The Hague, Netherlands
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Bialystok, Poland
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Bydgoszcz, Poland
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Bytom, Poland
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Gdansk, Poland
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Gdynia, Poland
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Gliwice, Poland
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Kielce, Poland
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Koszalin, Poland
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Krakow, Poland
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Lodz, Poland
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Lublin, Poland
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Olsztyn, Poland
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Poznan, Poland
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Warsaw, Poland
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Coimbra, Portugal
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Matosinhos Municipality, Portugal
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Bacau, Romania
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Bucharest, Romania
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Cluj-Napoca, Romania
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Hunedoara, Romania
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Iași, Romania
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Onești, Romania
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Timișoara, Romania
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Arkhangelsk, Russia
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Balashikha, Russia
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Barnaul, Russia
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Chelyabinsk, Russia
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Engels Saratov Region, Russia
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Irkutsk, Russia
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Ivanovo, Russia
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Izhevsk, Russia
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Kazan', Russia
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Krasnodar, Russia
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Leningrad Region, Russia
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Lipetsk, Russia
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Moscow, Russia
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Moscow Region, Russia
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Murmansk, Russia
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Nizhny Novgorod, Russia
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Novosibirsk, Russia
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Obninsk, Russia
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Omsk, Russia
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Oryol, Russia
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Petrozavodsk, Russia
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Pyatigorsk, Russia
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Rostov-on-Don, Russia
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Ryazan, Russia
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Saint Petersburg, Russia
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Samara, Russia
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Smolensk, Russia
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Stavropol, Russia
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Tomsk, Russia
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Tver', Russia
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Ulyanovsk, Russia
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Vladimir, Russia
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Volgograd, Russia
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Voronezh, Russia
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Yaroslavl, Russia
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Yekaterinburg, Russia
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Belgrade, Serbia
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Kamenitz, Serbia
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Niš, Serbia
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Cape Town, South Africa
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Johannesburg, South Africa
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Kimberley, South Africa
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Parktown, South Africa
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Port Elizabeth, South Africa
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Pretoria, South Africa
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Pretoria Gauteng, South Africa
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Bilbao Vizcaya, Spain
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Lleida, Spain
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Madrid, Spain
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Santander, Spain
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Seville, Spain
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Cherkassy, Ukraine
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Chernivtsi, Ukraine
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Dnipro, Ukraine
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Donetsk, Ukraine
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Kharkiv, Ukraine
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Kiev, Ukraine
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Luhansk, Ukraine
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Lutsk, Ukraine
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Odesa, Ukraine
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Poltava, Ukraine
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Simferopol, Ukraine
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Uzhhorod, Ukraine
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Vinnitsa, Ukraine
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Zhytomyr, Ukraine
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Huddersfield, United Kingdom
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Manchester, United Kingdom
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Nottingham, United Kingdom
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Sutton, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director Medical Leader
- Organization
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2004
First Posted
September 13, 2004
Study Start
September 1, 2004
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
April 21, 2014
Results First Posted
October 2, 2012
Record last verified: 2014-04