Clinical trial NCT00091442: A Study of Docetaxel Monotherapy or DOXIL and Docetaxel in Patients With Advanced Breast Cancer
Official title: A Randomized Controlled Study of Docetaxel Monotherapy or Docetaxel and DOXIL for the Treatment of Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Breast Cancer
Advanced breast cancer
Breast Tumors
Cancer of Breast
Human Mammary Carcinoma
Mammary Neoplasms, Human
DOXIL
Docetaxel
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2004-09-13
Enrollment: 751
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This is a randomized (the study medication is assigned by a random order), active control (study medication will be compared with available standard care of treatment), parallel-group (each treatment group will be treated simultaneously at the same time and each participant only receives one treatment regimen as assigned), open-label (both the investigator and the participant know the intervention received by the participant), multicenter study designed to determine if women with locally advanced or metastatic breast cancer, who were previously treated with prior anthracycline therapy in the neoadjuvant (administration of treatment before surgery) or adjuvant setting (administration of treatment after surgery), and who also had a disease-free interval of at least 12 months since the end of their last cytotoxic therapy, would benefit from the addition of DOXIL to docetaxel therapy. Approximately 751 participants will be randomly assigned to either receive docetaxel monotherapy or DOXIL in combination with docetaxel therapy. Treatment is to continue until disease progression or the occurrence of unacceptable treatment related toxicity. Safety evaluations will include assessments of adverse events which will be recorded from the first study related procedure until 30 days after the last dose of medication; clinical laboratory tests and tests for cardiac function (multiple gated acquisition scan/echocardiogram and electrocardiogram) which will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Time to Progression
timeFrame: 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:
measure: Overall Survival
timeFrame: 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
measure: Response Rate: Number of Participants in the Evaluable Population Who Achieved a Complete Response (CR) or Partial Response (PR)
timeFrame: Up to 30 to 42 days after last dose of study medication
Other outcomes:
Locations:
city: Hoover
country: United States
state: Alabama
city: Fountain Valley
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Palm Springs
country: United States
state: California
city: Newark
country: United States
state: Delaware
city: Lakeland
country: United States
state: Florida
city: Fort Gordon
country: United States
state: Georgia
city: Centralia
country: United States
state: Illinois
city: Joliet
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Lafayette
country: United States
state: Louisiana
city: Baltimore
country: United States
state: Maryland
city: Jackson
country: United States
state: Mississippi
city: Las Vegas
country: United States
state: Nevada
city: Newark
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Bronx
country: United States
state: New York
city: Cooperstown
country: United States
state: New York
city: New York
country: United States
state: New York
city: Gastonia
country: United States
state: North Carolina
city: Philadelphia
country: United States
state: Pennsylvania
city: Upland
country: United States
state: Pennsylvania
city: Providence
country: United States
state: Rhode Island
city: Charleston
country: United States
state: South Carolina
city: N Charleston
country: United States
state: South Carolina
city: Fort Worth
country: United States
state: Texas
city: Pasadena
country: United States
state: Texas
city: Plovdiv
country: Bulgaria
city: Shumen
country: Bulgaria
city: Sofia
country: Bulgaria
city: Stara Zagora
country: Bulgaria
city: Varna
country: Bulgaria
city: Tartu N/A
country: Estonia
city: Rabat
country: France
city: Tunis
country: France
city: Budapest N/A
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Szeged
country: Hungary
city: Szekesfehervar
country: Hungary
city: Zalaegerszeg
country: Hungary
city: Ashkelon
country: Israel
city: Haifa
country: Israel
city: Jerusalem
country: Israel
city: Ramat-Gan
country: Israel
city: Tel Aviv
country: Israel
city: Riga
country: Latvia
city: Kaunas
country: Lithuania
city: Vilnius
country: Lithuania
city: Arnhem
country: Netherlands
city: Capelle Aan Den Ijssel
country: Netherlands
city: Den Haag
country: Netherlands
city: Roosendaal
country: Netherlands
city: Bialystok
country: Poland
city: Bydgoszcz
country: Poland
city: Bytom
country: Poland
city: Gdansk
country: Poland
city: Gdynia N/A
country: Poland
city: Gliwice
country: Poland
city: Kielce
country: Poland
city: Koszalin
country: Poland
city: Krakow
country: Poland
city: Lodz
country: Poland
city: Lublin
country: Poland
city: Olsztyn
country: Poland
city: Poznan
country: Poland
city: Warsaw
country: Poland
city: Coimbra
country: Portugal
city: Matosinhos N/A
country: Portugal
city: Bacau
country: Romania
city: Bucuresti
country: Romania
city: Cluj-Napoca
country: Romania
city: Hunedoara
country: Romania
city: Iasi
country: Romania
city: Onesti
country: Romania
city: Timisoara
country: Romania
city: Arkhangelsk
country: Russian Federation
city: Balashikha
country: Russian Federation
city: Barnaul
country: Russian Federation
city: Chelyabinsk
country: Russian Federation
city: Ekaterinburg
country: Russian Federation
city: Engels Saratov Region
country: Russian Federation
city: Irkutsk
country: Russian Federation
city: Ivanovo
country: Russian Federation
city: Izhevsk
country: Russian Federation
city: Kazan
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Leningrad Region
country: Russian Federation
city: Lipetsk
country: Russian Federation
city: Moscow N/A
country: Russian Federation
city: Moscow Region
country: Russian Federation
city: Moscow
country: Russian Federation
city: Murmansk
country: Russian Federation
city: N Novgorod N/A
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Obninsk
country: Russian Federation
city: Omsk
country: Russian Federation
city: Orel
country: Russian Federation
city: Petrozavodsk
country: Russian Federation
city: Pyatigorsk
country: Russian Federation
city: Rostov-Na-Donu
country: Russian Federation
city: Ryazan
country: Russian Federation
city: Samara N/A
country: Russian Federation
city: Smolensk
country: Russian Federation
city: St Petersburg N/A
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Stavropol
country: Russian Federation
city: Tomsk
country: Russian Federation
city: Tver
country: Russian Federation
city: Ulianovsk
country: Russian Federation
city: Vladimir
country: Russian Federation
city: Volgograd
country: Russian Federation
city: Voronezh
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Beograd
country: Serbia
city: Nis
country: Serbia
city: Sremska Kamenica
country: Serbia
city: Cape Town
country: South Africa
city: Johannesburg
country: South Africa
city: Kimberley
country: South Africa
city: Parktown
country: South Africa
city: Port Elizabeth
country: South Africa
city: Pretoria Gauteng
country: South Africa
city: Pretoria
country: South Africa
city: Bilbao Vizcaya
country: Spain
city: Lérida
country: Spain
city: Madrid
country: Spain
city: Santander N/A
country: Spain
city: Sevilla
country: Spain
city: Cherkassy
country: Ukraine
city: Chernivtsi
country: Ukraine
city: Dnepropetrovsk
country: Ukraine
city: Donetsk
country: Ukraine
city: Kharkov
country: Ukraine
city: Kiev
country: Ukraine
city: Lugansk
country: Ukraine
city: Lutsk
country: Ukraine
city: Odessa
country: Ukraine
city: Poltava
country: Ukraine
city: Simferopol
country: Ukraine
city: Uzhgorod
country: Ukraine
city: Vinnitsa
country: Ukraine
city: Zhitomir
country: Ukraine
city: Huddersfield
country: United Kingdom
city: Manchester
country: United Kingdom
city: Nottingham
country: United Kingdom
city: Sutton
country: United Kingdom
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References: