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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00091442
First received: September 8, 2004
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Docetaxel
Drug: DOXIL
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of Docetaxel Monotherapy or Docetaxel and DOXIL for the Treatment of Advanced Breast Cancer

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Time to Progression [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Time interval in months between the date of randomization and the date of disease progression or death due to progression, whichever occurred first.


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: 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 ] [ Designated as safety issue: No ]
    Time interval in months between the date of randomization and the participant's death from any cause.

  • Response Rate: Number of Participants in the Evaluable Population Who Achieved a Complete Response (CR) or Partial Response (PR) [ Time Frame: Up to 30 to 42 days after last dose of study medication ] [ Designated as safety issue: No ]
    Number of participants in the evaluable population who achieved a CR or PR as per Response Evaluation Criteria In Solid Tumors (RECIST) criteria. CR: Disappearance of all target lesions and PR: at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. Response was assessed by Computed Tomography (CT)/Magnetic Resonance Imaging (MRI).


Enrollment: 751
Study Start Date: September 2004
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: DOXIL and docetaxel combination therapy
DOXIL 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.
Drug: Docetaxel
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
Other Name: Docetaxel
Drug: DOXIL
DOXIL 30 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
Other Name: DOXIL in combination with Docataxel
Active Comparator: Docetaxel monotherapy
Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle
Drug: Docetaxel
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
Other Name: Docetaxel

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00091442

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

No publications provided

Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00091442     History of Changes
Obsolete Identifiers: NCT00343538
Other Study ID Numbers: CR004120, DOXILBCA3001
Study First Received: September 8, 2004
Results First Received: December 15, 2009
Last Updated: April 2, 2014
Health Authority: United States: Food and Drug Administration
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Breast Cancer
Advanced breast cancer
Breast Tumors
Cancer of Breast
Human Mammary Carcinoma
Mammary Neoplasms, Human
DOXIL
Docetaxel

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Doxorubicin
Docetaxel
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014