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

April 2, 2014 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

A Randomized Controlled Study of Docetaxel Monotherapy or Docetaxel and DOXIL for the Treatment of Advanced Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

751

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • 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
  • United States
    • Alabama
      • Hoover, Alabama, United States
    • California
      • Fountain Valley, California, United States
      • Long Beach, California, United States
      • Los Angeles, California, United States
      • Palm Springs, California, United States
    • Delaware
      • Newark, Delaware, United States
    • Florida
      • Lakeland, Florida, United States
    • Georgia
      • Fort Gordon, Georgia, United States
    • Illinois
      • Centralia, Illinois, United States
      • Joliet, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Kentucky
      • Lexington, Kentucky, United States
      • Louisville, Kentucky, United States
    • Louisiana
      • Lafayette, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Mississippi
      • Jackson, Mississippi, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Jersey
      • Newark, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Bronx, New York, United States
      • Cooperstown, New York, United States
      • New York, New York, United States
    • North Carolina
      • Gastonia, North Carolina, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
      • Upland, Pennsylvania, United States
    • Rhode Island
      • Providence, Rhode Island, United States
    • South Carolina
      • Charleston, South Carolina, United States
      • N Charleston, South Carolina, United States
    • Texas
      • Fort Worth, Texas, United States
      • Pasadena, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: DOXIL
DOXIL 30 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
Other Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time interval in months between the date of randomization and the participant's death from any cause.
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)
Time Frame: Up to 30 to 42 days after last dose of study medication
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).
Up to 30 to 42 days after last dose of study medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

December 1, 2008

Study Registration Dates

First Submitted

September 8, 2004

First Submitted That Met QC Criteria

September 10, 2004

First Posted (ESTIMATE)

September 13, 2004

Study Record Updates

Last Update Posted (ESTIMATE)

April 21, 2014

Last Update Submitted That Met QC Criteria

April 2, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR004120
  • DOXILBCA3001 (OTHER: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Docetaxel

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in New Zealand

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe