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AzTrials

Breast CancerPhase 3NCT00091442

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

A Phase 3 study testing Docetaxel and DOXIL in people with Breast Cancer, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 147 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Docetaxel and DOXIL
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
751 participants
Where
147 sitesin 18 countries
Study dates
Sep 2004to Dec 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

147 sites in 18 countries.

147 sites in 18 countries

Russia36 sites

  • Study site

    Arkhangelsk

  • Study site

    Balashikha

  • Study site

    Barnaul

  • Study site

    Chelyabinsk

  • Study site

    Engels Saratov Region

  • Study site

    Irkutsk

  • Study site

    Ivanovo

  • Study site

    Izhevsk

  • Study site

    Kazan'

  • Study site

    Krasnodar

  • Study site

    Leningrad Region

  • Study site

    Lipetsk

  • Study site

    Moscow

  • Study site

    Moscow Region

  • Study site

    Murmansk

  • Study site

    Nizhny Novgorod

  • Study site

    Novosibirsk

  • Study site

    Obninsk

  • Study site

    Omsk

  • Study site

    Oryol

  • Study site

    Petrozavodsk

  • Study site

    Pyatigorsk

  • Study site

    Rostov-on-Don

  • Study site

    Ryazan

  • Study site

    Saint Petersburg

  • Study site

    Samara

  • Study site

    Smolensk

  • Study site

    Stavropol

  • Study site

    Tomsk

  • Study site

    Tver'

  • Study site

    Ulyanovsk

  • Study site

    Vladimir

  • Study site

    Volgograd

  • Study site

    Voronezh

  • Study site

    Yaroslavl

  • Study site

    Yekaterinburg

Other trials in Russia

United States30 sites

  • Study site

    Albuquerque, New Mexico

  • Study site

    Baltimore, Maryland

  • Study site

    Centralia, Illinois

  • Study site

    Charleston, South Carolina

  • Study site

    Cooperstown, New York

  • Study site

    Fort Gordon, Georgia

  • Study site

    Fort Worth, Texas

  • Study site

    Fountain Valley, California

  • Study site

    Gastonia, North Carolina

  • Study site

    Hoover, Alabama

  • Study site

    Indianapolis, Indiana

  • Study site

    Jackson, Mississippi

  • Study site

    Joliet, Illinois

  • Study site

    Lafayette, Louisiana

  • Study site

    Lakeland, Florida

  • Study site

    Las Vegas, Nevada

  • Study site

    Lexington, Kentucky

  • Study site

    Long Beach, California

  • Study site

    Los Angeles, California

  • Study site

    Louisville, Kentucky

  • Study site

    New York, New York

  • Study site

    Newark, Delaware

  • Study site

    Newark, New Jersey

  • Study site

    North Charleston, South Carolina

  • Study site

    Palm Springs, California

  • Study site

    Pasadena, Texas

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Providence, Rhode Island

  • Study site

    The Bronx, New York

  • Study site

    Upland, Pennsylvania

Other trials in United States

Poland14 sites

  • Study site

    Bialystok

  • Study site

    Bydgoszcz

  • Study site

    Bytom

  • Study site

    Gdansk

  • Study site

    Gdynia

  • Study site

    Gliwice

  • Study site

    Kielce

  • Study site

    Koszalin

  • Study site

    Krakow

  • Study site

    Lodz

  • Study site

    Lublin

  • Study site

    Olsztyn

  • Study site

    Poznan

  • Study site

    Warsaw

Other trials in Poland

Ukraine14 sites

  • Study site

    Cherkassy

  • Study site

    Chernivtsi

  • Study site

    Dnipro

  • Study site

    Donetsk

  • Study site

    Kharkiv

  • Study site

    Kiev

  • Study site

    Luhansk

  • Study site

    Lutsk

  • Study site

    Odesa

  • Study site

    Poltava

  • Study site

    Simferopol

  • Study site

    Uzhhorod

  • Study site

    Vinnitsa

  • Study site

    Zhytomyr

Other trials in Ukraine

Romania7 sites

  • Study site

    Bacau

  • Study site

    Bucharest

  • Study site

    Cluj-Napoca

  • Study site

    Hunedoara

  • Study site

    Iași

  • Study site

    Onești

  • Study site

    Timișoara

Other trials in Romania

South Africa7 sites

  • Study site

    Cape Town

  • Study site

    Johannesburg

  • Study site

    Kimberley

  • Study site

    Parktown

  • Study site

    Port Elizabeth

  • Study site

    Pretoria

  • Study site

    Pretoria Gauteng

Other trials in South Africa

Bulgaria5 sites

  • Study site

    Plovdiv

  • Study site

    Shumen

  • Study site

    Sofia

  • Study site

    Stara Zagora

  • Study site

    Varna

Other trials in Bulgaria

Hungary5 sites

  • Study site

    Budapest

  • Study site

    Debrecen

  • Study site

    Szeged

  • Study site

    Székesfehérvár

  • Study site

    Zalaegerszeg

Other trials in Hungary

Israel5 sites

  • Study site

    Ashkelon

  • Study site

    Haifa

  • Study site

    Jerusalem

  • Study site

    Ramat Gan

  • Study site

    Tel Aviv

Other trials in Israel

Spain5 sites

  • Study site

    Bilbao Vizcaya

  • Study site

    Lleida

  • Study site

    Madrid

  • Study site

    Santander

  • Study site

    Seville

Other trials in Spain

Netherlands4 sites

  • Study site

    Arnhem

  • Study site

    Capelle aan den IJssel

  • Study site

    Roosendaal

  • Study site

    The Hague

Other trials in Netherlands

United Kingdom4 sites

  • Study site

    Huddersfield

  • Study site

    Manchester

  • Study site

    Nottingham

  • Study site

    Sutton

Other trials in United Kingdom

Serbia3 sites

  • Study site

    Belgrade

  • Study site

    Kamenitz

  • Study site

    Niš

Other trials in Serbia

France2 sites

  • Study site

    Rabat-les-Trois-Seigneurs

  • Study site

    Tunis

Other trials in France

Lithuania2 sites

  • Study site

    Kaunas

  • Study site

    Vilnius

Other trials in Lithuania

Portugal2 sites

  • Study site

    Coimbra

  • Study site

    Matosinhos Municipality

Other trials in Portugal

Estonia1 site

  • Study site

    Tartu

Other trials in Estonia

Latvia1 site

  • Study site

    Riga

Other trials in Latvia

About this study

Official title: 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.

Read the 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.

Conditions
Breast Cancer
Being tested
Docetaxel, DOXIL
Keywords
Breast Cancer, Advanced breast cancer, Breast Tumors, Cancer of Breast, Human Mammary Carcinoma, Mammary Neoplasms, Human, DOXIL, Docetaxel
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DocetaxelDrug

    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

  • DOXILDrug

    Also called DOXIL in combination with Docataxel

    DOXIL 30 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.

Study groups in NCT00091442
Study groupRoleWhat they receive
DOXIL and docetaxel combination therapyExperimentalDOXIL 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.
Receives: Drug: Docetaxel; Drug: DOXIL
Docetaxel monotherapyActive comparatorDocetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle
Receives: Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Overall Survival

    Time interval in months between the date of randomization and the participant's death from any cause.

    Measured: 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

  2. Response Rate: Number of Participants in the Evaluable Population Who Achieved a Complete Response (CR) or Partial Response (PR)

    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).

    Measured: Up to 30 to 42 days after last dose of study medication

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2004 (estimated)
  2. Study startSep 2004
  3. Primary completionDec 2008
  4. Study completionDec 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
751 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00091442
Sponsor's protocol ID
CR004120
Other IDs
DOXILBCA3001
Status last verified
Apr 2014
First submitted
8 Sep 2004
Last updated
21 Apr 2014
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Docetaxel and DOXIL in people with Breast Cancer, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 147 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 147 sites in Russia, United States, Poland, Ukraine, Romania and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00091442.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2014.

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