AzTrials
AzTrials

Breast CancerPhase 3NCT00388726

E7389 Versus Treatment of Physician's Choice in Patients With Locally Recurrent or Metastatic Breast Cancer

A Phase 3 study testing E7389 and Physician's Choice in people with Breast Cancer, run by Eisai Inc. at 137 sites in 17 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 this study is to compare Overall Survival (OS), Progression Free Survival (PFS), objective tumor response rate, duration of response, and safety in patients treated with E7389 versus the Treatment of Physician's Choice (TPC) in patients with locally recurrent or metastatic 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?
E7389 and Physician's Choice
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
762 participants
Where
137 sitesin 17 countries
Study dates
Nov 2006to Jun 2013
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

  • Female patients with histologically or cytologically confirmed carcinoma of the breast.
  • Every effort should be made to make paraffin embedded tissue or slides from the diagnostic biopsy or surgical specimen available for confirmation of diagnosis.
  • Patients with locally recurrent or metastatic disease who have received at least two (and not more than five) prior chemotherapeutic regimens for breast cancer, at least two of which were administered for treatment of locally recurrent and/or metastatic disease.
  • Prior therapy must be documented by the following criteria prior to entry onto study:
  • Regimens must have included an anthracycline (e.g., doxorubicin, epirubicin) and a taxane (e.g., paclitaxel, docetaxel) in any combination or order. Treatment with any of these agents is not required if they are contraindicated for a certain patient.
  • One or two of these regimens may have been administered as adjuvant and/or neoadjuvant therapy, but at least 2 must have been given for relapsed or metastatic disease.
Show all 18Show fewer
  • Patients must have proved refractory to the most recent chemotherapy, documented by progression on or within six (6) months of therapy.
  • Patients with Human Epidermal Growth Factor 2 (HER2/neu) positive tumors may additionally have been treated with trastuzumab.
  • Patients may have additionally been treated with anti-hormonal therapy.
  • Resolution of all chemotherapy or radiation-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy <= Grade 2 and alopecia.
  • Age >= 18 years.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
  • Life expectancy of >= 3 months.
  • Adequate renal function as evidenced by serum creatinine <= 2.0 mg/dL or calculated creatinine clearance >= 40 mL/min per the Cockcroft and Gault formula.
  • Adequate bone marrow function as evidenced by absolute neutrophil count (ANC) >= 1.5 x 10^9/L, hemoglobin >= 10.0 g/dL (a hemoglobin <10.0 g/dL is acceptable if it is corrected by growth factor or transfusion), and platelet count >= 100 x 10^9/L.
  • Adequate liver function as evidenced by bilirubin <= 1.5 times the upper limits of normal (ULN) and alkaline phosphatase, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) <= 3 x ULN (in the case of liver metastases <= 5 x ULN), unless there are bone metastases, in which case liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase. In case alkaline phosphatase is >3 x ULN (in absence of liver metastases) or > 5 x ULN (in presence of liver metastases) AND patient is known to have bone metastases, the liver specific alkaline phosphatase must be separated from the total and used to assess the liver function instead of the total alkaline phosphatase.
  • Patients willing and able to comply with the study protocol for the duration of the study.
  • Written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.

Who cannot join

  • Patients who have received any of the following treatments within the specified period before E7389 or TPC treatment start:
  • chemotherapy, radiation, trastuzumab or hormonal therapy within three weeks.
  • any investigational drug within four weeks.
  • Radiation therapy encompassing > 30% of marrow.
  • Prior treatment with mitomycin C or nitrosourea.
  • Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.
Show all 19Show fewer
  • Patients with brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (e.g., radiologic) and/or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment; radiographic stability should be determined by comparing a contrast-enhanced computed tomography or magnetic resonance imaging brain scan performed during screening to a prior scan performed at least 4 weeks earlier.
  • Patients with meningeal carcinomatosis.
  • Patients who are receiving anti-coagulant therapy with warfarin or related compounds, other than for line patency, and cannot be changed to heparin-based therapy if randomized to E7389 are not eligible. If a patient is to continue on mini-dose warfarin, then the prothrombin time (PT) or international normalized ratio (INR) must be closely monitored.
  • Women who are pregnant or breast-feeding; women of childbearing potential with either a positive pregnancy test at screening or no pregnancy test; women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception in the opinion of the Investigator. Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
  • Severe/uncontrolled intercurrent illness/infection.
  • Significant cardiovascular impairment (history of congestive heart failure > New York Heart Association grade II, unstable angina or myocardial infarction within the past six months, or serious cardiac arrhythmia).
  • Patients with organ allografts requiring immunosuppression.
  • Patients with known positive HIV status.
  • Patients who have had a prior malignancy, other than previous breast cancer, carcinoma in situ of the cervix, or non-melanoma skin cancer, unless the prior malignancy was diagnosed and definitively treated >= 5 years previously with no subsequent evidence of recurrence.
  • Patients with pre-existing neuropathy > Grade 2.
  • Patients with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivative.
  • Patients who participated in a prior E7389 clinical trial whether or not E7389 was received.
  • Patients with other significant disease or disorders that, in the Investigator's opinion, would exclude the patient from the study.

Trial locations and contacts

137 sites in 17 countries.

137 sites in 17 countries

United States32 sites

  • US Oncology

    Albany, New York

  • Peachtree Hematology/Oncology Consultants, PC

    Atlanta, Georgia

  • Hematology Oncology Clinic

    Baton Rouge, Louisiana

  • US Oncology

    Bedford, Texas

  • Bellflower Satellite

    Bellflower, California

  • US Oncology St. Vincent's Hospital - Bruno Cancer Center

    Birmingham, Alabama

  • Carolina Hematology Oncology Associates

    Charlotte, North Carolina

  • US Oncology

    Columbia, Missouri

  • US Oncology

    Dallas, Texas

  • Florida Cancer Research Institute

    Davie, Florida

  • US Oncology

    Denver, Colorado

  • North Shore Hematology/Oncology Associates

    East Setauket, New York

  • US Oncology

    Eugene, Oregon

  • Research Center

    Gilroy, California, 95020

  • US Oncology

    Houston, Texas

  • US Oncology

    Indianapolis, Indiana

  • University of Iowa Hospital and Clinic

    Iowa City, Iowa

  • US Oncology

    Las Vegas, Nevada

  • US Oncology

    McAllen, Texas

  • Innovative Medical Research of South Florida, Inc.

    Miami, Florida, 33179

  • US Oncology

    Midland, Texas

  • Montana Cancer Specialists

    Missoula, Montana, 59820

  • Weill Cornell Breast Cancer Center

    New York, New York

  • US Oncology

    Niles, Illinois

  • St. Vincent Medical Center

    Portland, Oregon

  • US Oncology

    Raleigh, North Carolina

  • Oncology Care Associates, P.L.L.C.

    Saint Joseph, Michigan

  • US Oncology

    Spokane, Washington

  • Northwest Medical Specialists

    Tacoma, Washington, 98401

  • US Oncology

    Tyler, Texas

  • US Oncology

    Vancouver, Washington

  • US Oncology

    Yakima, Washington

Other trials in United States

Argentina13 sites

  • Instituto Oncologico "Las Heras"

    Bahía Blanca, Buenos Aires, B8000ILF

  • Hosptial Interzonal General de Mar del Plata

    Buenos Aires, 7600

  • Hospital Britanico

    C.a.b.a, Buenos Aires, C1280AEB

  • Clinica Universitaria Privada Reina Fabiola

    Córdoba

  • Sanatorio Frances

    Córdoba

  • Instituto FIDES especialidades Medicas

    La Plata, Buenos Aires, 1900

  • Breast Clinica de la Mama

    La Plata, Buenos Aires

  • CITEM

    Quilmes, Buenos Aires

  • CER Instituto Medico

    Quilmes Oeste, Buenos Aires

  • Instituto CAICI

    Rosario, Pcia. Santa Fe, S2000PBJ

  • Instituto de Oncologia y Especialidades Medicas

    Rosario Santa Fe, 2000

  • Centro Medico San Roque

    San Miguel de Tucumán, San Miguel de Tucuman

  • Clinica Especializada ISIS

    Santa Fe, S3000FFU

Other trials in Argentina

Russia13 sites

  • Republic Clinical Oncology Dispensary

    Izhervsk Udmurtia, 426009

  • Kazan State Medical University

    Kazan', 420012

  • Krasnodar Territory Clinical Oncology Center

    Krasnodar, 350040

  • Burdenko Main Military Hospital

    Moscow, 105229

  • Nizhniy Novgorod City Oncology Center

    Nizhny Novgorod, 603081

  • City Clinical Hospital #1

    Novosibirisk, 630047

  • Republican Oncology Center

    Petrozavodsk, 185007

  • State Institution of Healthcare Stavropol Region clinical Oncology dispensary

    Pyatigorsk

  • Pavlov Medical University

    Saint Petersburg, 190722

  • St Petersburg City Oncology Center

    Saint Petersburg, 197022

  • NN Petrov Research Institute of Oncology

    Saint Petersburg, 197758

  • Tomsk Regional Oncology Dispensary

    Tomsk, 634050

  • GUZ YO Regional Clinical Oncology Hospital

    Yaroslavl, 150054

Other trials in Russia

France10 sites

  • Centre Paul Papin

    Agners Cedex 01, 46033

  • Hopital Jean Minjoz

    Besançon, 25030

  • Polyclinique Boredaux Nord Aquitaine

    Bordeaux, 33300

  • Centre Francois Baclesse Caen

    Caen, 14076

  • Centre Jean Perrin - CRLC

    Clermont-Ferrand, 63011

  • Centre Georges-Francois Lecierc

    Dijon, 21079

  • Hopital Edourad Herriot

    Lyon, 69008

  • Institut Curie

    Paris, 75005

  • Clinique Armoricaine de Radiologie

    Saint-Brieuc, 22015

  • Hopital Bretonneau

    Tours, 37044

Other trials in France

Brazil9 sites

  • Hospital Erasto Gaertner

    Curitiba, Pará

  • Centro Regional Integrado de Oncologia-CRIO

    Fortaleza, Ceará

  • Centro de Pesquisas e Estudios do Centro Goiano

    Giana, Goiás

  • CPO-Centro de Pesquisas em Oncologia

    Porto Alegre, Rio Grande do Sul

  • Instituto Nacional do Cancer-Unidade III (INCA III)

    Rio de Janiero, Rio de Janeiro

  • CEPHO-Centro de Estudos e Pesquisa de Hematologia e oncologia

    Santo André, São Paulo

  • Santo Andre Diagnosticos e Tratamentos

    Santo André, São Paulo

  • Clinica de Oncologia Medica

    São Paulo, São Paulo

  • Hospital Amaral Carvalho

    Vila Assis, São Paulo

Other trials in Brazil

Spain8 sites

  • Hospital Vall d Hebron

    Barcelona, 08035

  • Hospital Mutua de Terrassa

    Barcelona, E-08221

  • Hospital Universitario de Girona Dr. Josep Trueta

    Girona, 17007

  • Complejo Hospitalario de Jaen

    Jaén, E-23007

  • Hospital Unversitatio de Salamanca

    Salamanca, E37007

  • Hospital Universitario de Canarias

    Santa Cruz de Tenerife, E-38320

  • Hospital General Virgen del Rocio

    Seville, E-41013

  • Hospital Clinico de Zaragoza

    Zanagoza, 50009

Other trials in Spain

Italy7 sites

  • Azienda Ospedaliera Careggi

    Firenze (FI), 50139

  • Ospedale San Martino

    Genova, 16132

  • Ospedale "Vito Fazzi" - Lecce

    Lecce (LE), 73100

  • Istituto Scientifico San Raffaele

    Milan, 20132

  • Ospedale San Filippo Neri

    Roma, 00135

  • Istituto Clinico Humanitas

    Rozzano, 20089

  • UO di Oncologia

    Sora, 03039

Other trials in Italy

Poland7 sites

  • Akademickie Centrum Kliniczne Szpital Akademii Medycznej w

    Gdansk, 80952

  • Szpital Morski im PCK w Gdyni Gdynskie Centrum Onkologii

    Gdynia, 81519

  • Centrum Onkologii Instytut M. Sklodowskiej Curie w Warszawie Oddzial Gilwice

    Gilwice, 44101

  • Centrum Onkologii Instytut M Sklodowskiej Curie, Oddzial w Krakowie

    Krakow, 31-115

  • Szpital Kiniczny Przemienienia Panskiego Uniwersyteu Medycznego im Karola Marcinkowskiego w Poznaniu

    Poznan, 61878

  • Zachodniopomorski e Centrum

    Szczecin, 71-730

  • Centrum Onkologii Instytut im M. Sklodowskiej Curie w Warszawie

    Warsaw, 02781

Other trials in Poland

Australia6 sites

  • Maroondah Breast Clinic

    Melbourne, 3135

  • Mater Medical Centre

    North Sydney, 2060

  • Mount Hospital

    Perth, 6000

  • Royal Perth Hospital, Department of Medical Oncology

    Perth, 6000

  • The Queen Elizabeth Hospital

    Southport, Queensland, 4215

  • Servicio De Oncologia

    Woodville South, South Australia, 5011

Other trials in Australia

Czechia6 sites

  • Masaryk Memorial Cancer Institute

    Brno, 656 53

  • Hospital Jihlava

    Jihlava, 58633

  • Clinic of Radiotherapy and Oncology

    Prague, 100 34

  • General Faculty Hospital Prague

    Prague, 128 08

  • Fakultni Thomayerova Nemocnice

    Prague, 14059

  • Ustav radia ni onkologie 1. LF UK a FNB

    Prague, 18000

Other trials in Czechia

Belgium5 sites

  • Institut Jules Bordet

    Brussels, 1000

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Centre Hospitalier Notre-Dame - Reine Fabiola

    Charleroi, 6000

  • UZ Gent

    Ghent, B-9000

  • AZ Groeninge, Campus Maria's Voorzienigheid

    Kortrijk, 8500

Other trials in Belgium

Switzerland5 sites

  • Kantonsspital Aarau

    Aarau, 5001

  • Inselspital Bern

    Bern Bern, 3010

  • Kantonsspital Oncology Haematology

    Sankt Gallen, CH9007

  • Spital Thun-Simmental AG

    Thun, 3600

  • Kantonsspital Winterhur

    Winterhur, CH-8401

Other trials in Switzerland

Hungary4 sites

  • Semmelweis Medical University, III. Dep. of Internal Med.

    Budapest, 1125

  • Debrecen Medical University, Department of Oncology

    Debrecen, 4012

  • University of Pecs

    Pécs, 7200

  • Markusovszky Teaching Hospital, Dept. of Oncoradiology, Sec. Med. Oncology

    Szombathely, 9700

Other trials in Hungary

South Africa4 sites

  • Sandton Oncology Centre

    Johannesburg, 2057

  • Panorama Medical Centre

    Panorama, Cape Town, 7500

  • Eastern Cape Oncology Centre, GVI, St Georges Hospital

    Port Elizabeth, Eastern Cape, 6001

  • Pretoria Academic Hospital

    Pretoria, 0001

Other trials in South Africa

Canada3 sites

  • McGill University Health Centre, Department of Oncology, Gerald Bronfman Center

    Montreal, Quebec

  • The Ottawa Hospital Regional Cancer Center

    Ottawa, Ontario

  • Sunnybrook Odette Cancer Centre

    Toronto, Ontario, M4N 3M5

Other trials in Canada

Croatia3 sites

  • Clinical Hospital Osijek

    Osijek, 31000

  • University Hospital Center Zagreb

    Zagreb, 1000

  • University Hospital for Tumors Zagreb

    Zagreb, 1000

Other trials in Croatia

Austria2 sites

  • Medizinische Universitatsklinik Graz

    Graz Steiermark, 8036

  • Salzburger Landeskliniken Universitatsklinik fur Innere medizin III

    Salzburg, 5020

Other trials in Austria

About this study

Official title: The "EMBRACE" Trial: Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389. A Phase III Open-Label, Randomized, Parallel, Two-arm, Multi-center Study of E7389 Versus "Treatment of Physician's Choice" in Patients With Locally Recurrent, Metastatic Breast Cancer, Previously Treated With At Least Two and a Maximum of Five Prior Chemotherapy Regimens, Including an Anthracycline and a Taxane

The purpose of this study is to compare Overall Survival (OS), Progression Free Survival (PFS), objective tumor response rate, duration of response, and safety in patients treated with E7389 versus the Treatment of Physician's Choice (TPC) in patients with locally recurrent or metastatic breast cancer.

Conditions
Breast Cancer
Being tested
E7389, Physician's Choice
Keywords
Locally recurrent breast cancer, metastatic breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

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

  • E7389Drug

    1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days.

  • Physician's ChoiceDrug

    Treatment of the Physician's Choice defined as any single agent chemotherapy, hormonal treatment or biological therapy approved for the treatment of cancer; or palliative treatment or radiotherapy, administered according to local practice, if applicable.

Study groups in NCT00388726
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Drug: E7389
2Active comparatorNot described
Receives: Drug: Physician's Choice

What is being measured

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

  1. Overall Survival

    Defined as the time from the date of randomization until the date of death from any cause.

    Measured: From date of randomization until death from any cause

Secondary outcomes (4)

  1. Progression-Free Survival.

    Measured using Response Evaluation Criteria in Solid Tumors (RECIST) and defined as the time from the date of randomization until progressive disease or death from any cause in the absence of of progressive disease.

    Measured: Until disease progression or death.

  2. Best Overall Response

    Measured by RECIST criteria and defined as the best response from the start of treatment until disease progression or recurrence. Lesions measured by computed tomography (CT) scan and magnetic resonance imaging (MRI). Objective response rate: complete response (CR-disappearance of all lesions)+ partial response (PR-30% decrease in lesion diameter), Progressive Disease (PD-20% increase in lesion diameter), stable disease (SD-neither shrinkage nor increase of lesions).

    Measured: Until Day 30 or every 3 months during Follow-up period for patients who complete study without PD.

  3. Duration of Response.

    As measured by RECIST criteria and defined as the time from the first documented CR or PR until disease progression or death from any cause.

    Measured: From first documented CR or PR until disease progression or death.

  4. Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Measured: From start of study drug administration up to 30 days after the last dose of study drug (approximately up to 42 months)

Timeline

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

  1. First posted17 Oct 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionMay 2009
  4. Study completionJun 2013

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
762 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00388726
Sponsor's protocol ID
E7389-G000-305
Other IDs
2006-001949-34
Status last verified
Jul 2014
First submitted
13 Oct 2006
Last updated
7 Jan 2020

Publications

  • Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.

    PubMed 34037241

  • Miyoshi Y, Yoshimura Y, Saito K, Muramoto K, Sugawara M, Alexis K, Nomoto K, Nakamura S, Saeki T, Watanabe J, Perez-Garcia JM, Cortes J. High absolute lymphocyte counts are associated with longer overall survival in patients with metastatic breast cancer treated with eribulin-but not with treatment of physician's choice-in the EMBRACE study. Breast Cancer. 2020 Jul;27(4):706-715. doi: 10.1007/s12282-020-01067-2. Epub 2020 Mar 5.

    PubMed 32133606

  • Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.

    PubMed 29522361

  • Twelves C, Cortes J, Kaufman PA, Yelle L, Awada A, Binder TA, Olivo M, Song J, O'Shaughnessy JA, Jove M, Perez EA. "New" metastases are associated with a poorer prognosis than growth of pre-existing metastases in patients with metastatic breast cancer treated with chemotherapy. Breast Cancer Res. 2015 Dec 9;17(1):150. doi: 10.1186/s13058-015-0657-1.

    PubMed 27391598

  • Muss H, Cortes J, Vahdat LT, Cardoso F, Twelves C, Wanders J, Dutcus CE, Yang J, Seegobin S, O'Shaughnessy J. Eribulin monotherapy in patients aged 70 years and older with metastatic breast cancer. Oncologist. 2014 Apr;19(4):318-27. doi: 10.1634/theoncologist.2013-0282. Epub 2014 Mar 28.

    PubMed 24682463

  • Cortes J, O'Shaughnessy J, Loesch D, Blum JL, Vahdat LT, Petrakova K, Chollet P, Manikas A, Dieras V, Delozier T, Vladimirov V, Cardoso F, Koh H, Bougnoux P, Dutcus CE, Seegobin S, Mir D, Meneses N, Wanders J, Twelves C; EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389) investigators. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011 Mar 12;377(9769):914-23. doi: 10.1016/S0140-6736(11)60070-6. Epub 2011 Mar 2.

    PubMed 21376385

  • Twelves C, Cortes J, Vahdat LT, Wanders J, Akerele C, Kaufman PA. Phase III trials of eribulin mesylate (E7389) in extensively pretreated patients with locally recurrent or metastatic breast cancer. Clin Breast Cancer. 2010 Apr;10(2):160-3. doi: 10.3816/CBC.2010.n.023.

    PubMed 20299316

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing E7389 and Physician's Choice in people with Breast Cancer, run by Eisai Inc. at 137 sites in 17 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 18 inclusion and 19 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 7 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 137 sites in United States, Argentina, Russia, France, Brazil and 12 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 30 Jan 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?

Overall Survival (time frame: From date of randomization until death from any cause). 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 NCT00388726, which also lists 7 linked publications.

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 7 Jan 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in