E7389 Versus Treatment of Physician's Choice in Patients With Locally Recurrent or Metastatic Breast Cancer
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
2 other identifiers
interventional
762
16 countries
131
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Nov 2006
Typical duration for phase_3 breast-cancer
131 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2006
CompletedFirst Posted
Study publicly available on registry
October 17, 2006
CompletedStudy Start
First participant enrolled
November 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedResults Posted
Study results publicly available
January 30, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedJanuary 7, 2020
July 1, 2014
2.5 years
October 13, 2006
December 22, 2011
December 17, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall Survival
Defined as the time from the date of randomization until the date of death from any cause.
From date of randomization until death from any cause
Secondary Outcomes (4)
Progression-Free Survival.
Until disease progression or death.
Best Overall Response
Until Day 30 or every 3 months during Follow-up period for patients who complete study without PD.
Duration of Response.
From first documented CR or PR until disease progression or death.
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
From start of study drug administration up to 30 days after the last dose of study drug (approximately up to 42 months)
Study Arms (2)
1
EXPERIMENTAL2
ACTIVE COMPARATORInterventions
1.4 mg/m\^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days.
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.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
- +3 more criteria
You may not qualify if:
- 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.
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
- Eisai Limitedcollaborator
Study Sites (137)
US Oncology St. Vincent's Hospital - Bruno Cancer Center
Birmingham, Alabama, United States
Bellflower Satellite
Bellflower, California, United States
Research Center
Gilroy, California, 95020, United States
US Oncology
Denver, Colorado, United States
Florida Cancer Research Institute
Davie, Florida, United States
Innovative Medical Research of South Florida, Inc.
Miami, Florida, 33179, United States
Peachtree Hematology/Oncology Consultants, PC
Atlanta, Georgia, United States
US Oncology
Niles, Illinois, United States
US Oncology
Indianapolis, Indiana, United States
University of Iowa Hospital and Clinic
Iowa City, Iowa, United States
Hematology Oncology Clinic
Baton Rouge, Louisiana, United States
Oncology Care Associates, P.L.L.C.
Saint Joseph, Michigan, United States
US Oncology
Columbia, Missouri, United States
Montana Cancer Specialists
Missoula, Montana, 59820, United States
US Oncology
Las Vegas, Nevada, United States
US Oncology
Albany, New York, United States
North Shore Hematology/Oncology Associates
East Setauket, New York, United States
Weill Cornell Breast Cancer Center
New York, New York, United States
Carolina Hematology Oncology Associates
Charlotte, North Carolina, United States
US Oncology
Raleigh, North Carolina, United States
US Oncology
Eugene, Oregon, United States
St. Vincent Medical Center
Portland, Oregon, United States
US Oncology
Bedford, Texas, United States
US Oncology
Dallas, Texas, United States
US Oncology
Houston, Texas, United States
US Oncology
McAllen, Texas, United States
US Oncology
Midland, Texas, United States
US Oncology
Tyler, Texas, United States
US Oncology
Spokane, Washington, United States
Northwest Medical Specialists
Tacoma, Washington, 98401, United States
US Oncology
Vancouver, Washington, United States
US Oncology
Yakima, Washington, United States
Instituto Oncologico "Las Heras"
Bahía Blanca, Buenos Aires, B8000ILF, Argentina
Hospital Britanico
C.a.b.a, Buenos Aires, C1280AEB, Argentina
Instituto FIDES especialidades Medicas
La Plata, Buenos Aires, 1900, Argentina
Breast Clinica de la Mama
La Plata, Buenos Aires, Argentina
CITEM
Quilmes, Buenos Aires, Argentina
CER Instituto Medico
Quilmes Oeste, Buenos Aires, Argentina
Instituto CAICI
Rosario, Pcia. Santa Fe, S2000PBJ, Argentina
Centro Medico San Roque
San Miguel de Tucumán, San Miguel de Tucuman, Argentina
Hosptial Interzonal General de Mar del Plata
Buenos Aires, 7600, Argentina
Clinica Universitaria Privada Reina Fabiola
Córdoba, Argentina
Sanatorio Frances
Córdoba, Argentina
Instituto de Oncologia y Especialidades Medicas
Rosario Santa Fe, 2000, Argentina
Clinica Especializada ISIS
Santa Fe, S3000FFU, Argentina
The Queen Elizabeth Hospital
Southport, Queensland, 4215, Australia
Servicio De Oncologia
Woodville South, South Australia, 5011, Australia
Maroondah Breast Clinic
Melbourne, 3135, Australia
Mater Medical Centre
North Sydney, 2060, Australia
Mount Hospital
Perth, 6000, Australia
Royal Perth Hospital, Department of Medical Oncology
Perth, 6000, Australia
Medizinische Universitatsklinik Graz
Graz Steiermark, 8036, Austria
Salzburger Landeskliniken Universitatsklinik fur Innere medizin III
Salzburg, 5020, Austria
Institut Jules Bordet
Brussels, 1000, Belgium
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Centre Hospitalier Notre-Dame - Reine Fabiola
Charleroi, 6000, Belgium
UZ Gent
Ghent, B-9000, Belgium
AZ Groeninge, Campus Maria's Voorzienigheid
Kortrijk, 8500, Belgium
Centro Regional Integrado de Oncologia-CRIO
Fortaleza, Ceará, Brazil
Centro de Pesquisas e Estudios do Centro Goiano
Giana, Goiás, Brazil
Hospital Erasto Gaertner
Curitiba, Pará, Brazil
Instituto Nacional do Cancer-Unidade III (INCA III)
Rio de Janiero, Rio de Janeiro, Brazil
CPO-Centro de Pesquisas em Oncologia
Porto Alegre, Rio Grande do Sul, Brazil
CEPHO-Centro de Estudos e Pesquisa de Hematologia e oncologia
Santo André, São Paulo, Brazil
Santo Andre Diagnosticos e Tratamentos
Santo André, São Paulo, Brazil
Clinica de Oncologia Medica
São Paulo, São Paulo, Brazil
Hospital Amaral Carvalho
Vila Assis, São Paulo, Brazil
The Ottawa Hospital Regional Cancer Center
Ottawa, Ontario, Canada
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N 3M5, Canada
McGill University Health Centre, Department of Oncology, Gerald Bronfman Center
Montreal, Quebec, Canada
Clinical Hospital Osijek
Osijek, 31000, Croatia
University Hospital Center Zagreb
Zagreb, 1000, Croatia
University Hospital for Tumors Zagreb
Zagreb, 1000, Croatia
Masaryk Memorial Cancer Institute
Brno, 656 53, Czechia
Hospital Jihlava
Jihlava, 58633, Czechia
Clinic of Radiotherapy and Oncology
Prague, 100 34, Czechia
General Faculty Hospital Prague
Prague, 128 08, Czechia
Fakultni Thomayerova Nemocnice
Prague, 14059, Czechia
Ustav radia ni onkologie 1. LF UK a FNB
Prague, 18000, Czechia
Centre Paul Papin
Agners Cedex 01, 46033, France
Hopital Jean Minjoz
Besançon, 25030, France
Polyclinique Boredaux Nord Aquitaine
Bordeaux, 33300, France
Centre Francois Baclesse Caen
Caen, 14076, France
Centre Jean Perrin - CRLC
Clermont-Ferrand, 63011, France
Centre Georges-Francois Lecierc
Dijon, 21079, France
Hopital Edourad Herriot
Lyon, 69008, France
Institut Curie
Paris, 75005, France
Clinique Armoricaine de Radiologie
Saint-Brieuc, 22015, France
Hopital Bretonneau
Tours, 37044, France
Semmelweis Medical University, III. Dep. of Internal Med.
Budapest, 1125, Hungary
Debrecen Medical University, Department of Oncology
Debrecen, 4012, Hungary
University of Pecs
Pécs, 7200, Hungary
Markusovszky Teaching Hospital, Dept. of Oncoradiology, Sec. Med. Oncology
Szombathely, 9700, Hungary
Azienda Ospedaliera Careggi
Firenze (FI), 50139, Italy
Ospedale San Martino
Genova, 16132, Italy
Ospedale "Vito Fazzi" - Lecce
Lecce (LE), 73100, Italy
Istituto Scientifico San Raffaele
Milan, 20132, Italy
Ospedale San Filippo Neri
Roma, 00135, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
UO di Oncologia
Sora, 03039, Italy
Akademickie Centrum Kliniczne Szpital Akademii Medycznej w
Gdansk, 80952, Poland
Szpital Morski im PCK w Gdyni Gdynskie Centrum Onkologii
Gdynia, 81519, Poland
Centrum Onkologii Instytut M. Sklodowskiej Curie w Warszawie Oddzial Gilwice
Gilwice, 44101, Poland
Centrum Onkologii Instytut M Sklodowskiej Curie, Oddzial w Krakowie
Krakow, 31-115, Poland
Szpital Kiniczny Przemienienia Panskiego Uniwersyteu Medycznego im Karola Marcinkowskiego w Poznaniu
Poznan, 61878, Poland
Zachodniopomorski e Centrum
Szczecin, 71-730, Poland
Centrum Onkologii Instytut im M. Sklodowskiej Curie w Warszawie
Warsaw, 02781, Poland
Republic Clinical Oncology Dispensary
Izhervsk Udmurtia, 426009, Russia
Kazan State Medical University
Kazan', 420012, Russia
Krasnodar Territory Clinical Oncology Center
Krasnodar, 350040, Russia
Burdenko Main Military Hospital
Moscow, 105229, Russia
Nizhniy Novgorod City Oncology Center
Nizhny Novgorod, 603081, Russia
City Clinical Hospital #1
Novosibirisk, 630047, Russia
Republican Oncology Center
Petrozavodsk, 185007, Russia
State Institution of Healthcare Stavropol Region clinical Oncology dispensary
Pyatigorsk, Russia
Pavlov Medical University
Saint Petersburg, 190722, Russia
St Petersburg City Oncology Center
Saint Petersburg, 197022, Russia
NN Petrov Research Institute of Oncology
Saint Petersburg, 197758, Russia
Tomsk Regional Oncology Dispensary
Tomsk, 634050, Russia
GUZ YO Regional Clinical Oncology Hospital
Yaroslavl, 150054, Russia
Panorama Medical Centre
Panorama, Cape Town, 7500, South Africa
Eastern Cape Oncology Centre, GVI, St Georges Hospital
Port Elizabeth, Eastern Cape, 6001, South Africa
Sandton Oncology Centre
Johannesburg, 2057, South Africa
Pretoria Academic Hospital
Pretoria, 0001, South Africa
Hospital Vall d Hebron
Barcelona, 08035, Spain
Hospital Mutua de Terrassa
Barcelona, E-08221, Spain
Hospital Universitario de Girona Dr. Josep Trueta
Girona, 17007, Spain
Complejo Hospitalario de Jaen
Jaén, E-23007, Spain
Hospital Unversitatio de Salamanca
Salamanca, E37007, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, E-38320, Spain
Hospital General Virgen del Rocio
Seville, E-41013, Spain
Hospital Clinico de Zaragoza
Zanagoza, 50009, Spain
Kantonsspital Aarau
Aarau, 5001, Switzerland
Inselspital Bern
Bern Bern, 3010, Switzerland
Kantonsspital Oncology Haematology
Sankt Gallen, CH9007, Switzerland
Spital Thun-Simmental AG
Thun, 3600, Switzerland
Kantonsspital Winterhur
Winterhur, CH-8401, Switzerland
Related Publications (7)
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.
PMID: 34037241DERIVEDMiyoshi 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.
PMID: 32133606DERIVEDWedam 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.
PMID: 29522361DERIVEDTwelves 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.
PMID: 27391598DERIVEDMuss 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.
PMID: 24682463DERIVEDCortes 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.
PMID: 21376385DERIVEDTwelves 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.
PMID: 20299316DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Eisai Medical Information
- Organization
- Eisai Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2006
First Posted
October 17, 2006
Study Start
November 1, 2006
Primary Completion
May 1, 2009
Study Completion
June 1, 2013
Last Updated
January 7, 2020
Results First Posted
January 30, 2012
Record last verified: 2014-07