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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: E7389; Drug: Physician's Choice

• Study Type: Interventional
• Enrollment (Actual): 762
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, 7600
    • Hosptial Interzonal General de Mar del Plata
  • Cordoba, Argentina
    • Clinica Universitaria Privada Reina Fabiola
  • Cordoba, Argentina
    • Sanatorio Frances
  • Rosario Santa Fe, Argentina, 2000
    • Instituto de Oncologia y Especialidades Medicas
  • Santa Fe, Argentina, S3000FFU
    • Clinica Especializada ISIS
  • Buenos Aires
    • Bahia Blanca, Buenos Aires, Argentina, B8000ILF
      • Instituto Oncologico "Las Heras"
    • C.a.b.a, Buenos Aires, Argentina, C1280AEB
      • Hospital Británico
    • La Plata, Buenos Aires, Argentina, 1900
      • Instituto FIDES especialidades Medicas
    • La Plata, Buenos Aires, Argentina
      • Breast clinica de la mama
    • Quilmes, Buenos Aires, Argentina
      • CITEM
    • Quilmes Oeste, Buenos Aires, Argentina
      • Cer Instituto Medico
  • Pcia. Santa Fe
    • Rosario, Pcia. Santa Fe, Argentina, S2000PBJ
      • Instituto CAICI
  • San Miguel De Tucuman
    • Tucuman, San Miguel De Tucuman, Argentina
      • Centro Medico San Roque
• Australia
  • Melbourne, Australia, 3135
    • Maroondah Breast Clinic
  • North Sydney, Australia, 2060
    • Mater Medical Centre
  • Perth, Australia, 6000
    • Mount Hospital
  • Perth, Australia, 6000
    • Royal Perth Hospital, Department of Medical Oncology
  • Queensland
    • Southport, Queensland, Australia, 4215
      • The Queen Elizabeth Hospital
  • South Australia
    • Woodville South, South Australia, Australia, 5011
      • Servicio de Oncología
• Austria
  • Graz Steiermark, Austria, 8036
    • Medizinische Universitätsklinik Graz
  • Salzburg, Austria, 5020
    • Salzburger Landeskliniken Universitatsklinik fur Innere medizin III
• Belgium
  • Brussels, Belgium, 1000
    • Institut Jules Bordet
  • Bruxelles, Belgium, 1200
    • Cliniques universitaires Saint-Luc
  • Charleroi, Belgium, 6000
    • Centre Hospitalier Notre-Dame - Reine Fabiola
  • Gent, Belgium, B-9000
    • UZ Gent
  • Kortrijk, Belgium, 8500
    • AZ Groeninge, Campus Maria's Voorzienigheid
• Brazil
  • CE
    • Fortaleza, CE, Brazil
      • Centro Regional Integrado de Oncologia-CRIO
  • GO
    • Giana, GO, Brazil
      • Centro de Pesquisas e Estudios do Centro Goiano
  • PA
    • Curitiba, PA, Brazil
      • Hospital Erasto Gaertner
  • RJ
    • Rio De Janiero, RJ, Brazil
      • Instituto Nacional do Cancer-Unidade III (INCA III)
  • RS
    • Porto Alegre, RS, Brazil
      • CPO-Centro de Pesquisas em Oncologia
  • SP
    • Santo Andre, SP, Brazil
      • CEPHO-Centro de Estudos e Pesquisa de Hematologia e oncologia
    • Santo Andre, SP, Brazil
      • Santo Andre Diagnosticos e Tratamentos
    • Sao Paulo, SP, Brazil
      • Clinica de Oncologia Medica
    • Vila Assis, SP, Brazil
      • Hospital Amaral Carvalho
• Canada
  • Ontario
    • Ottawa, Ontario, Canada
      • The Ottawa Hospital Regional Cancer Center
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Odette Cancer Centre
  • Quebec
    • Montreal, Quebec, Canada
      • McGill University Health Centre, Department of Oncology, Gerald Bronfman Center
• Croatia
  • Osijek, Croatia, 31000
    • Clinical Hospital Osijek
  • Zagreb, Croatia, 1000
    • University Hospital Center Zagreb
  • Zagreb, Croatia, 1000
    • University Hospital for Tumors Zagreb
• Czechia
  • Brno, Czechia, 656 53
    • Masaryk Memorial Cancer Institute
  • Jihlava, Czechia, 58633
    • Hospital Jihlava
  • Prague, Czechia, 128 08
    • General faculty hospital Prague
  • Prague, Czechia, 14059
    • Fakultni Thomayerova nemocnice
  • Praha, Czechia, 18000
    • Ustav radia ni onkologie 1. LF UK a FNB
  • Praha 10, Czechia, 100 34
    • Clinic of Radiotherapy and Oncology
• France
  • Agners Cedex 01, France, 46033
    • Centre Paul Papin
  • Besancon, France, 25030
    • Hôpital Jean Minjoz
  • Bordeaux, France, 33300
    • Polyclinique Boredaux Nord Aquitaine
  • Caen Cedex 05, France, 14076
    • Centre Francois Baclesse Caen
  • Clermont-Ferrand Cedex 01, France, 63011
    • Centre Jean Perrin - CRLC
  • Dijon Cedex, France, 21079
    • Centre Georges-Francois Lecierc
  • Lyon, France, 69008
    • Hôpital Edourad Herriot
  • Paris, France, 75005
    • Institut Curie
  • Saint Brieuc Cedex, France, 22015
    • Clinique Armoricaine de Radiologie
  • Tours Cedex, France, 37044
    • Hôpital Bretonneau
• Hungary
  • Budapest, Hungary, 1125
    • Semmelweis Medical University, III. Dep. of Internal Med.
  • Debrecen, Hungary, 4012
    • Debrecen Medical University, Department of Oncology
  • Pecs, Hungary, 7200
    • University of Pecs
  • Szombathely, Hungary, 9700
    • Markusovszky Teaching Hospital, Dept. of Oncoradiology, Sec. Med. Oncology
• Italy
  • Firenze (FI), Italy, 50139
    • Azienda Ospedaliera Careggi
  • Genova, Italy, 16132
    • Ospedale San Martino
  • Lecce (LE), Italy, 73100
    • Ospedale "Vito Fazzi" - Lecce
  • Milano, Italy, 20132
    • Istituto Scientifico San Raffaele
  • Roma, Italy, 00135
    • Ospedale San Filippo Neri
  • Rozzano, Italy, 20089
    • Istituto Clinico Humanitas
  • Sora, Italy, 03039
    • UO di Oncologia
• Poland
  • Gdansk, Poland, 80952
    • Akademickie Centrum Kliniczne Szpital Akademii Medycznej w
  • Gdynia, Poland, 81519
    • Szpital Morski im PCK w Gdyni Gdynskie Centrum Onkologii
  • Gilwice, Poland, 44101
    • Centrum Onkologii Instytut M. Sklodowskiej Curie w Warszawie Oddzial Gilwice
  • Krakow, Poland, 31-115
    • Centrum Onkologii Instytut M Sklodowskiej Curie, Oddzial w Krakowie
  • Poznan, Poland, 61878
    • Szpital Kiniczny Przemienienia Panskiego Uniwersyteu Medycznego im Karola Marcinkowskiego w Poznaniu
  • Szczecin, Poland, 71-730
    • Zachodniopomorski e Centrum
  • Warszawa, Poland, 02781
    • Centrum Onkologii Instytut im M. Sklodowskiej Curie w Warszawie
• Russian Federation
  • Izhervsk Udmurtia, Russian Federation, 426009
    • Republic Clinical Oncology Dispensary
  • Kazan, Russian Federation, 420012
    • Kazan State Medical University
  • Krasnodar, Russian Federation, 350040
    • Krasnodar Territory Clinical Oncology Center
  • Moscow, Russian Federation, 105229
    • Burdenko Main Military Hospital
  • Nizhny Novgorod, Russian Federation, 603081
    • Nizhniy Novgorod City Oncology Center
  • Novosibirisk, Russian Federation, 630047
    • City Clinical Hospital #1
  • Petrozavodsk, Russian Federation, 185007
    • Republican Oncology Center
  • Pyatigorsk, Russian Federation
    • State Institution of Healthcare Stavropol Region clinical Oncology dispensary
  • St Petersburg, Russian Federation, 197022
    • St Petersburg City Oncology Center
  • St. Petersburg, Russian Federation, 190722
    • Pavlov Medical University
  • St. Petersburg, Russian Federation, 197758
    • NN Petrov Research Institute of Oncology
  • Tomsk, Russian Federation, 634050
    • Tomsk Regional Oncology Dispensary
  • Yaroslavl, Russian Federation, 150054
    • GUZ YO Regional Clinical Oncology Hospital
• South Africa
  • Johannesburg, South Africa, 2057
    • Sandton Oncology Centre
  • Pretoria, South Africa, 0001
    • Pretoria Academic Hospital
  • Cape Town
    • Panorama, Cape Town, South Africa, 7500
      • Panorama Medical Centre
  • Eastern Cape
    • Port Elizabeth, Eastern Cape, South Africa, 6001
      • Eastern Cape Oncology Centre, GVI, St Georges Hospital
• Spain
  • Barcelona, Spain, 08035
    • Hospital Vall d Hebron
  • Barcelona, Spain, E-08221
    • Hospital Mútua de Terrassa
  • Gerona, Spain, 17007
    • Hospital Universitario de Girona Dr. Josep Trueta
  • Jaen, Spain, E-23007
    • Complejo Hospitalario de Jaén
  • Salamanca, Spain, E37007
    • Hospital Unversitatio de Salamanca
  • Santa Cruz de Tenerife, Spain, E-38320
    • Hospital Universitario de Canarias
  • Sevilla, Spain, E-41013
    • Hospital General Virgen del Rocio
  • Zanagoza, Spain, 50009
    • Hospital Clínico de Zaragoza
• Switzerland
  • Aarau, Switzerland, 5001
    • Kantonsspital Aarau
  • Bern Bern, Switzerland, 3010
    • Inselspital Bern
  • St. Gallen, Switzerland, CH9007
    • Kantonsspital Oncology Haematology
  • Thun, Switzerland, 3600
    • Spital Thun-Simmental AG
  • Winterhur, Switzerland, CH-8401
    • Kantonsspital Winterhur
• United States
  • Alabama
    • Birmingham, Alabama, United States
      • US Oncology St. Vincent's Hospital - Bruno Cancer Center
  • California
    • Bellflower, California, United States
      • Bellflower Satellite
    • Gilroy, California, United States, 95020
      • Research Center
  • Colorado
    • Denver, Colorado, United States
      • US Oncology
  • Florida
    • Davie, Florida, United States
      • Florida Cancer Research Institute
    • Miami, Florida, United States, 33179
      • Innovative Medical Research of South Florida, Inc.
  • Georgia
    • Atlanta, Georgia, United States
      • Peachtree Hematology/Oncology Consultants, PC
  • Illinois
    • Niles, Illinois, United States
      • US Oncology
  • Indiana
    • Indianapolis, Indiana, United States
      • US Oncology
  • Iowa
    • Iowa City, Iowa, United States
      • University of Iowa Hospital and Clinic
  • Louisiana
    • Baton Rouge, Louisiana, United States
      • Hematology Oncology Clinic
  • Michigan
    • Saint Joseph, Michigan, United States
      • Oncology Care Associates, P.L.L.C.
  • Missouri
    • Columbia, Missouri, United States
      • US Oncology
  • Montana
    • Missoula, Montana, United States, 59820
      • Montana Cancer Specialists
  • Nevada
    • Las Vegas, Nevada, United States
      • US Oncology
  • New York
    • Albany, New York, United States
      • US Oncology
    • East Setauket, New York, United States
      • North Shore Hematology/Oncology Associates
    • New York, New York, United States
      • Weill Cornell Breast Cancer Center
  • North Carolina
    • Charlotte, North Carolina, United States
      • Carolina Hematology Oncology Associates
    • Raleigh, North Carolina, United States
      • US Oncology
  • Oregon
    • Eugene, Oregon, United States
      • US Oncology
    • Portland, Oregon, United States
      • St. Vincent Medical Center
  • Texas
    • 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
  • Washington
    • Spokane, Washington, United States
      • US Oncology
    • Tacoma, Washington, United States, 98401
      • Northwest Medical Specialists
    • Vancouver, Washington, United States
      • US Oncology
    • Yakima, Washington, United States
      • US Oncology

Participation Criteria

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:

1. 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.

2. 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.
3. Resolution of all chemotherapy or radiation-related toxicities to Grade 1 severity or lower, except for stable sensory neuropathy <= Grade 2 and alopecia.
4. Age >= 18 years.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
6. Life expectancy of >= 3 months.
7. 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.
8. 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.
9. 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.
10. Patients willing and able to comply with the study protocol for the duration of the study.
11. Written informed consent prior to any study-specific screening procedures with the understanding that the patient may withdraw consent at any time without prejudice.

EXCLUSION CRITERIA

1. 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.
2. Radiation therapy encompassing > 30% of marrow.
3. Prior treatment with mitomycin C or nitrosourea.
4. Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.
5. 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.
6. Patients with meningeal carcinomatosis.
7. 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.
8. 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.
9. Severe/uncontrolled intercurrent illness/infection.
10. 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).
11. Patients with organ allografts requiring immunosuppression.
12. Patients with known positive HIV status.
13. 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.
14. Patients with pre-existing neuropathy > Grade 2.
15. Patients with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivative.
16. Patients who participated in a prior E7389 clinical trial whether or not E7389 was received.
17. Patients with other significant disease or disorders that, in the Investigator's opinion, would exclude the patient from the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: E7389; 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days.
Active Comparator: 2	Drug: Physician's Choice; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Until disease progression or death.
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).	Until Day 30 or every 3 months during Follow-up period for patients who complete study without PD.
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.	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)

Collaborators and Investigators

• Sponsor: Eisai Inc.
• Collaborators: Eisai Limited

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2006
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: October 13, 2006
• First Submitted That Met QC Criteria: October 16, 2006
• First Posted (Estimate): October 17, 2006

Study Record Updates

• Last Update Posted (Actual): January 7, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2019
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: metastatic breast cancer; Locally recurrent breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: E7389-G000-305; 2006-001949-34 (EudraCT Number)