Tesetaxel Plus Reduced Dose of Capecitabine vs. Capecitabine in HER2 Negative, HR Positive, LA/MBC

PHASE3TerminatedINTERVENTIONAL
Enrollment

685

Participants

Timeline

Start Date

December 21, 2017

Primary Completion Date

August 24, 2020

Study Completion Date

June 28, 2021

Conditions
Breast Cancer
Interventions
DRUG

Tesetaxel and Capecitabine

Tesetaxel plus reduced dose of Capecitabine

DRUG

Capecitabine

Capecitabine alone at approved dose

Trial Locations (207)

1000

Institut Jules Bordet, Brussels

1130

Ludwig Boltzmann Institut fur Klinische Onkologie und Photodynamische Therapie, Vienna

2076

Sydney Adventist Hospital, Wahroonga

2640

Border Medical Oncology, Albury

2900

UZA, Edegem

3199

Peninsula and South Eastern Haematology and Oncology Group, Frankston

4000

CHC-Sant Joseph Oncology-Hematology, Liège

7624

University of Pécs Department of Oncotherapy, Pécs

10003

HU San Pedro de Alcantara, Cáceres

10065

Memorial Sloan Kettering Cancer Center, New York

11733

New York Cancer and Blood Specialists, East Setauket

12203

Charité Universitätsmedizin Berlin-Campus Benjamin Franklin Klinik für Hämatologie, Onkologie und Tumorimmunologie, Berlin

12206

New York Oncology Hematology, P.C., Albany

13057

Hematology Oncology Associates of Central New York, P.C., East Syracuse

13125

Helios Klinikum Berlin-Buch, Berlin

13790

Broome Oncology, LLC, Johnson City

14076

Centre François Baclesse Service the Recherche Clinique, Caen

15006

Hospital Teresa Herrera Materno-Infantil (CHUAC), A Coruña

15009

Centro Oncológico de Galicia, A Coruña

15601

Magee-Women's Hospital of UPMC, Pittsburgh

18103

Lehigh Valley Health Network, Allentown

19124

Cancer Treatment Centers of America - Philadelphia, Philadelphia

20132

Ospedale San Raffaele - Medical Oncology Dept., Milan

20141

Istituto Europeo di Oncologia (IEO), Milan

20357

Mammazentrum HH am Krankenhaus Jerusalem, Hamburg

20815

Chevy Chase Health Care Center/ RCCA, Chevy Chase

20850

Maryland Oncology Hematology, P.A., Rockville

21029

Podilskiy Regional Center of Oncology, Vinnytsia

21201

University of Maryland - Greenebaum Comprehensive Cancer Center, Baltimore

21204

GBMC Cancer Center, Baltimore

21339

Staedtisches Klinikum Lueneburg gGmbH Brustzentrum und gynaekologisches Krebszentrum der Frauenklinik, Lüneburg

21702

James M. Stockman Cancer Institute, Frederick

23114

Bon Secours St. Francis, Midlothian

23226

Virginia Cancer Institute, Richmond

23502

Virginia Oncology Associates, Norfolk

24015

UKSH, Campus Kiel Klinik für Gynäkologie und Geburtshilfe, Kiel

27599

University of North Carolina Lineberger Cancer Center, Chapel Hill

28034

Hospital Universitario Ramon y Cajal Servicio de Oncologia, Madrid

IOB_Hospital Ruber Internacional, Madrid

28040

Fundacion Jimenez Diaz, Madrid

Hospital Clinico San Carlos, Madrid

29010

Hospital Universitario Virgen de la Victoria, Málaga

30265

Cancer Treatment Centers of America, Newnan

30607

University Cancer and Blood Center, Athens

32256

Cancer Specialists of North Florida, Jacksonville

32308

Florida Cancer Specialists and Research Institute - Panhandle Region, Tallahassee

32806

Orlando Health, Orlando

33021

Memorial Healthcare System, Hollywood

33176

Miami Cancer Institute, Miami

33324

University of Miami Sylvester Comprehensive Cancer Center / Sylvester at Plantation, Plantation

33401

Florida Cancer Specialists and Research Institute, West Palm Beach

33705

Florida Cancer Specialists and Research Institute, St. Petersburg

33901

Sarah Cannon Research Institute - Florida Cancer Specialists, Fort Myers

34471

Florida Cancer Affiliates - Ocala, Ocala

37044

Centre Hospitalier Regional et Universitaire de Tours CHRU, Tours

37203

Sarah Cannon Research Institute at Tennessee Oncology, Nashville

38138

West Cancer Center, Germantown

39202

Jackson Oncology Associates, Jackson

39401

Forrest General Cancer Center/Hattiesburg Clinic, Hattiesburg

40503

Baptist Health Lexington, Lexington

41122

Centro Oncologico Modenese, Modena

43212

Ohio State University Comprehensive Cancer Center, Stephanie Spielman Comprehensive Breast Center, Columbus

44229

Centre Eugène Marquis, Rennes

46260

American Health Network, Indianapolis

48202

Henry Ford Hospital, Detroit

49102

Dnipropetrovsk City Multifield Clinical Hospital #4, Dnipro

49503

Cancer and Hematology Centers of Western Michigan, Grand Rapids

50009

Hospital Universitario Miguel Servet Paseo Isabel la Catolica 1-3 Edificio de Maternidad, Zaragoza

50048

Kryviy Rih Onkology Dispensary, Kryvyi Rih

50935

St. Elisabeth-Krankenhaus GmbH, Cologne

55407

Virginia Piper Cancer Institute, Allina Health, Minneapolis

56068

InVO - Institut für Versorgungsforschung, Koblenz

58452

St. Elisabethgruppe GmbH Marien Hospital Witten Brustzentrum, Witten

59102

St. Vincent Frontier Cancer Center, Billings

60077

Orchard Healthcare Research, Skokie

60637

University of Chicago Medical Center - Duchossois Center for Advanced Medicine (DCAM), Chicago

61070

"Communal Non-Profit Enterprise Regional Center of Oncology", Kharkiv

63110

Washington University School of Medicine, St Louis

63141

Mercy Hospital St. Louis, David C. Pratt Cancer Center, St Louis

64131

HCA Midwest Health, Kansas City

64804

Mercy Cancer Center, Joplin

67085

Clinique Sainte Anne - Strasbourg Oncologie Liberale, Strasbourg

68046

Oncology Hematology West, P.C. dba Nebraska Cancer Specialists, Papillion

69040

"Communal Institution Zaporizhzhia Regional Clinical Oncological Dispensary", Zaporizhzhia

69310

Hospices Civils de Lyon Sud Oncologie Medicale, Pierre-Bénite

71913

Genesis Cancer Center, Hot Springs

72205

Carti Cancer Center, Little Rock

73120

Mercy Clinic Oncology and Hematology, Oklahoma City

74146

Oklahoma Cancer Specialists and Research Institute, LLC, Tulsa

75230

Texas Oncology - Medical City Dallas, Dallas

75231

Texas Oncology - Dallas Presbyterian Hospital, Dallas

75246

Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas

75701

Hope Cancer Center of East Texas, Tyler

76022

Texas Oncology - Bedford, Bedford

77024

Texas Oncology - Memorial City, Houston

Westside Surgical Hospital and Breast Center, Houston

77030

Oncology Consultants, Houston

79031

Municipal Institution of Lviv Regional Council - Lviv Oncology Regional Treatment Diagnostic Center, Lviv

80228

Rocky Mountain Cancer Center, Lakewood

80366

LMU Klinikum der Universität München Breast Cancer, München

81675

Technische Universität München Klinikum rechts der Isar Klinik und Poliklinik für Frauenheilkunde, München

85224

Ironwood Cancer and Research Centers, Chandler

85338

Cancer Treatment Centers of America - Western Regional Medical Center, Goodyear

85704

Arizona Oncology Associates, P.C. - HOPE, Tucson

87131

New Mexico Cancer Care Alliance - Southwest Gynecology Oncology, Albuquerque

88000

Central City Clinical Hospital, City Oncology Center, Uzhhorod

90024

UCLA Medical Center, Los Angeles

90277

Cancer Care - Torrance Memorial Physician Network, Redondo Beach

90603

Innovative Clinical Research Institute, Whittier

91054

Arzt der Studienzentrale Universitätsklinikum Erlangen, Erlangen

92069

California Cancer Associates for Research and Excellence, San Marcos

92123

Sharp Memorial Hospital, San Diego

92210

Institut Curie - Hopital Rene Huguenin, Saint-Cloud

92705

Cancer Research Collaboration and Breast Link, Santa Ana

92708

Compassionate Care Research Group, Fountain Valley

92835

St. Joseph Heritage Healthcare, Fullerton

93309

CBCC Global Research, Inc., Bakersfield

93401

San Luis Obispo Oncology & Hematology Health Center, San Luis Obispo

93720

California Cancer Associates for Research and Excellence, Fresno

94115

University of California San Francisco - Helen Diller Family Comprehensive Cancer Center, San Francisco

94304

Stanford Cancer Center / Cancer Clinical Trials, Stanford

98004

Overlake Medical Center, Bellevue

98104

Swedish Cancer Center, Seattle

98405

Northwest Medical Specialties, Tacoma

99336

Kadlec Regional Medical Center, Kennewick

198255

State Oncology Clinical Dispansery, Saint Petersburg

92801-1824

Pacific Cancer Medical Center, Anaheim

06810

Western Connecticut Health Network, Danbury

06106

Hartford Healthcare, Hartford

04005

SMHC Cancer Care and Blood Disorders, Biddeford

02215

Dana-Farber Cancer Institute, Boston

08724

New Jersey Hematology Oncology Associates, Brick

08816

Regional Cancer Care Associates, East Brunswick

07451

The Valley Hospital, Ridgewood

07871

Regional Cancer Care Associates, LLC-Sparta, Sparta

Unknown

Mater Cancer Care Centre, South Brisbane

Princess Alexandra Hospital, Woolloongabba

Monash Medical Centre, Clayton

Breast Cancer Research Centre, Nedlands

St. John of God Subiaco Hospital, Perth

Flinders Medical Centre, Bedford Park

Universitätsklinik Onkologie Landeskkrankenhaus, Salzburg

Facharzt für Frauenheilkunde und Geburtshilfe Spezialist für Brustchirurgie und Brustkrebs, Schwaz

AKH-Frauenheilkunde, Vienna

UZ Leuven, Leuven

NH Hospital a.s. Nemocnice Hořovice Onkologie, Hořovice

CHRU J. Minjoz Service Oncologie, Besançon

Military Hospital State Health Center, Budapest

Országos Onkológiai Intézet, Budapest

Semmelweis University, Budapest

Uzsoki utcai kórház, Budapest

Szabolcs Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz, Nyíregyháza

Szpitale Pomorskie Oddział Onkologii i Radioterapii Powstania, Gdynia

Wilmed, Warsaw

Onko-Dent G.L.Slomian, Żory

Federal State Budgetary Institution Research Institute of Oncology named after N.N. Petrov of the Ministry of Health of the Russian Federation, Saint Petersburg

John Hopkins Singapore International Medical Centre, Singapore

National Cancer Centre Singapore, Singapore

National University Hospital, Singapore

Dong-A University Hospital, Busan

Kyungpook National University Hospital, Daegu

National Cancer Center, Goyang

Gachon University Gil Medical Center, Incheon

Asan Medical Center, Seoul

Samsung Medical Center, Seoul

Seoul National University Hospital, Seoul

Severance Hospital, Seoul

Ajou University Hospital, Suwon

St. Vincents Hospital, Suwon

Onkologikoa, San Sebastián

Changhua Christian Hospital, Taichung

Chi Mei Medical Center, Tainan City

National Cheng Kung University Hospital, Tainan City

Koo Foundation Sun Yat-Sen Cancer Center, Taipei

National Taiwan University Hospital, Taipei

Taipei Veterans General Hospital, Taipei

Chang Gung Memorial Hospital Linkou Branch, Taoyuan District

Chulabhorn Hospital, Bangkok

King Chulalongkorn Memorial Hospital, Bangkok

Buddhachinaraj Hospital, Phitsanulok

02930

AZ Klina AUGUSTIJNSLEI, Antwerp

E1C 6Z8

The Moncton Hospital, Moncton

B3H 1V7

QEII Health Sciences Centre - Nova Scotia Cancer Centre, Halifax

M5B 1W8

St. Michael's Hospital, Toronto

H1T 4B3

Hopital Maisonneuve-Rosemont, Montreal

H2X 3E4

Center Hospitalier de Montreal CHUM McPeak Sirois, Montreal

H3T IE2

CIUSSS de Centre-Ouest-de-l'Île-de-Montréal Jewish General Hospital, Montreal

H4J 3J1

McGill University Health Center, Montreal

J1H 5N4

Centre Hospitalier Universitaire de Sherbrooke CIUSSS de lEstrie CHUS patyre, Sherbrooke

G1S 4L8

CHU de Quebec-University Laval, Québec

779 00

Onkologicka Klinika FN Olomouc, Olomouc

128 08

Onkologicka Klinika (Vseobecna Fakultni Nemocnici v Praze ), Prague

150 06

Onkologicka Klinika (Fakultni Nemocnice v Motole), Prague

05100

S.C. Oncologia/Az. Osp.Ra. S Maria Terni, Terni

10-357

Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc, Oddzial Onkologii z Pododdzialem Chemoioterapii, Olsztyn

35-021

Mrukmed, Rzeszów

02-781

Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej Centrum Onkologii-Instytut, Warsaw

06273

Gangnam Severance Hospital, Seoul

08243

Althaia Hospital Sant Joan de Deu, Barcelona

08023

Hospital Quironsalud Barcelona, Barcelona

08035

Hospital Universitari Vall d'Hebron, Barcelona

08908

Institut Catala d'Oncologia, Barcelona

03022

National Cancer Institute, Kyiv

TR1 3LJ

Royal Cornwall Hospital Oncology Trials, Sunrise Centre, Truro

SG14 1LP

Hertford County Hospital, Hertford

SE1 9RT

Cancer Centre, Guy's Hospital, London

NG5 1PB

Nottingham University Hospitals NHS Trust, Nottingham

Sponsors
All Listed Sponsors
lead

Odonate Therapeutics, Inc.

INDUSTRY