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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03326674
Recruitment Status : Active, not recruiting
First Posted : October 31, 2017
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
Odonate Therapeutics, Inc.

Brief Summary:
CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel in patients with HER2 negative, HR positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. The primary objective of the study is to compare the efficacy of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone based on progression-free survival (PFS) as assessed by an Independent Radiologic Review Committee (IRC). Approximately 600 patients will be enrolled.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Tesetaxel and Capecitabine Drug: Capecitabine Phase 3

Detailed Description:

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone in patients with HER2 negative, HR positive locally advanced or metastatic breast cancer (LA/MBC) previously treated with a taxane in the neoadjuvant or adjuvant setting. Approximately 600 patients will be enrolled.

Patients randomly assigned to Arm A (tesetaxel plus a reduced dose of capecitabine) will be administered:

  • Tesetaxel (27 mg/m2) orally once every 21 days on Day 1 of each 21-day cycle; and
  • Capecitabine (825 mg/m2) orally twice daily (in the morning and evening after a meal, for a total daily dose of 1,650 mg/m2) beginning with the evening dose on Day 1 through the morning dose on Day 15 of each 21-day cycle.

Patients randomly assigned to Arm B (approved dose of capecitabine alone) will be administered:

  • Capecitabine (1,250 mg/m2) orally twice daily (in the morning and evening after a meal, for a total daily dose of 2,500 mg/m2), beginning with the evening dose on Day 1 through the morning dose on Day 15 of each 21-day cycle

Dose modifications for tesetaxel and/or capecitabine are described in the study protocol.

Patients will be treated until documentation of progressive disease (PD), evidence of unacceptable toxicity, or other decision to discontinue treatment. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in LA/MBC. The primary endpoint is PFS as assessed by an IRC. The secondary efficacy endpoints are overall survival (OS), objective response rate (ORR) as assessed by an IRC, and disease control rate (DCR) as assessed by an IRC.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multinational, Multicenter, Randomized, Phase 3 Study of Tesetaxel Plus a Reduced Dose of Capecitabine Versus Capecitabine Alone in Patients With HER2 Negative, HR Positive, Locally Advanced or Metastatic Breast Cancer Previously Treated With a Taxane
Actual Study Start Date : December 21, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A: Tesetaxel (oral) and capecitabine (oral)
Tesetaxel (27 mg/m2) once every 21 days on Day 1 of each 21-day cycle; and capecitabine (825 mg/m2) twice daily (in the morning and evening after a meal, for a total daily dose of 1,650 mg/m2) beginning with the evening dose on Day 1 through the morning dose on Day 15 of each 21-day cycle
Drug: Tesetaxel and Capecitabine
Tesetaxel plus reduced dose of Capecitabine

Active Comparator: Arm B: Capecitabine (oral)
Capecitabine (1,250 mg/m2) twice daily (in the morning and evening after a meal, for a total daily dose of 2,500 mg/m2) beginning with the evening dose on Day 1 through the morning dose on Day 15 of each 21-day cycle
Drug: Capecitabine
Capecitabine alone at approved dose




Primary Outcome Measures :
  1. PFS [ Time Frame: Approximately 2.5 - 3 years ]
    Progression-free survival as assessed by an IRC


Secondary Outcome Measures :
  1. OS [ Time Frame: Approximately 5 - 5.5 years ]
    Overall Survival

  2. ORR [ Time Frame: Approximately 2.5 - 3 years ]
    Objective response rate as assessed by an IRC

  3. DCR [ Time Frame: Approximately 2.5 - 3 years ]
    Disease control rate as assessed by an IRC

  4. CNS ORR in patients with CNS metastases at baseline [ Time Frame: Approximately 2.5 -3 years ]
    Central nervous system (CNS) ORR as assessed by a CNS IRC

  5. CNS PFS in patients with CNS metastases at baseline or a history of CNS metastases in the intent-to-treat (ITT) population [ Time Frame: Approximately 2.5 -3 years ]
    CNS PFS as assessed by a CNS IRC

  6. CNS OS in patients with CNS metastases at baseline or a history of CNS metastases [ Time Frame: Approximately 2.5 -3 years ]
    CNS OS as assessed by a CNS IRC


Other Outcome Measures:
  1. PRO [ Time Frame: Approximately 2.5 - 3 years ]
    Patient Reported Outcomes - EORTC QLQ-C30 Global Health Status

  2. Incidence of treatment-emergent adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v5.0 [ Time Frame: Approximately 5 - 5.5 years ]
    Adverse Events will be collected at each visit and at unscheduled visits, as clinically indicated

  3. Incidence of clinical laboratory abnormalities as assessed by CBC, serum chemistry and coagulation testing [ Time Frame: Approximately 5 - 5.5 years ]
    Laboratory data will be collected at each visit, and unscheduled visits, as appropriate

  4. Peak plasma concentration (Cmax) of tesetaxel [ Time Frame: Approximately 2.5-3.0 years ]
    Maximum plasma concentration (Cmax) of tesetaxel pre-dose and 0.5 hour post-dose on Day 1 of Cycle 1, 2 and 3 and anytime on Day 15 +/- 2 days of Cycle 1 and 2 (cycles are 21 days)

  5. Area under the plasma concentration versus time curve (AUC) of tesetaxel [ Time Frame: Approximately 2.5-3.0 years ]
    Area under the curve (AUC) of tesetaxel pre-dose and 0.5 hour post-dose on Day 1 of Cycle 1, 2 and 3 and anytime on Day 15 +/- 2 days of Cycle 1 and 2 (cycles are 21 days)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female or male patients at least 18 years of age
  2. Histologically or cytologically confirmed breast cancer
  3. HER2 negative disease based on local testing: American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines should be utilized for assessing HER2 status
  4. HR (estrogen receptor [ER] and/or progesterone receptor [PgR]) positive disease based on local testing: ASCO/CAP guidelines should be utilized for assessing HR status
  5. Measurable disease per RECIST 1.1 or bone-only disease with lytic component

    • Patients with bone-only metastatic cancer must have a lytic or mixed lytic-blastic lesion that can be accurately assessed by computerized tomography (CT) or magnetic resonance imaging (MRI). Patients with bone-only disease without a lytic component (ie, blastic-only metastasis) are not eligible.
    • Known metastases to the CNS are permitted but not required. The following criteria apply:

      • Patients must be neurologically stable and either off corticosteroids or currently treated with a maximum daily dose of 4 mg of dexamethasone (or equivalent), with no increase in corticosteroid dose within 7 days prior to randomization
      • Patients with a history of CNS metastases but with no current evidence of CNS lesions following local therapy are eligible
      • Patients may have CNS metastases that are stable or progressing radiologically
      • Patients with current evidence of leptomeningeal disease are not eligible
      • Patients may have untreated brain metastases or previously treated brain metastases, as long as no immediate local CNS-directed therapy is indicated
      • Any prior whole brain radiation therapy must have been completed > 14 days prior to the date of randomization
      • Prior stereotactic brain radiosurgery is permitted
      • CNS surgical resection must have been completed > 28 days prior to the date of randomization; patient must have complete recovery from surgery
  6. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
  7. Prior therapy (at least one completed dose) with a taxane-containing regimen in the neoadjuvant or adjuvant setting
  8. Prior therapy with an anthracycline-containing regimen in the neoadjuvant, adjuvant, or metastatic setting, where indicated by local regulation or Investigator judgment.
  9. Prior endocrine therapy with or without a CDK 4/6 inhibitor unless endocrine therapy is not indicated (ie, short relapse-free interval while on adjuvant endocrine therapy [endocrine resistance]; rapidly progressing disease/visceral crisis; or endocrine intolerance). Any targeted therapies approved for HER2 negative, HR positive LA/MBC, including everolimus, are permitted as prior therapy. There is no limit to the number of prior endocrine therapies.
  10. Documented disease recurrence or disease progression of: (a) locally advanced disease that is not considered curable by surgery and/or radiation; or (b) metastatic disease.
  11. Adequate hematologic, hepatic, and renal function, as evidenced by:

    • Absolute neutrophil count (ANC) ≥ 1,500/μL without colony-stimulating factor support
    • Platelet count ≥ 100,000/μL
    • Hemoglobin ≥ 10 g/dL without need for hematopoietic growth factor or transfusion support
    • Total bilirubin < 1.5 × upper limit of normal (ULN); does not apply to patients with Gilbert's syndrome
    • Alanine aminotransferase (ALT) < 3 × ULN unless hepatic metastases are present, then < 5 × ULN
    • Aspartate aminotransferase (AST) < 3 × ULN unless hepatic metastases are present, then < 5 × ULN
    • Alkaline phosphatase < 2.5 × ULN unless hepatic metastases are present, then < 5 × ULN
    • Calculated creatinine clearance ≥ 50 mL/min (by Cockcroft-Gault formula or local standard)
    • Serum albumin ≥ 3.0 g/dL
    • Prothrombin time (PT) < 1.5 × ULN or international normalized ratio (INR) < 1.3, and partial thromboplastin time (PTT) < 1.5 × ULN, unless the patient is on a therapeutic anticoagulant
  12. Complete recovery to baseline or Grade 1 per National Cancer Institute (NCI) CTCAE version 5.0 from adverse effects of prior surgery, radiotherapy, endocrine therapy, and other therapy, as applicable, with the exception of Grade 2 alopecia from prior chemotherapy
  13. Ability to swallow an oral solid-dosage form of medication
  14. A negative serum pregnancy test within 7 days prior to the first dose of Study treatment in women of childbearing potential (ie, all women except those who are post menopause for ≥ 1 year or who have a history of hysterectomy or surgical sterilization)
  15. Women of childbearing potential must use an effective, non-hormonal form of contraception from Screening throughout the Treatment Phase and until 70 days after the last dose of study treatment

    • Acceptable methods include: copper intrauterine devices or double barrier methods, including male/female condoms with spermicide and use of contraceptive sponge, cervical cap, or diaphragm

  16. Male patients must use an effective, non-hormonal form of contraception from screening throughout the treatment phase and until 130 days after last dose of study treatment

    • Acceptable methods include male/female condoms with spermicide, or vasectomy with medical confirmation of surgical success

  17. Written informed consent and authorization to use and disclose health information
  18. Ability to comprehend and comply with the requirements of the study

Exclusion Criteria:

  1. Two or more prior chemotherapy regimens for advanced disease
  2. Prior treatment with a taxane in the metastatic setting
  3. Prior treatment with capecitabine at any dose
  4. Current evidence of leptomeningeal disease
  5. Other cancer that required therapy within the preceding 5 years other than adequately treated: (a) non-melanoma skin cancer or in situ cancer; or (b) following approval by the sponsor medical team, other cancer that has a very low risk of interfering with the safety or efficacy endpoints of the study
  6. Known human immunodeficiency virus infection, unless well controlled. Patients who are on an adequate antiviral regimen with no evidence of active infection are considered well controlled.
  7. Active hepatitis B or active hepatitis C infection
  8. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study
  9. Presence of neuropathy > Grade 1 per NCI CTCAE version 5.0
  10. History of hypersensitivity to taxanes; hypersensitivity to the solvent does not preclude patient participation in this study
  11. Anticancer treatment, including endocrine therapy, radiotherapy (except stereotactic brain surgery), chemotherapy, biologic therapy, or therapy in an investigational clinical study, ≤ 14 days prior to the date of randomization
  12. Major surgery ≤ 28 days prior to the date of randomization; patient must have complete recovery from surgery
  13. Less than 2 weeks or 5 plasma half-lives (whichever is greater) since last use of a medication or ingestion of an agent, beverage, or food that is a known clinically relevant strong inhibitor or known clinically relevant inducer of the cytochrome P450 (CYP) 3A pathway (patients should discontinue taking any regularly taken medication that is a strong inhibitor or inducer of the CYP3A pathway)
  14. History of hypersensitivity or unexpected reactions to capecitabine, other fluoropyrimidine agents, or any of their ingredients
  15. Known dihydropyrimidine dehydrogenase (DPD) deficiency. Testing for DPD deficiency must be performed where required by local regulations, using a validated method that is approved by local health authorities.
  16. Pregnant or breastfeeding
  17. If, in the opinion of the Investigator, the patient is deemed unwilling or unable to comply with the requirements of the study
  18. Treatment with brivudine, sorivudine, or its chemically-related analogs ≤ 28 days prior to the date of randomization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03326674


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Locations
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United States, Arizona
Ironwood Cancer and Research Centers
Chandler, Arizona, United States, 85224
Cancer Treatment Centers of America - Western Regional Medical Center
Goodyear, Arizona, United States, 85338
Arizona Oncology Associates, P.C. - HOPE
Tucson, Arizona, United States, 85704
United States, Arkansas
Genesis Cancer Center
Hot Springs, Arkansas, United States, 71913
Carti Cancer Center
Little Rock, Arkansas, United States, 72205
United States, California
Pacific Cancer Medical Center
Anaheim, California, United States, 92801-1824
CBCC Global Research, Inc.
Bakersfield, California, United States, 93309
Compassionate Care Research Group
Fountain Valley, California, United States, 92708
California Cancer Associates for Research and Excellence
Fresno, California, United States, 93720
St. Joseph Heritage Healthcare
Fullerton, California, United States, 92835
UCLA Medical Center
Los Angeles, California, United States, 90024
Cancer Care - Torrance Memorial Physician Network
Redondo Beach, California, United States, 90277
Sharp Memorial Hospital
San Diego, California, United States, 92123
University of California San Francisco - Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94115
San Luis Obispo Oncology & Hematology Health Center
San Luis Obispo, California, United States, 93401
California Cancer Associates for Research and Excellence
San Marcos, California, United States, 92069
Cancer Research Collaboration and Breast Link
Santa Ana, California, United States, 92705
Stanford Cancer Center / Cancer Clinical Trials
Stanford, California, United States, 94304
Innovative Clinical Research Institute
Whittier, California, United States, 90603
United States, Colorado
Rocky Mountain Cancer Center
Lakewood, Colorado, United States, 80228
United States, Connecticut
Western Connecticut Health Network
Danbury, Connecticut, United States, 06810
Hartford Healthcare
Hartford, Connecticut, United States, 06106
United States, Florida
Sarah Cannon Research Institute - Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
Memorial Healthcare System
Hollywood, Florida, United States, 33021
Cancer Specialists of North Florida
Jacksonville, Florida, United States, 32256
Miami Cancer Institute
Miami, Florida, United States, 33176
Florida Cancer Affiliates - Ocala
Ocala, Florida, United States, 34471
Orlando Health
Orlando, Florida, United States, 32806
University of Miami Sylvester Comprehensive Cancer Center / Sylvester at Plantation
Plantation, Florida, United States, 33324
Florida Cancer Specialists and Research Institute
Saint Petersburg, Florida, United States, 33705
Florida Cancer Specialists and Research Institute - Panhandle Region
Tallahassee, Florida, United States, 32308
Florida Cancer Specialists and Research Institute
West Palm Beach, Florida, United States, 33401
United States, Georgia
University Cancer and Blood Center
Athens, Georgia, United States, 30607
Cancer Treatment Centers of America
Newnan, Georgia, United States, 30265
United States, Illinois
University of Chicago Medical Center - Duchossois Center for Advanced Medicine (DCAM)
Chicago, Illinois, United States, 60637
Orchard Healthcare Research
Skokie, Illinois, United States, 60077
United States, Indiana
American Health Network
Indianapolis, Indiana, United States, 46260
United States, Kentucky
Baptist Health Lexington
Lexington, Kentucky, United States, 40503
United States, Maine
SMHC Cancer Care and Blood Disorders
Biddeford, Maine, United States, 04005
United States, Maryland
University of Maryland - Greenebaum Comprehensive Cancer Center
Baltimore, Maryland, United States, 21201
GBMC Cancer Center
Baltimore, Maryland, United States, 21204
Chevy Chase Health Care Center/ RCCA
Chevy Chase, Maryland, United States, 20815
James M. Stockman Cancer Institute
Frederick, Maryland, United States, 21702
Maryland Oncology Hematology, P.A.
Rockville, Maryland, United States, 20850
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Cancer and Hematology Centers of Western Michigan
Grand Rapids, Michigan, United States, 49503
United States, Minnesota
Virginia Piper Cancer Institute, Allina Health
Minneapolis, Minnesota, United States, 55407
United States, Mississippi
Forrest General Cancer Center/Hattiesburg Clinic
Hattiesburg, Mississippi, United States, 39401
Jackson Oncology Associates
Jackson, Mississippi, United States, 39202
United States, Missouri
Mercy Cancer Center
Joplin, Missouri, United States, 64804
HCA Midwest Health
Kansas City, Missouri, United States, 64131
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Mercy Hospital St. Louis, David C. Pratt Cancer Center
Saint Louis, Missouri, United States, 63141
United States, Montana
St. Vincent Frontier Cancer Center
Billings, Montana, United States, 59102
United States, Nebraska
Oncology Hematology West, P.C. dba Nebraska Cancer Specialists
Papillion, Nebraska, United States, 68046
United States, New Jersey
New Jersey Hematology Oncology Associates
Brick, New Jersey, United States, 08724
Regional Cancer Care Associates
East Brunswick, New Jersey, United States, 08816
The Valley Hospital
Ridgewood, New Jersey, United States, 07451
Regional Cancer Care Associates, LLC-Sparta
Sparta, New Jersey, United States, 07871
United States, New Mexico
New Mexico Cancer Care Alliance - Southwest Gynecology Oncology
Albuquerque, New Mexico, United States, 87131
United States, New York
New York Oncology Hematology, P.C.
Albany, New York, United States, 12206
New York Cancer and Blood Specialists
East Setauket, New York, United States, 11733
Hematology Oncology Associates of Central New York, P.C.
East Syracuse, New York, United States, 13057
Broome Oncology, LLC
Johnson City, New York, United States, 13790
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, North Carolina
University of North Carolina Lineberger Cancer Center
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Ohio State University Comprehensive Cancer Center, Stephanie Spielman Comprehensive Breast Center
Columbus, Ohio, United States, 43212
United States, Oklahoma
Mercy Clinic Oncology and Hematology
Oklahoma City, Oklahoma, United States, 73120
Oklahoma Cancer Specialists and Research Institute, LLC
Tulsa, Oklahoma, United States, 74146
United States, Pennsylvania
Lehigh Valley Health Network
Allentown, Pennsylvania, United States, 18103
Cancer Treatment Centers of America - Philadelphia
Philadelphia, Pennsylvania, United States, 19124
Magee-Women's Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15601
United States, Tennessee
West Cancer Center
Germantown, Tennessee, United States, 38138
Sarah Cannon Research Institute at Tennessee Oncology
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology - Bedford
Bedford, Texas, United States, 76022
Texas Oncology - Medical City Dallas
Dallas, Texas, United States, 75230
Texas Oncology - Dallas Presbyterian Hospital
Dallas, Texas, United States, 75231
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Texas Oncology - Memorial City
Houston, Texas, United States, 77024
Westside Surgical Hospital and Breast Center
Houston, Texas, United States, 77024
Oncology Consultants
Houston, Texas, United States, 77030
Hope Cancer Center of East Texas
Tyler, Texas, United States, 75701
United States, Virginia
Bon Secours St. Francis
Midlothian, Virginia, United States, 23114
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Virginia Cancer Institute
Richmond, Virginia, United States, 23226
United States, Washington
Overlake Medical Center
Bellevue, Washington, United States, 98004
Kadlec Regional Medical Center
Kennewick, Washington, United States, 99336
Swedish Cancer Center
Seattle, Washington, United States, 98104
Northwest Medical Specialties
Tacoma, Washington, United States, 98405
Australia, New South Wales
Border Medical Oncology
Albury, New South Wales, Australia, 2640
Sydney Adventist Hospital
Wahroonga, New South Wales, Australia, 2076
Australia, Queensland
Mater Cancer Care Centre
South Brisbane, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia
Peninsula and South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia, 3199
Australia, Western Australia
Breast Cancer Research Centre
Nedlands, Western Australia, Australia
St. John of God Subiaco Hospital
Perth, Western Australia, Australia
Australia
Flinders Medical Centre
Bedford Park, Australia
Austria
Universitätsklinik Onkologie Landeskkrankenhaus
Salzburg, Austria
Facharzt für Frauenheilkunde und Geburtshilfe Spezialist für Brustchirurgie und Brustkrebs
Schwaz, Austria
AKH-Frauenheilkunde
Vienna, Austria
Ludwig Boltzmann Institut fur Klinische Onkologie und Photodynamische Therapie
Wien, Austria, 1130
Belgium
AZ Klina AUGUSTIJNSLEI
Antwerp, Belgium, 02930
Institut Jules Bordet
Brussels, Belgium, 1000
UZA
Edegem, Belgium, 2900
UZ Leuven
Leuven, Belgium
CHC-Sant Joseph Oncology-Hematology
Liège, Belgium, 4000
Canada, New Brunswick
The Moncton Hospital
Moncton, New Brunswick, Canada, E1C 6Z8
Canada, Nova Scotia
QEII Health Sciences Centre - Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Hopital Maisonneuve-Rosemont
Montréal, Quebec, Canada, H1T 4B3
Center Hospitalier de Montreal CHUM McPeak Sirois
Montréal, Quebec, Canada, H2X 3E4
CIUSSS de Centre-Ouest-de-l'Île-de-Montréal Jewish General Hospital
Montréal, Quebec, Canada, H3T IE2
McGill University Health Center
Montréal, Quebec, Canada, H4J 3J1
Centre Hospitalier Universitaire de Sherbrooke CIUSSS de lEstrie CHUS patyre
Sherbrooke, Quebec, Canada, J1H 5N4
Canada
CHU de Quebec-University Laval
Québec, Canada, G1S 4L8
Czechia
NH Hospital a.s. Nemocnice Hořovice Onkologie
Hořovice, Czechia
Onkologicka Klinika FN Olomouc
Olomouc, Czechia, 779 00
Onkologicka Klinika (Vseobecna Fakultni Nemocnici v Praze )
Praha, Czechia, 128 08
Onkologicka Klinika (Fakultni Nemocnice v Motole)
Praha, Czechia, 150 06
France
CHRU J. Minjoz Service Oncologie
Besançon, France
Centre François Baclesse Service the Recherche Clinique
Caen, France, 14076
Hospices Civils de Lyon Sud Oncologie Medicale
Pierre-Benite, France, 69310
Centre Eugène Marquis
Rennes, France, 44229
Institut Curie - Hopital Rene Huguenin
Saint-Cloud, France, 92210
Clinique Sainte Anne - Strasbourg Oncologie Liberale
Strasbourg, France, 67085
Centre Hospitalier Regional et Universitaire de Tours CHRU
Tours, France, 37044
Germany
Arzt der Studienzentrale Universitätsklinikum Erlangen
Erlangen, Berlin, Germany, 91054
St. Elisabeth-Krankenhaus GmbH
Köln, NRW, Germany, 50935
InVO - Institut für Versorgungsforschung
Koblenz, Rhineland-Palatinate, Germany, 56068
St. Elisabethgruppe GmbH Marien Hospital Witten Brustzentrum
Witten, Rhineland-Palatinate, Germany, 58452
Charité Universitätsmedizin Berlin-Campus Benjamin Franklin Klinik für Hämatologie, Onkologie und Tumorimmunologie
Berlin, Germany, 12203
Helios Klinikum Berlin-Buch
Berlin, Germany, 13125
Mammazentrum HH am Krankenhaus Jerusalem
Hamburg, Germany, 20357
UKSH, Campus Kiel Klinik für Gynäkologie und Geburtshilfe
Kiel, Germany, 24015
Staedtisches Klinikum Lueneburg gGmbH Brustzentrum und gynaekologisches Krebszentrum der Frauenklinik
Lueneburg, Germany, 21339
LMU Klinikum der Universität München Breast Cancer
München, Germany, 80366
Technische Universität München Klinikum rechts der Isar Klinik und Poliklinik für Frauenheilkunde
München, Germany, 81675
Hungary
Military Hospital State Health Center
Budapest, Hungary
Országos Onkológiai Intézet
Budapest, Hungary
Semmelweis University
Budapest, Hungary
Uzsoki utcai kórház
Budapest, Hungary
Szabolcs Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz
Nyíregyháza, Hungary
University of Pécs Department of Oncotherapy
Pécs, Hungary, 7624
Italy
Ospedale San Raffaele - Medical Oncology Dept.
Milano, Italy, 20132
Istituto Europeo di Oncologia (IEO)
Milano, Italy, 20141
Centro Oncologico Modenese
Modena, Italy, 41122
S.C. Oncologia/Az. Osp.Ra. S Maria Terni
Terni, Italy, 05100
Korea, Republic of
Dong-A University Hospital
Busan, Korea, Republic of
Kyungpook National University Hospital
Daegu, Korea, Republic of
National Cancer Center
Goyang, Korea, Republic of
Gachon University Gil Medical Center
Incheon, Korea, Republic of
Gangnam Severance Hospital
Seoul, Korea, Republic of, 06273
Asan Medical Center
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Ajou University Hospital
Suwon, Korea, Republic of
St. Vincents Hospital
Suwon, Korea, Republic of
Poland
Szpitale Pomorskie Oddział Onkologii i Radioterapii Powstania
Gdynia, Poland
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc, Oddzial Onkologii z Pododdzialem Chemoioterapii
Olsztyn, Poland, 10-357
Mrukmed
Rzeszów, Poland, 35-021
Wilmed
Warsaw, Poland
Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej Centrum Onkologii-Instytut
Warszawa, Poland, 02-781
Onko-Dent G.L.Slomian
Żory, Poland
Russian Federation
State Oncology Clinical Dispansery
Saint Petersburg, Russian Federation, 198255
Federal State Budgetary Institution Research Institute of Oncology named after N.N. Petrov of the Ministry of Health of the Russian Federation
Saint Petersburg, Russian Federation
Singapore
John Hopkins Singapore International Medical Centre
Singapore, Singapore
National Cancer Centre Singapore
Singapore, Singapore
National University Hospital
Singapore, Singapore
Spain
Onkologikoa
San Sebastián, Gipuzkoa, Spain
Althaia Hospital Sant Joan de Deu
Barcelona, Manresa, Spain, 08243
Hospital Teresa Herrera Materno-Infantil (CHUAC)
A Coruña, Spain, 15006
Hospital Quironsalud Barcelona
Barcelona, Spain, 08023
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Institut Catala d'Oncologia
Barcelona, Spain, 08908
HU San Pedro de Alcantara
Cáceres, Spain, 10003
Centro Oncológico de Galicia
La Coruña, Spain, 15009
Hospital Universitario Ramon y Cajal Servicio de Oncologia
Madrid, Spain, 28034
IOB_Hospital Ruber Internacional
Madrid, Spain, 28034
Fundacion Jimenez Diaz
Madrid, Spain, 28040
Hospital Clinico San Carlos
Madrid, Spain, 28040
Hospital Universitario Virgen de la Victoria
Málaga, Spain, 29010
Hospital Universitario Miguel Servet Paseo Isabel la Catolica 1-3 Edificio de Maternidad
Zaragoza, Spain, 50009
Taiwan
Changhua Christian Hospital
Taichung, Taiwan
Chi Mei Medical Center
Tainan City, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei City, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital Linkou Branch
Taoyuan, Taiwan
Thailand
Chulabhorn Hospital
Bangkok, Thailand
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
Buddhachinaraj Hospital
Phitsanulok, Thailand
Ukraine
Dnipropetrovsk City Multifield Clinical Hospital #4
Dnipro, Ukraine, 49102
Communal Non-Profit Enterprise "Regional Center of Oncology"
Kharkiv, Ukraine, 61070
Kryviy Rih Onkology Dispensary
Kryvyi Rih, Ukraine, 50048
National Cancer Institute
Kyiv, Ukraine, 03022
Municipal Institution of Lviv Regional Council - Lviv Oncology Regional Treatment Diagnostic Center
Lviv, Ukraine, 79031
Podilskiy Regional Center of Oncology
Vinnytsia, Ukraine, 21029
Communal Institution "Zaporizhzhia Regional Clinical Oncological Dispensary"
Zaporizhzhia, Ukraine, 69040
Central City Clinical Hospital, City Oncology Center
Úzhgorod, Ukraine, 88000
United Kingdom
Royal Cornwall Hospital Oncology Trials, Sunrise Centre
Truro, Cornwall, United Kingdom, TR1 3LJ
Hertford County Hospital
Hertford, United Kingdom, SG14 1LP
Cancer Centre, Guy's Hospital
London, United Kingdom, SE1 9RT
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG5 1PB
Sponsors and Collaborators
Odonate Therapeutics, Inc.
Investigators
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Study Director: Joseph O'Connell, MD Odonate Therapeutics, Inc.

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Responsible Party: Odonate Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03326674     History of Changes
Other Study ID Numbers: ODO-TE-B301
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Currently under evaluation by the organization

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Odonate Therapeutics, Inc.:
Tesetaxel
Capecitabine
HER2 negative
Hormone Receptor positive
Locally advanced or metastatic breast cancer
Combination of tesetaxel and capecitabine
Taxanes
Metastatic breast cancer
Breast cancer
Central nervous system (CNS) metastases
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents