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Trial record 1 of 1 for:    03326674
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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03326674
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : June 24, 2019
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

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 identifier (NCT number): NCT03326674

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Contact: Jennifer Baca 910-769-1557
Contact: Jill Krause 810-208-7254

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

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Responsible Party: Odonate Therapeutics, Inc. Identifier: NCT03326674     History of Changes
Other Study ID Numbers: ODO-TE-B301
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: March 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.:
HER2 negative
Hormone Receptor positive
Locally advanced or metastatic breast cancer
Combination of tesetaxel and capecitabine
Metastatic breast cancer
Breast cancer
Central nervous system (CNS) metastases

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents