Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tesetaxel Plus Reduced Dose of Capecitabine vs. Capecitabine in HER2 Negative, HR Positive, MBC (CONTESSA) (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.
ClinicalTrials.gov Identifier: NCT03326674
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Odonate Therapeutics, Inc.

Brief Summary:

The primary objective is to compare the efficacy of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone in patients with HER2 negative, HR positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting.

Approximately 600 eligible patients will be randomly assigned in a 1:1 ratio to either Arm A (tesetaxel plus a reduced dose of capecitabine) or Arm B (approved dose of capecitabine alone).


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

Detailed Description:

This is a multinational, multicenter, randomized, open-label, parallel group Phase 3 study. The primary objective is to compare the efficacy of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone based on PFS, as assessed by an Independent Radiologic Review Committee (IRC), in patients with HER2 negative, HR positive, LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting.

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 and Capecitabine
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
Drug: Tesetaxel and Capecitabine
Tesetaxel plus reduced dose of Capecitabine vs. approved dose of Capecitabine

Active Comparator: Arm B: Capecitabine
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
Drug: Capecitabine
Capecitabine alone at approved dose




Primary Outcome Measures :
  1. PFS [ Time Frame: Approximately 2.5 - 3 years ]
    Progression Free Survival


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

  3. DCR [ Time Frame: Approximately 2.5 - 3 years ]
    Disease Control Rate

  4. CNS ORR in patients with CNS metastases at Baseline [ Time Frame: Approximately 2.5 -3 years ]
    CNS Objective Response Rate as assessed by the CNS Independent Review Committee (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 Progression Free Survival as assessed by the 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 Overall Survival as assessed by the 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 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] 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) ]
    Maximum plasma concentration (Cmax) of tesetaxel

  5. Area under the plasma concentration versus time curve (AUC) of tesetaxel [ Time Frame: [Approximately 2.5-3.0 years] 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) ]
    Area under the curve (AUC) of tesetaxel



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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 (ER and/or 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 central nervous system (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
    • 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) Common Terminology Criteria for Adverse Events (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 device 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 Medical Monitor, 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


Contacts
Layout table for location contacts
Contact: Stew Kroll 650-576-9679 skroll@odonate.com
Contact: Jill Krause 810-208-7254 jkrause@odonate.com

  Hide Study Locations
Locations
Layout table for location information
United States, Arizona
Ironwood Cancer and Research Centers Recruiting
Chandler, Arizona, United States, 85224
Contact: Lisa Frick, RN    480-398-7671    lisa.frick@ironwoodcrc.com   
Principal Investigator: Sujith Kalmadi, MD         
Cancer Treatment Centers of America - Western Regional Medical Center Recruiting
Goodyear, Arizona, United States, 85338
Contact: Christina Salas, RN,BSN    623-207-3126    christina.salas@ctca-hope.com   
Principal Investigator: Cynthia Lynch, MD         
Arizona Oncology Associates, P.C. - HOPE Recruiting
Tucson, Arizona, United States, 85704
Contact: Stacey Kimbell    520-531-8967    stacey.kimbell@usoncology.com   
Principal Investigator: Rachel Swart, MD         
United States, Arkansas
Genesis Cancer Center Recruiting
Hot Springs, Arkansas, United States, 71913
Contact: Laura Sellers, RN    501-624-7700    lsellers@genesiscancercenter.com   
Principal Investigator: Stephen Divers, MD         
Carti Cancer Center Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Carla Randall, MS, CCRP    501-906-3012    crandall@carti.com   
Principal Investigator: Ryan Hall, MD         
United States, California
Pacific Cancer Medical Center Recruiting
Anaheim, California, United States, 92801-1824
Contact: Elizabeth Brown    714-999-1465 ext 230    elizabethg@pacificcancer.com   
Principal Investigator: Veena Charu, MD         
CBCC Global Research, Inc. Recruiting
Bakersfield, California, United States, 93309
Contact: Lourdes Estrada    661-862-7178    lestrada@cbccusa.com   
Principal Investigator: Shawn Shambaugh, MD         
Compassionate Care Research Group Recruiting
Fountain Valley, California, United States, 92708
Contact: Barbara Lepthien    714-698-0303    barbaral@compcareresearch.com   
Principal Investigator: Haresh Jhangiani, MD         
California Cancer Associates for Research and Excellence Recruiting
Fresno, California, United States, 93720
Contact: Beth C Kimball    760-452-3909 ext 7604523909    bkimball@ccare.com   
Principal Investigator: Amardeep Aulakh, MD         
St. Joseph Heritage Healthcare Recruiting
Fullerton, California, United States, 92835
Contact: Linda Gozar    714-992-3000 ext 3332    linda.gozar@stjoe.org   
Principal Investigator: David Park, MD         
UCLA Medical Center Recruiting
Los Angeles, California, United States, 90024
Contact: Danell Johnson    310-794-3881    danelljohnson@mednet.ucla.edu   
Principal Investigator: John Glaspy, MD         
Cancer Care - Torrence Memorial Physician Network Recruiting
Redondo Beach, California, United States, 90277
Contact: Courtney Steeneken    310-750-3382    courtney.steeneken@tmphysicians.com   
Principal Investigator: Swati Sikaria, MD         
Sharp Memorial Hospital Recruiting
San Diego, California, United States, 92123
Contact: Stephanie Manoff    858-939-5063    stephanie.manoff@sharp.com   
Principal Investigator: Marie Shieh, MD         
University of California San Francisco - Helen Diller Family Comprehensive Cancer Center Recruiting
San Francisco, California, United States, 94115
Contact: Amy DeLuca    415-353-7288    amy.deluca@ucsf.edu   
Principal Investigator: Hope Rugo, MD         
San Luis Obispo Oncology & Hematology Health Center Recruiting
San Luis Obispo, California, United States, 93401
Contact: Lee Walton    805-543-5577      
Principal Investigator: Brian DiCarlo, MD         
California Cancer Associates for Research and Excellence Recruiting
San Marcos, California, United States, 92069
Contact: Beth Kimball, RN-OCN    760-452-3909    bkimball@ccare.com   
Principal Investigator: Michael Kosmo, MD         
Cancer Research Collaboration and Breast Link Recruiting
Santa Ana, California, United States, 92705
Contact: Rosie Blancas, CCRP    562-981-6101 ext 15602    rosie.blancas@cancercollaboration.org   
Principal Investigator: Shlomit Ein-Gal, MD         
Stanford Cancer Center / Cancer Clinical Trials Recruiting
Stanford, California, United States, 94304
Contact: Ann Moffatt    669-233-2816    amoffat@stanford.edu   
Contact: Grace A Castaneda, MPH    650-498-7977    annabelc@stanford.edu   
Principal Investigator: Mark Pegram, MD         
Innovative Clinical Research Institute Recruiting
Whittier, California, United States, 90603
Contact: Ramiz Ibrahim    562-693-4477    ribrahim@icrinstitute.com   
Principal Investigator: Richy Agajanian, MD         
United States, Colorado
Rocky Mountain Cancer Center Recruiting
Lakewood, Colorado, United States, 80228
Contact: Valerie Apodaca    303-430-2700    valerie.apodaca@usoncology.com   
Principal Investigator: Ling Ma, MD         
United States, Connecticut
Western Connecticut Health Network Recruiting
Danbury, Connecticut, United States, 06810
Contact: Pramila Krumholtz, RN    203-739-7997    Pramila.Krumholtz@wchn.org   
Principal Investigator: Wenli Gao, MD         
Hartford Healthcare Recruiting
Hartford, Connecticut, United States, 06106
Contact: Patricia Hinckley    860-972-5752    patricia.hinckley@hhchealth.org   
Principal Investigator: Stacy Nerenstone, MD         
United States, Florida
Sarah Cannon Research Institute - Florida Cancer Specialists Recruiting
Fort Myers, Florida, United States, 33901
Contact: Lynn Bentz    615-329-7613    lbentz@flcancer.com   
Principal Investigator: Fadi Kayali, MD         
Memorial Healthcare System Recruiting
Hollywood, Florida, United States, 33021
Contact: Deneise Francis    954-844-9178    dfrancis@mhs.net   
Principal Investigator: Aurelio Castrellon, MD         
Cancer Specialists of North Florida Recruiting
Jacksonville, Florida, United States, 32256
Contact: Jenni Bachhofer    904-538-4488    research@csnf.us   
Principal Investigator: Maria Valente, MD         
Florida Cancer Affiliates - Ocala Recruiting
Ocala, Florida, United States, 34471
Contact: Erin Sullivan    352-732-4938    erin.sullivan@usoncology.com   
Principal Investigator: Anju Vasudevan, MD         
Orlando Health Recruiting
Orlando, Florida, United States, 32806
Contact: Jennifer Pelley, RN    321-841-4348    jennifer.pelley@orlandohealth.com   
Principal Investigator: Regan Rostofer, MD         
University of Miami Sylvester Comprehensive Cancer Center / Sylvester at Plantation Recruiting
Plantation, Florida, United States, 33324
Contact: Deborah Conte, CCRA    954-210-1171    dmc238@med.miami.edu   
Principal Investigator: Carmen Calfa, MD         
Florida Cancer Specialists and Research Institute Recruiting
Saint Petersburg, Florida, United States, 33705
Contact: Gail Wright, MD    727-216-1143    clinicaltrials@flcancer.com   
Principal Investigator: Gail Wright, MD         
Florida Cancer Specialists and Research Institute - Panhandle Region Recruiting
Tallahassee, Florida, United States, 32308
Contact: Patty Wright, RN    850-877-8166    pwright@flcancer.com   
Principal Investigator: Viralkumar Bhanderi, MD         
Florida Cancer Specialists and Research Institute Recruiting
West Palm Beach, Florida, United States, 33401
Contact: Jennifer Bar Nur    561-472-1696    jbar-nur@flcancer.com   
Principal Investigator: Eric Harris, MD         
United States, Georgia
University Cancer and Blood Center Recruiting
Athens, Georgia, United States, 30607
Contact: Jamie Hodgson    706-353-2990 ext 279    jhodgson@universitycancer.com   
Principal Investigator: Petros Nikolinakos, MD         
Cancer Treatment Centers of America Recruiting
Newnan, Georgia, United States, 30265
Contact: Quin Boynes, B.S., CRC    770-400-7080    quin.boynes@ctca-hope.com   
Principal Investigator: Ricardo Alverez, MD         
United States, Illinois
University of Chicago Medical Center - Duchossois Center for Advanced Medicine (DCAM) Recruiting
Chicago, Illinois, United States, 60637
Contact: Simona Olberkyte    773-834-9774    solberkyte@medicine.bsd.uchicago.edu   
Principal Investigator: Rita Nanda, MD         
Orchard Healthcare Research Recruiting
Skokie, Illinois, United States, 60077
Contact: Joy Jardinico    224-534-7580      
Principal Investigator: Ira Oliff, MD         
United States, Indiana
American Health Network Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Kisha Horan    317-462-1826    Kisha_Horan@ahni.com   
Principal Investigator: Sridhar Bolla, MD         
United States, Kentucky
Baptist Health Lexington Recruiting
Lexington, Kentucky, United States, 40503
Contact: Jeslyn Gill, RN    859-639-8762    jeslyn.gill@bhsi.com   
Principal Investigator: Amy Schell, MD         
United States, Maine
SMHC Cancer Care and Blood Disorders Recruiting
Biddeford, Maine, United States, 04005
Contact: Lisa Lemire    207-396-8228    llemire@mmc.org   
Principal Investigator: Peter Rubin, MD         
New England Cancer Specialists Recruiting
Scarborough, Maine, United States, 04074
Contact: Linda Reinholdsten    207-396-7791    reinhl@newecs.org   
Principal Investigator: Chiara Battelli, MD         
United States, Maryland
University of Maryland - Greenebaum Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: Cheryl Young    410-328-8611    cheryl.young@UMM.edu   
Principal Investigator: Katherine Tkaczuk, MD         
GBMC Cancer Center Recruiting
Baltimore, Maryland, United States, 21204
Contact: Pamela Nikoles, RN,BSN,CCRP    443-849-8089    pnickoles@gbmc.org   
Principal Investigator: Madhu Chaudhry, MD         
Chevy Chase Health Care Center/ RCCA Recruiting
Chevy Chase, Maryland, United States, 20815
Contact: Susan Bendel    301-690-0710    sbendel@cchealthcare.net   
Principal Investigator: Frederick Smith, MD         
James M. Stockman Cancer Institute Recruiting
Frederick, Maryland, United States, 21702
Contact: Hema DiMaggio    301-668-7043    hdimaggio@fmh.org   
Principal Investigator: Brian O'Connor, MD         
Maryland Oncology Hematology, P.A. Recruiting
Rockville, Maryland, United States, 20850
Contact: Melissa Almand    301-424-6231    missy.almand@usoncology.com   
Principal Investigator: Cheryl Aylesworth, MD         
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Breast Cancer Nursing Team    617-632-3478      
Principal Investigator: Sara Tolaney, MD         
United States, Michigan
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Patricia Vallieres, RN    313-916-2438    pvallie9@hfhs.org   
Principal Investigator: Haythem Ali, MD         
Cancer and Hematology Centers of Western Michigan Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Danielle Poliski, CRC    616-954-5550    dpoliski@chcwm.com   
Principal Investigator: Amy Vander Woude, MD         
United States, Minnesota
Virginia Piper Cancer Institute, Allina Health Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Laura Rockwell, RN,OCN    612-863-8716    laura.rockwell@allina.com   
Principal Investigator: Michaela Rsai, MD         
United States, Mississippi
Forrest General Cancer Center/Hattiesburg Clinic Recruiting
Hattiesburg, Mississippi, United States, 39401
Contact: Tammy McBeth    601-288-2495    tmcbeth@forrestgeneral.com   
Principal Investigator: John Hrom, MD         
Jackson Oncology Associates Recruiting
Jackson, Mississippi, United States, 39202
Contact: Teresa Davis, RN    601-355-2485    tdavis@jacksononcology.com   
Principal Investigator: Bobby Graham, MD         
United States, Missouri
Mercy Cancer Center Recruiting
Joplin, Missouri, United States, 64804
Contact: Esmeralda Carrillo    417-556-3074    esmeralda.carrillo@mercy.net   
Principal Investigator: Samir Dalia, MD         
HCA Midwest Health Recruiting
Kansas City, Missouri, United States, 64131
Contact: Jennifer Feeback    816-276-4227      
Principal Investigator: Stephanie Graff, MD         
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Caroline Bumb    314-362-7249      
Principal Investigator: Cynthia Ma, MD         
Mercy Hospital St. Louis, David C. Pratt Cancer Center Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Terri Edwards, BS    314-251-7061    terri.edwards@mercy.net   
Principal Investigator: Bethany Sleckman, MD         
United States, Montana
St. Vincent Frontier Cancer Center Recruiting
Billings, Montana, United States, 59102
Contact: Sabrina Leonhardt    406-238-6684    sabrina.leonhardt@sclhs.net   
Principal Investigator: Patrick Cobb, MD         
United States, Nebraska
Cancer Alliance of Nebraska Recruiting
Omaha, Nebraska, United States, 68106
Contact: Mary Beth Wilwerding    402-991-8070    mwilwerding@canceralliance-ne.org   
Principal Investigator: Nagendra Natarajan, MD         
Oncology Hematology West, P.C. dba Nebraska Cancer Specialists Recruiting
Papillion, Nebraska, United States, 68046
Contact: Megan Meays    402-593-3141    mmeays@nebraskacancer.com   
Principal Investigator: Geetha Palaniappan, MD         
United States, New Jersey
New Jersey Hematology Oncology Associates Recruiting
Brick, New Jersey, United States, 08724
Contact: Lynne North    609-489-3257    lnorth@njhoa.com   
Principal Investigator: Apruv Agrawal, MD         
Regional Cancer Care Associates Recruiting
East Brunswick, New Jersey, United States, 08816
Contact: Eileen Peng, PharmD    732-390-7750    epend@regionalcancercare.org   
Principal Investigator: Edward Licitra, MD         
Valley-Mount Sinai Comprehensive Cancer Care Recruiting
Paramus, New Jersey, United States, 07652
Contact: Alexandra Young    201-634-5439    AYOUNG@Valleyhealth.com   
Principal Investigator: Thomas Rakowski, MD         
Regional Cancer Care Associates, LLC-Sparta Recruiting
Sparta, New Jersey, United States, 07871
Contact: Christine Lyasko, RN    973-729-8801    cylasko@regionalcancercare.org   
Principal Investigator: May Abdo-Matkiwsky, MD         
United States, New Mexico
New Mexico Cancer Care Alliance - Southwest Gynecology Oncology Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Jocelyn Chavez    505-925-0391    jchavez@nmcca.org   
Principal Investigator: Ursa Brown-Glaberman, MD         
United States, New York
New York Oncology Hematology, P.C. Recruiting
Albany, New York, United States, 12206
Contact: Jennifer Moran    518-489-2607    jennifer.moran@usoncology.com   
Principal Investigator: Karen Tedesco, MD         
New York Cancer and Blood Specialists Recruiting
East Setauket, New York, United States, 11733
Contact: Megan Stahl    631-675-5075    mstahl@nycancer.com   
Principal Investigator: Noshir DaCosta, MD         
Hematology Oncology Associates of Central New York, P.C. Recruiting
East Syracuse, New York, United States, 13057
Contact: Kelly Cohn, RN, MS, CCRC    315-472-7504 ext 1356    kcohn@hoacny.com   
Principal Investigator: Anthony Scalzo, MD         
Broome Oncology, LLC Recruiting
Johnson City, New York, United States, 13790
Contact: Carolyn Grausgruber    607-763-8065    cgrausgruber@broomeoncology.com   
Principal Investigator: Ronald P Harris, MD         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Andrew Seidman, MD    646-888-5103    seidmana@mskcc.org   
Principal Investigator: Andrew Seidman, MD         
United States, North Carolina
University of North Carolina Lineberger Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Katie Lansing    984-974-8564    kathryn_lansing@med.unc.edu   
Principal Investigator: Trevor Jolly, MD         
United States, Ohio
Gabrail Cancer Center Research LLC Recruiting
Canton, Ohio, United States, 44718-2566
Contact: Destiny Eblen, CMA    330-492-3345 ext 207    deblen@gabrailcancercenter.com   
Principal Investigator: Nashat Gabrail, MD         
Ohio State University Comprehensive Cancer Center, Stephanie Spielman Comprehensive Breast Center Recruiting
Columbus, Ohio, United States, 43212
Contact: Meghan Wyse, PhD, CCRM    614-685-0380    meghan.wyse@osumc.edu   
Principal Investigator: Nicole Williams, MD         
The Mark H. Zangmeister Cancer Center Recruiting
Columbus, Ohio, United States, 43219
Contact: Kaye Tumeo, RN    614-383-6232    ktumeo@zangcenter.com   
Principal Investigator: Mark Knapp, MD         
United States, Oklahoma
Mercy Clinic Oncology and Hematology Recruiting
Oklahoma City, Oklahoma, United States, 73120
Contact: Sherry Freeland    405-751-4176    sheryl.freeland@mercy.net   
Principal Investigator: Vikki Canfield, MD         
Oklahoma Cancer Specialists and Research Institute, LLC Recruiting
Tulsa, Oklahoma, United States, 74146
Contact: Jan Byerly, RN    918-505-3201 ext 4076    jan.byerly@ocsri.org   
Principal Investigator: Charles Taylor, MD         
United States, Pennsylvania
Lehigh Valley Health Network Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Alisa Brey, RN, BSN, OCN    610-402-1642    Alisa_L.Brey@lvhn.org   
Principal Investigator: Nicolas Lamparella, MD         
Cancer Treatment Centers of America - Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19124
Contact: Jack Medendorp, MS,BSN,RN    215-537-3160    jack.@ctca-hope.com   
Principal Investigator: Sramila Aithal, MD         
Magee-Women's Hospital of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15601
Contact: Shannon Cieply    412-641-2357    cieplysl2@upmc.edu   
Principal Investigator: Vikram Gorantla, MD         
United States, Tennessee
West Cancer Center Recruiting
Germantown, Tennessee, United States, 38138
Contact: Julie Ryder    901-683-0055    jryder@westclinic.com   
Principal Investigator: Lee Schwartzberg, MD         
Sarah Cannon Research Institute at Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
Contact: Luke Moore    615-329-7613    Luke.Moore@SarahCannon.com   
Principal Investigator: Denise Yardley, MD         
United States, Texas
Texas Oncology - Bedford Recruiting
Bedford, Texas, United States, 76022
Contact: Sandra Matthews    817-359-9000    sandy.matthews@usoncology.com   
Principal Investigator: Thomas Anderson, MD         
Texas Oncology - Medical City Dallas Recruiting
Dallas, Texas, United States, 75230
Contact: Sheila Powell    972-566-4291    sheila.powell@usoncology.com   
Principal Investigator: Jay Courtright, MD         
Texas Oncology - Dallas Presbyterian Hospital Recruiting
Dallas, Texas, United States, 75231
Contact: Cathy Barter    214-265-2080    catherine.barter@usoncology.com   
Principal Investigator: Kristi McIntyre, MD         
Texas Oncology - Baylor Charles A. Sammons Cancer Center Recruiting
Dallas, Texas, United States, 75246
Contact: Rita Lopez    214-370-1000    rita.lopez2@usoncology.com   
Principal Investigator: Joyce O'Shaughnessy, MD         
Texas Oncology - Memorial City Recruiting
Houston, Texas, United States, 77024
Contact: Rowena Martinez    713-467-1722    rowena.martinez@usoncology.com   
Principal Investigator: Michelina Cairo, MD         
Westside Surgical Hospital and Breast Center Recruiting
Houston, Texas, United States, 77024
Contact: Marco Morales, MD, MCTM    713-589-6400    mmorales@clinicoreintl.com   
Principal Investigator: Amir Rasheed, MD         
Oncology Consultants Recruiting
Houston, Texas, United States, 77030
Contact: Joel Cisneros    979-942-8898    jcisneros@oncologyconsultants.com   
Principal Investigator: Julio Peguero, MD         
Hope Cancer Center of East Texas Recruiting
Tyler, Texas, United States, 75701
Contact: Amy Allen    903-592-6152    aallen@hopecancertexas.com   
Principal Investigator: Arielle Lee, MD         
United States, Virginia
Bon Secours St. Francis Recruiting
Midlothian, Virginia, United States, 23114
Contact: Mary Williams, RN    804-594-3131    mary_williams7@bshsi.org   
Principal Investigator: William Irvin, MD         
Virginia Oncology Associates Recruiting
Norfolk, Virginia, United States, 23502
Contact: Wendi Gobhardt    757-466-8683    wendi.gobhardt@usoncology.com   
Principal Investigator: Michael Danso, MD         
Virginia Cancer Institute Recruiting
Richmond, Virginia, United States, 23226
Contact: Susan Moore, MSN    804-287-3000 ext 1265    smoore@vacancer.com   
Principal Investigator: James Khatcheressian, MD         
United States, Washington
Overlake Medical Center Recruiting
Bellevue, Washington, United States, 98004
Contact: Pooja Rajeevan    425-635-6081    pooja.rajeevan@overlakehospital.org   
Principal Investigator: Stephen Lemon, MD         
Kadlec Regional Medical Center Recruiting
Kennewick, Washington, United States, 99336
Contact: Paul Alderson    509-783-4637 ext 235    paul.alderson@kadlec.org   
Principal Investigator: Ying Zhuo, MD         
Swedish Cancer Center Recruiting
Seattle, Washington, United States, 98104
Contact: Missy Takahashi    206-386-6911    missy.takahashi@swedish.org   
Principal Investigator: Kristine Rinn, MD         
Northwest Medical Specialties Recruiting
Tacoma, Washington, United States, 98405
Contact: Sharon Thomas    253-200-3211    sthomas@nwmsonline.com   
Principal Investigator: Francis Senecal, MD         
Australia, New South Wales
Border Medical Oncology Recruiting
Albury, New South Wales, Australia, 2640
Contact: Study Coordinator         
Principal Investigator: Kerrie Clarke, MD         
Sydney Adventist Hospital Recruiting
Wahroonga, New South Wales, Australia
Contact: Study Coordinator         
Principal Investigator: Gavin Marx, MD         
Australia, Queensland
Mater Cancer Care Centre Recruiting
South Brisbane, Queensland, Australia
Contact: Study Coordinator         
Principal Investigator: Catherine Shannon, MD         
Princess Alexandra Hospital Recruiting
Woolloongabba, Queensland, Australia
Contact: Study Coordinator         
Principal Investigator: Vladimir Andelkovic, MD         
Australia, Victoria
Monash Medical Centre Recruiting
Clayton, Victoria, Australia
Contact: Study Coordinator         
Principal Investigator: Michelle White, MD         
Peninsula and South Eastern Haematology and Oncology Group Recruiting
Frankston, Victoria, Australia, 3199
Contact: Study Coordinator         
Principal Investigator: Vinod Ganju, MD         
Australia, Western Australia
Breast Cancer Research Centre Recruiting
Nedlands, Western Australia, Australia
Contact: Study Coordinator         
Principal Investigator: Arlene Chan, MD         
St. John of God Subiaco Hospital Recruiting
Perth, Western Australia, Australia
Contact: Study Coordinator         
Principal Investigator: Daphne Tsoi, MD         
Australia
Flinders Medical Centre Recruiting
Bedford Park, Australia
Contact: Study Coordinator         
Principal Investigator: Sina Vatandoust, MD         
Austria
Universitätsklinik Onkologie Landeskkrankenhaus Recruiting
Salzburg, Austria
Contact: Study Coordinator         
Principal Investigator: Richard Greil, Prof. Dr.         
Facharzt für Frauenheilkunde und Geburtshilfe Spezialist für Brustchirurgie und Brustkrebs Recruiting
Schwaz, Austria
Contact: Anja Hubalek, SC    0043 5252 65529    ahubalek@dr-hubalek.at   
Principal Investigator: Hubalek, MD         
AKH-Frauenheilkunde Recruiting
Vienna, Austria
Contact: Ingeborg Brandl    43-1-40400-79870    ingeborg.brandl@meduniwien.ac.at   
Principal Investigator: Christian Singer, Prof. Dr.         
Klinikum Wels-Grieskirchen GmbH Onkologie Recruiting
Wels, Austria
Contact: Katharina Schmied, SC    0043 7242 415 3452    katharina.schmied@klinikum-wegr.at   
Principal Investigator: Sonja Burgstaller, MD         
Ludwig Boltzmann Institut fur Klinische Onkologie und Photodynamische Therapie Recruiting
Wien, Austria
Contact: Elmir Graf    +43 69911943524    hietzing.forschung@gmail.com   
Principal Investigator: Klaus Geissler, MD         
Belgium
AZ Klina AUGUSTIJNSLEI 100 Brasschaat Recruiting
Antwerp, Belgium, 02930
Contact: Sofie Herman, SC    32 3 650 52 73    sofie.herman@klina.be   
Principal Investigator: Didier Verhoeven, MD         
Institut Jules Bordet Recruiting
Brussels, Belgium, 1000
Contact: Andrea Gombos, MD    +32 2 541 72 32    andrea.gombos@bordet.be   
Principal Investigator: Andrea Gombos, MD         
UZA. Wilrijkstraat 10 Recruiting
Edegem, Belgium, 2900
Contact: Astrid Reymer    +3238214365    Astrid.Reymer@uza.be   
Principal Investigator: Sevilay Altintas, MD         
UZ Leuven Recruiting
Leuven, Belgium
Contact: Kevin Punie, MD    +3216346903    kevin.punie@uzleuven.be   
Principal Investigator: Kevin Punie, MD         
CHC-Sant Joseph Oncology-Hematology Recruiting
Liège, Belgium, 4000
Contact: Francoise Kreutz    +32 42248991    francoise.kreutz@chc.be   
Principal Investigator: Maria P Graas, MD         
Canada, New Brunswick
The Moncton Hospital Recruiting
Moncton, New Brunswick, Canada, E1C 6Z8
Contact: Mrudula Avileli    506-857-5669    Mrudula.Avileli@Horizonnb.ca   
Principal Investigator: Maged Salem, MD         
Canada, Nova Scotia
QEII Health Sciences Centre - Nova Scotia Cancer Centre Recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Contact: Kara Bursey, RN    902-473-5679    Kara.bursey@nshealth.ca   
Principal Investigator: Daniel Rayson, MD         
Canada, Ontario
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B1W8
Contact: Amy Skitch    416-864-6060 ext 2084    skitcha@smh.ca   
Principal Investigator: Christine Brezden-Masley, MD         
Canada, Quebec
Hopital Maisonneuve-Rosemont Recruiting
Montréal, Quebec, Canada, H1T 4B3
Contact: Leila I Kaitouni    514-252-3400    leila.idrissi.kaitouni.cemtl@ssss.gouv.qc.ca   
Principal Investigator: Pierre Dube, MD         
McGill University Health Center Recruiting
Montréal, Quebec, Canada, H4J 3J1
Contact: Rosalia Santos    514 934-1934 ext 4432    rosalia.santos@muhc.mcgill.ca   
Principal Investigator: Jamil Asselah, MD         
Centre Hospitalier Universitaire de Sherbrooke CIUSSS de lEstrie CHUS Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Anick Champoux, RN    819-346-1110 ext 12811    anick.champoux.ciussse-chus@ssss.gouv.qc.ca   
Principal Investigator: Michael Pavic, MD         
Canada
CIUSSSde Centre-Ouest-de-l'Île-de-Montréal Jewish General Hospital Recruiting
Montréal, Canada
Contact: Study Coordinator         
Principal Investigator: Lawrence Panasci, MD         
CHU de Quebec-University Laval Recruiting
Québec, Canada, G1S 4L8
Contact: Julie Lemieux, MD    1-418-682-7511    julie.lemieux@crchudequebec.ulaval.ca   
Principal Investigator: Julie Lemieux, MD         
Center Hospitalier de Montreal CHUM McPeak Sirois Recruiting
Québec, Canada, H2X3E4
Contact: Lydia Tkalec    514 890-8000 ext 14186    lydia.tkalec.chum@ssss.gouv.qc.ca   
Principal Investigator: Danielle Charpentier, MD         
Czechia
NH Hospital a.s. Nemocnice Hořovice Onkologie Not yet recruiting
Hořovice, Czechia
Contact: Sarka Liskova, SC    00420 603268132    liskovasarka@seznam.cz   
Principal Investigator: Martin Smakal, MD         
Onkologicka Klinika Recruiting
Olomouc, Czechia, 779 00
Contact: Magda Simkova, SC    00420 588 4433 895    magda.simkova@fnol.cz   
Principal Investigator: Bohuslav Melichar, MD         
Onkologicka Klinika Recruiting
Praha, Czechia, 150 06
Contact: Lucie Prausova, SC    +420 224 434 712    lucie.prausova@fnmotol.cz   
Principal Investigator: Jana Prausova, MD         
Onkologicka Klinika Recruiting
Praha, Czechia
Contact: Eva Kittnarova, SC    + 420 224 966 405    eva.kittnarova@vfn.cz   
Principal Investigator: Lubos Petruzelka, MD         
France
CHRU J. Minoz Recruiting
Besançon, France
Contact: Christiane Guglielmetti-Bargot, SC    33 3 70 63 2005    c1guglielmetti@chu-besancon.fr   
Principal Investigator: Erion Dobi, Prof.         
Centre François Baclesse Service the Recherche Clinique Recruiting
Caen, France, 14076
Contact: Christelle Levy, MD    + 33 231 45 50 15    c.levy@baclesse.unicancer.fr   
Principal Investigator: Christelle F Levy, MD         
Hospices Civils de Lyon Sud Recruiting
Pierre-Benite, France, 69310
Contact: Diane Augu    + 33 478 86 43 24    diane.augu@chu-lyon.fr   
Principal Investigator: Benoit You, MD         
Centre Eugène Marquis Recruiting
Rennes, France, 44229
Contact: Veronique Dieras    332 99 25 32 80    v.dieras@rennes.unicancer.fr   
Principal Investigator: Veronique Dieras         
Institut Curie - Hopital Rene Huguenin Recruiting
Saint-Cloud, France, 92210
Contact: Etienne Brain, MD    33 147 11 18 75    etienne.brain@curie.fr   
Principal Investigator: Etienne C Brain, MD         
Clinique Sainte Anne - Strasbourg Oncologie Liberale Recruiting
Strasbourg, France, 67085
Contact: Christiane Saler, SC    33388453750    csaler@solcrr.org   
Principal Investigator: Louis-Marie Dourthe, MD         
Centre Hospitalier Regional et Universitaire de Tours CHRU Recruiting
Tours, France, 37044
Contact: Helena Vegas, MD    33 2 47 47 99 19    h.vegas@chu-tours.fr   
Principal Investigator: Helena Vegas, MD         
Germany
Arzt der Studienzentrale Universitätsklinikum Erlangen Recruiting
Erlangen, Berlin, Germany, 91054
Contact: Gregor Olmes, SC    49 91318544010    gregor.olmes@uk-erlangen.de   
Principal Investigator: Peter Fasching, Prof.         
St. Elisabethgruppe GmbH Marien Hospital Witten Brustzentrum Recruiting
Witten, Rhineland-Palatinate, Germany, 58452
Contact: Katja Fritz    +492302/1731327    katja.fritz@elisbethgruppe.de   
Principal Investigator: John Hackmann, MD         
Charité Universitätsmedizin Berlin-Campus Benjamin Franklin Klinik für Hämatologie, Onkologie und Tumorimmunologie Recruiting
Berlin, Germany, 12203
Contact: Ulrike Lehmann    49 30 450 513 544    ulrike.lehmann@charite.de   
Principal Investigator: Diana Lüftner, Professor         
Helios Klinikum Berlin-Buch Recruiting
Berlin, Germany
Contact: Michael Untch    +49 30 9401-133395    katja.jugel@helios-kliniken.de   
Principal Investigator: Michael K Untch, Prof.         
Mammazentrum HH am Krankenhaus Jerusalem Recruiting
Hamburg, Germany, 20357
Contact: Silke Kassner    49 0 40 44190 669    kassner@mammazentrum.eu   
Principal Investigator: Christian Schem, MD         
UKSH, Campus Kiel Klinik für Gynäkologie und Geburtshilfe Recruiting
Kiel, Germany, 24015
Contact: Gesa Voss    49 0 431-500-21686    gesa.voss@uksh.de   
Principal Investigator: Christophe Mundhenke, MD         
InVO - Institut für Versorgungsforschung Recruiting
Koblenz, Germany, 56068
Contact: Rudolf Weide, MD    +49 261 9215 6930    weide@invo-koblenz.de   
Principal Investigator: Rudolf Weide, MD         
St. Elisabeth-Krankenhaus GmbH Recruiting
Köln, Germany, 50935
Contact: Sigrun Wolfsturm    +49 0221-4677 2304    sigrun.wolfsturm@hohenlind.de   
Principal Investigator: Claudia Schuhmacher, MD         
Staedtisches Klinikum Lueneburg gGmbH Brustzentrum und gynaekologisches Krebszentrum der Frauenklinik Recruiting
Lueneburg, Germany, 21339
Contact: Katja Zmarlsy    0049-413-177-2379    katja.zmarlsy@klinikum-lueneburg.de   
Principal Investigator: Peter Dall, Prof.Dr.med.         
LMU Klinikum der Universität München Breast Cancer Recruiting
München, Germany, 80366
Contact: Franziska Henze    49 89 4400 77996    ranziska.henze@med.uni-muenchen.de   
Principal Investigator: Rachel Wurstlein, MD         
Technische Universität München Klinikum rechts der Isar Klinik und Poliklinik für Frauenheilkunde Recruiting
München, Germany, 81675
Contact: Daniela Schemmer    49 89 4140 2433    daniela.Schemmer@mri.tum.de   
Principal Investigator: Johannes Ettl, MD         
Hungary
Military Hospital State Health Center Recruiting
Budapest, Hungary
Contact: Gabriella Zahorecz    36 20 5312652    zahoreczg@gmail.com   
Principal Investigator: Zsuzsanna Papai, MD         
Országos Onkológiai Intézet Recruiting
Budapest, Hungary
Contact: Dora Dornyei, SC    0036 20 9997483    dora.dornyei@coordination.hu   
Principal Investigator: Istvan Lang, MD         
Semmelweis University Recruiting
Budapest, Hungary
Contact: Brigitta Meszaros    36 20 825 8846    trial.sote@gmail.com   
Principal Investigator: Magdolna Dank, MD         
Uzsoki utcai kórház Recruiting
Budapest, Hungary
Contact: Tamas Hangyal    36 20 932 2519    tamas.hangyal@coordination.hu   
Principal Investigator: Laszlo Landherr, MD         
Országos Onkológiai Intézet Recruiting
Nyíregyháza, Hungary
Contact: Katalin K Karaszi, SC    0036 304534845    korodine@josa.hu   
Principal Investigator: Jozsef Erfan, MD         
University of Pécs Department of Oncotherapy Recruiting
Pécs, Hungary
Contact: Andrea Szatyor-Jarkovich, SC    + 36202546528    andrea.jarkovich@coordination.hu   
Principal Investigator: Laszlo Mangel, MD         
Italy
Istituto Europeo di Oncologia (IEO) Recruiting
Milano, Italy, 20141
Contact: Marco Colleoni, MD    39 0257489536    marco.colleoni@ieo.it   
Principal Investigator: Marco Colleoni, MD         
Ospedale San Raffaele - Medical Oncology Dept. Recruiting
Milan, Italy, 20132
Contact: Caterina Riccio, SC    +390226432192    riccio.caterina@hsr.it   
Principal Investigator: Luca Gianni, Professor         
Centro Oncologico Modenese Recruiting
Modena, Italy, 41122
Contact: Federico Piacentini, MD    390594222661    federico.piacentini@unimore.it   
Principal Investigator: Federico O Piacentini, MD         
S.C. Oncologia/Az. Osp.Ra. S Maria Terni Recruiting
Terni, Italy, 05100
Contact: Martina Nunzi, MD    390744205631    nunzimartin@liberio.it   
Principal Investigator: Martina Nunzi, MD         
Korea, Republic of
Dong-A University Hospital Recruiting
Busan, Korea, Republic of
Contact: Study Coordinator         
Principal Investigator: Suee Lee, MD, PhD         
Kyungpook National University Hospital Recruiting
Daegu, Korea, Republic of
Contact: Study Coordinator         
Principal Investigator: Yeesoo Chae, MD         
National Cancer Center Recruiting
Goyang, Korea, Republic of
Contact: Study Coordinator         
Principal Investigator: In Hae Park, MD         
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of
Contact: Study Coordinator         
Principal Investigator: Eun Kyung Cho, MD         
Seoul National University Bundang Hospital, Comprehensive Cancer Center Recruiting
Seongnam, Korea, Republic of
Contact: Study Coordinator         
Principal Investigator: Jee Hyun Kim, MD         
Gangnam Severance Hospital Recruiting
Seoul, Korea, Republic of, 06273
Contact: Study Coordinator         
Principal Investigator: Joon Jeong, MD, Prof.         
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Study Coordinator         
Principal Investigator: Sung Bae Kim, MD         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Study Coordinator         
Principal Investigator: Young-Hyuck Im, MD         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Study Coordinator         
Principal Investigator: Seock Ah Im, MD         
Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: Study Coordinator         
Principal Investigator: Joohyuk Sohn, MD, PhD         
Ajou University Hospital Recruiting
Suwon, Korea, Republic of
Contact: Study Coordinator         
Principal Investigator: Seok Yun Kang         
St. Vincents Hospital Recruiting
Suwon, Korea, Republic of
Contact: Study Coordinator         
Principal Investigator: Byoung Yong Shim, MD         
Poland
Szpitale Pomorskie Oddział Onkologii i Radioterapii Powstania Recruiting
Gdynia, Poland
Contact: Marta Kasprzak    + 48 587260187    mkasprzak@szpital-morski.pl   
Principal Investigator: Joanna Pikiel, MD         
Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc, Oddzial Onkologii z Pododdzialem Chemoioterapii Recruiting
Olsztyn, Poland, 10-357
Contact: Dorota Antonowicz    +48 895275979    antonowicz.dorota@gmail.com   
Principal Investigator: Anna Lowczak, MD         
Mrukmed Recruiting
Rzeszów, Poland
Contact: Michal Hapka    + 48 17 850 2470    hapka.mrukmed@gmail.com   
Principal Investigator: Andrzej Mruk, MD         
Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej Centrum Onkologii-Instytut Recruiting
Warsaw, Poland, 02-781
Contact: Elzbieta Sierkowska, SC    +48 509 761 001    esirkowska@coi.pl   
Principal Investigator: Zbigniew Nowecki, MD         
Wilmed Recruiting
Warsaw, Poland
Contact: Magdalena Granat    + 48 22 651 9861    magda.granat@wilmed.pl   
Principal Investigator: Tadeusz Pienkowski, Prof MD         
Onko-Dent G.L.Slomian Recruiting
Żory, Poland
Contact: Urszula Wajzer    + 48 32 469 04 25    salomea@autograf.pl   
Principal Investigator: Grzegorz Slomian, MD         
Russian Federation
State Oncology Clinical Dispansery Recruiting
Saint Petersburg, Russian Federation, 198255
Contact: Ivan Grinev    +78127561842    ivan_grinev@mai.ru   
Principal Investigator: Aleksey Manikhas, MD         
Sub-Investigator: Ivan Grinev, MD         
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
Singapore
John Hopkins Singapore International Medical Centre Recruiting
Singapore, Singapore
Contact: Study Coordinator         
Principal Investigator: Yee Hong Chia, MD         
National Cancer Center Singapore Recruiting
Singapore, Singapore
Contact: Study Coordinator         
Principal Investigator: Elaine Hsuen Lim, MD         
National University Hospital Recruiting
Singapore, Singapore
Contact: Study Coordinator         
Principal Investigator: Soo Chin Lee, MD         
Spain
Onkologikoa Recruiting
San Sebastián, Gipuzkoa, Spain
Contact: Ander Urruticoechea, MD    +34 943 32 83 59 ext +34943328359    anderu@onkologikoa.org   
Contact: Ander Urruticoechea    +34943328359    anderu@onkologikoa.org   
Principal Investigator: Ander Urruticoechea, MD         
Althaia Hospital Sant Joan de Deu Recruiting
Barcelona, Manresa, Spain, 08243
Contact: Elena Cillan, MD    (+34) 938742112    ecillan@althaia.cat   
Principal Investigator: Elena Cillan, MD         
Hospital Teresa Herrera Materno-Infantil (CHUAC) Recruiting
A Coruña, Spain, 15006
Contact: Belen Lopez, SC    +34 981 178000    Belen.Lopez.Cortabitarte@sergas.es   
Principal Investigator: Silvia Antolin Novoa, MD         
Hospital Quironsalud Barcelona Recruiting
Barcelona, Spain, 08023
Contact: Veronica Raquel de Michele    3493281661    vrdemichele@i-crom.net   
Principal Investigator: Jesus Soberino, MD         
Hospital Universitari Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Patricia Gomez, MD    +34 932746000 ext 3799    pgomez@vhio.net   
Principal Investigator: Patricia Gomez, MD         
Institut Catala d'Oncologia Recruiting
Barcelona, Spain, 08908
Contact: Ariadna Iserte, SC    34 932607741    aiserte@iconcologia.net   
Principal Investigator: Agostina Stradella, MD         
HU San Pedro de Alcantara Recruiting
Cáceres, Spain, 10003
Centro Oncológico de Galicia Recruiting
La Coruña, Spain, 15009
Contact: Begoña Uriarte, SC    + 34 981 28 74 99 ext 174    uriarte.b@gmail.com   
Principal Investigator: Manuel Ramos, MD         
Hospital Universitario Ramon y Cajal Servicio de Oncologia Recruiting
Madrid, Spain, 28034
Contact: Javier Cortes, MD    +34 91 336 82 63    jacortes@vhio.net   
Principal Investigator: Javier Cortes, MD         
IOB_Hospital Ruber Internacional Recruiting
Madrid, Spain, 28034
Contact: Esther Holgado, MD    (+34) 913875090/912986250    eholgadomartin@gmail.com   
Principal Investigator: Esther Holgado, MD         
Fundacion Jimenez Diaz Recruiting
Madrid, Spain, 28040
Contact: Berta Martin, SC    +34 915504800 ext 2299    bmartinl@fjd.es   
Principal Investigator: Yann Izarzugaza, MD         
Hospital Clinico San Carlos Recruiting
Madrid, Spain, 28040
Contact: Sandra Merino, SC    +34 913497133    sandra.merino@salud.madrid.org   
Principal Investigator: Jose Angel Garcia Saenz, MD         
Hospital Universitario Virgen de la Victoria Recruiting
Málaga, Spain, 29010
Contact: Elsa Biondi       elsa.biondi@fimabis.org   
Contact: Carmen Manzano    +34 951032508    carmen.manzano@ibima.eu   
Principal Investigator: Begoña Jimenez, MD         
Hospital Universitario Miguel Servet Paseo Isabel la Catolica 1-3 Edificio de Maternidad Recruiting
Zaragoza, Spain, 50009
Contact: Raquel Villanueva, sc    + 34 976765500 ext 3825    rvillanueva.miguelservet@gmail.com   
Principal Investigator: Antonio Anton, MD         
Taiwan
Changhua Christian Hospital Recruiting
Taichung, Taiwan
Contact: Study Coordinator         
Principal Investigator: Shou Tung Chen, MD         
Chi Mei Medical Center Recruiting
Tainan City, Taiwan
Contact: Study Coordinator         
Principal Investigator: Yin Hsun Feng, MD         
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan
Contact: Study Coordinator         
Principal Investigator: Wei Peng Chung, MD         
National Taiwan University Hospital Recruiting
Taipei City, Taiwan
Contact: Study Coordinator         
Principal Investigator: Yen-Shen Lu, MD         
Koo Foundation Sun Yat-Sen Cancer Center Recruiting
Taipei, Taiwan
Contact: Study Coordinator         
Principal Investigator: Mei-Ching Liu, MD         
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan
Contact: Study Coordinator         
Principal Investigator: Ta Chung Chao, MD         
Chang Gung Memorial Hospital Linkou Branch Recruiting
Taoyuan, Taiwan
Contact: Study Coordinator         
Principal Investigator: Shih C Chen, MD         
Thailand
Bumrungrad International Hospital Recruiting
Bangkok, Thailand
Contact: Study Coordinator         
Principal Investigator: Harit Suwanrusme, MD         
Chulabhorn Hospital Recruiting
Bangkok, Thailand
Contact: Study Coordinator         
Principal Investigator: Prakongboon Sungkasubun, MD         
King Chulalongkorn Memorial Hospital Recruiting
Bangkok, Thailand
Contact: Study Coordinator         
Principal Investigator: Napa Parinyanitikul, MD         
Buddhachinaraj Hospital Recruiting
Phitsanulok, Thailand
Contact: Study Coordinator         
Principal Investigator: Manoch Buranachokphaisan, MD         
Ukraine
Dnipropetrovsk City Multifield Clinical Hospital #4 Recruiting
Dnipro, Ukraine, 49102
Contact: Tatiana Nikolaeva, SC    +380663182614    oncology@dsma.dp.ua   
Principal Investigator: Igor Bondarenko, MD, PhD         
Communal Non-Profit Enterprise "Regional Center of Oncology" Recruiting
Kharkiv, Ukraine, 61070
Contact: Vadym Prianikov, MD    +380954205020    pryanikov2012@gmail.com   
Principal Investigator: Vadym Prianikov, MD         
Kryviy Rih Onkology Dispensary Recruiting
Kryvyi Rih, Ukraine, 50048
Contact: Nataliia Lymar, SC    +380675849195    matalyalymar@gmail.com   
Principal Investigator: Hrygoriy Adamchuk, MD         
National Cancer Institute Recruiting
Kyiv, Ukraine, 03022
Contact: Yurii C Ostapenko, MD    +380509095151 ext +380509095151    oncocentr.ua@gmail.com   
Contact: Yurii C Ostapenko    +380509095151 ext +380509095151    oncocentr.ua@gmail.com   
Principal Investigator: Yurii Ostapenko, MD         
Municipal Institution of Lviv Regional Council - Lviv Oncology Regional Treatment Diagnostic Center Recruiting
Lviv, Ukraine, 79031
Contact: Yaroslav Shparyk, Prof.    +380505136507    yshparyk@ukr.net   
Principal Investigator: Yaroslav Shparyk, Prof.         
Podilskiy Regional Center of Oncology Recruiting
Vinnytsia, Ukraine, 21029
Contact: Sergii Shevnia, MD    +380972795074    shevnia1969@gmail.com   
Principal Investigator: Sergii C Shevnia, MD         
Communal Institution "Zaporizhzhia Regional Clinical Oncological Dispensary" Recruiting
Zaporizhzhia, Ukraine, 69040
Contact: Olena Levyk, SC    +380935509213    olenalevyk@gmail.com   
Principal Investigator: Oleksii Kolesnik, MD,PhD         
Central City Clinical Hospital, City Oncology Center Recruiting
Úzhgorod, Ukraine, 88000
Contact: Yevgen Hotko, Dr.    +380505048997    yhotko@gmail.com   
Principal Investigator: Yevgen Hotko, Dr.         
United Kingdom
Royal Cornwall Hospital Oncology Trials, Sunrise Centre Recruiting
Truro, Cornwall, United Kingdom, TR1 3LJ
NWCTC, North Wales Cancer Treatment Centre, Glan Clwyd Hospital Recruiting
Bodelwyddan, Wales, United Kingdom, LL18 5UJ
Contact: Gwyneth Davies    +44 01745 448720 ext 7654    gwyneth.davies3@wales.nhs.uk   
Principal Investigator: Jill Bishop, MD         
Hertford County Hospital Recruiting
Hertford, United Kingdom, SG14 1LP
Contact: Elisabeth Lodge    44 0203 826 2160    ewindmill@nhs.net   
Principal Investigator: Amy Guppy, MD         
Cancer Centre, Guy's Hospital Recruiting
London, United Kingdom, SE1 9RT
Contact: Christopher Bayliss    +44 020 7188 ext 51783    Chris.Bayliss@gstt.nhs.uk   
Principal Investigator: Janine Mansi, MD         
Nottingham University Hospitals NHS Trust Recruiting
Nottingham, United Kingdom
Contact: Jo Wright    +44 (0) 115 9628060    Jo.Wright@nuh.nhs.uk   
Principal Investigator: Sarah Khan         
Sponsors and Collaborators
Odonate Therapeutics, Inc.
Investigators
Layout table for investigator information
Study Director: Joseph O'Connell, MD Odonate Therapeutics, Inc.

Layout table for additonal information
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: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Currently under evaluation by the organization

Layout table for additional information
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:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents