Clinical trial NCT03326674: Tesetaxel Plus Reduced Dose of Capecitabine vs. Capecitabine in HER2 Negative, HR Positive, LA/MBC
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: 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
Lead sponsor: Odonate Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-10-31
Enrollment: 685
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 the Independent Radiologic Review Committee (IRC). 685 patients were enrolled.

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. 685 patients were enrolled, including 674 who received treatment.

Patients randomly assigned to Arm A (tesetaxel plus a reduced dose of capecitabine) are 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) are 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 are 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 efficacy endpoint is PFS as assessed by the IRC. The secondary efficacy endpoints are overall survival (OS), objective response rate (ORR) as assessed by the IRC and disease control rate (DCR) as assessed by the IRC.

Eligibility criteria: Inclusion Criteria:

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

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

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

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

    • Acceptable methods include: copper intrauterine devices or double barrier methods, including male/female condoms with spermicide and use of contraceptive sponge, cervical cap, or diaphragm
16. Male patients must use an effective, non-hormonal form of contraception from screening throughout the treatment phase and until 130 days after last dose of study treatment

    • Acceptable methods include male/female condoms with spermicide, or vasectomy with medical confirmation of surgical success
17. Written informed consent and authorization to use and disclose health information
18. Ability to comprehend and comply with the requirements of the study

Exclusion Criteria:

1. Two or more prior chemotherapy regimens for advanced disease
2. Prior treatment with a taxane in the metastatic setting
3. Prior treatment with capecitabine at any dose
4. Current evidence of leptomeningeal disease
5. Other cancer that required therapy within the preceding 5 years other than adequately treated: (a) non-melanoma skin cancer or in situ cancer; or (b) following approval by the 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 radiosurgery), 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

Primary outcomes:
measure: PFS as assessed by the IRC
timeFrame: Approximately 2.5-3.0 years
Secondary outcomes:
measure: OS
timeFrame: Approximately 5.0-5.5 years
measure: ORR as assessed by the IRC
timeFrame: Approximately 2.5-3.0 years
measure: DCR as assessed by the IRC
timeFrame: Approximately 2.5-3.0 years
measure: Central nervous system (CNS) ORR as assessed by the CNS IRC in patients with CNS metastases at baseline
timeFrame: Approximately 2.5-3.0 years
measure: CNS PFS as assessed by the CNS IRC in patients with CNS metastases at baseline or a history of CNS metastases and in the intent-to-treat (ITT) population
timeFrame: Approximately 2.5-3.0 years
measure: CNS OS in patients with CNS metastases at baseline or a history of CNS metastases
timeFrame: Approximately 2.5-3.0 years
Other outcomes:
measure: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) Global Health Status/QoL
timeFrame: Approximately 2.5-3.0 years
measure: EORTC QLQ-C30 Functional Scales and Symptom Scales/Items
timeFrame: Approximately 2.5-3.0 years
measure: Adverse events, including deaths and other serious adverse events
timeFrame: Approximately 5.0-5.5 years
measure: Incidence of clinical laboratory abnormalities (e.g., CBC, serum chemistry and coagulation testing)
timeFrame: Approximately 5.0-5.5 years
measure: Peak plasma concentration (Cmax) of tesetaxel
timeFrame: Approximately 2.5-3.0 years
measure: Area under the plasma concentration versus time curve (AUC) of tesetaxel
timeFrame: Approximately 2.5-3.0 years
Locations:
city: Chandler
country: United States
facility: Ironwood Cancer and Research Centers
state: Arizona
city: Goodyear
country: United States
facility: Cancer Treatment Centers of America - Western Regional Medical Center
state: Arizona
city: Tucson
country: United States
facility: Arizona Oncology Associates, P.C. - HOPE
state: Arizona
city: Hot Springs
country: United States
facility: Genesis Cancer Center
state: Arkansas
city: Little Rock
country: United States
facility: Carti Cancer Center
state: Arkansas
city: Anaheim
country: United States
facility: Pacific Cancer Medical Center
state: California
city: Bakersfield
country: United States
facility: CBCC Global Research, Inc.
state: California
city: Fountain Valley
country: United States
facility: Compassionate Care Research Group
state: California
city: Fresno
country: United States
facility: California Cancer Associates for Research and Excellence
state: California
city: Fullerton
country: United States
facility: St. Joseph Heritage Healthcare
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Center
state: California
city: Redondo Beach
country: United States
facility: Cancer Care - Torrance Memorial Physician Network
state: California
city: San Diego
country: United States
facility: Sharp Memorial Hospital
state: California
city: San Francisco
country: United States
facility: University of California San Francisco - Helen Diller Family Comprehensive Cancer Center
state: California
city: San Luis Obispo
country: United States
facility: San Luis Obispo Oncology & Hematology Health Center
state: California
city: San Marcos
country: United States
facility: California Cancer Associates for Research and Excellence
state: California
city: Santa Ana
country: United States
facility: Cancer Research Collaboration and Breast Link
state: California
city: Stanford
country: United States
facility: Stanford Cancer Center / Cancer Clinical Trials
state: California
city: Whittier
country: United States
facility: Innovative Clinical Research Institute
state: California
city: Lakewood
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Danbury
country: United States
facility: Western Connecticut Health Network
state: Connecticut
city: Hartford
country: United States
facility: Hartford Healthcare
state: Connecticut
city: Fort Myers
country: United States
facility: Sarah Cannon Research Institute - Florida Cancer Specialists
state: Florida
city: Hollywood
country: United States
facility: Memorial Healthcare System
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida
state: Florida
city: Miami
country: United States
facility: Miami Cancer Institute
state: Florida
city: Ocala
country: United States
facility: Florida Cancer Affiliates - Ocala
state: Florida
city: Orlando
country: United States
facility: Orlando Health
state: Florida
city: Plantation
country: United States
facility: University of Miami Sylvester Comprehensive Cancer Center / Sylvester at Plantation
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists and Research Institute
state: Florida
city: Tallahassee
country: United States
facility: Florida Cancer Specialists and Research Institute - Panhandle Region
state: Florida
city: West Palm Beach
country: United States
facility: Florida Cancer Specialists and Research Institute
state: Florida
city: Athens
country: United States
facility: University Cancer and Blood Center
state: Georgia
city: Newnan
country: United States
facility: Cancer Treatment Centers of America
state: Georgia
city: Chicago
country: United States
facility: University of Chicago Medical Center - Duchossois Center for Advanced Medicine (DCAM)
state: Illinois
city: Skokie
country: United States
facility: Orchard Healthcare Research
state: Illinois
city: Indianapolis
country: United States
facility: American Health Network
state: Indiana
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Biddeford
country: United States
facility: SMHC Cancer Care and Blood Disorders
state: Maine
city: Baltimore
country: United States
facility: University of Maryland - Greenebaum Comprehensive Cancer Center
state: Maryland
city: Baltimore
country: United States
facility: GBMC Cancer Center
state: Maryland
city: Chevy Chase
country: United States
facility: Chevy Chase Health Care Center/ RCCA
state: Maryland
city: Frederick
country: United States
facility: James M. Stockman Cancer Institute
state: Maryland
city: Rockville
country: United States
facility: Maryland Oncology Hematology, P.A.
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Grand Rapids
country: United States
facility: Cancer and Hematology Centers of Western Michigan
state: Michigan
city: Minneapolis
country: United States
facility: Virginia Piper Cancer Institute, Allina Health
state: Minnesota
city: Hattiesburg
country: United States
facility: Forrest General Cancer Center/Hattiesburg Clinic
state: Mississippi
city: Jackson
country: United States
facility: Jackson Oncology Associates
state: Mississippi
city: Joplin
country: United States
facility: Mercy Cancer Center
state: Missouri
city: Kansas City
country: United States
facility: HCA Midwest Health
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital St. Louis, David C. Pratt Cancer Center
state: Missouri
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center
state: Montana
city: Papillion
country: United States
facility: Oncology Hematology West, P.C. dba Nebraska Cancer Specialists
state: Nebraska
city: Brick
country: United States
facility: New Jersey Hematology Oncology Associates
state: New Jersey
city: East Brunswick
country: United States
facility: Regional Cancer Care Associates
state: New Jersey
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Sparta
country: United States
facility: Regional Cancer Care Associates, LLC-Sparta
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Cancer Care Alliance - Southwest Gynecology Oncology
state: New Mexico
city: Albany
country: United States
facility: New York Oncology Hematology, P.C.
state: New York
city: East Setauket
country: United States
facility: New York Cancer and Blood Specialists
state: New York
city: East Syracuse
country: United States
facility: Hematology Oncology Associates of Central New York, P.C.
state: New York
city: Johnson City
country: United States
facility: Broome Oncology, LLC
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Lineberger Cancer Center
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center, Stephanie Spielman Comprehensive Breast Center
state: Ohio
city: Oklahoma City
country: United States
facility: Mercy Clinic Oncology and Hematology
state: Oklahoma
city: Tulsa
country: United States
facility: Oklahoma Cancer Specialists and Research Institute, LLC
state: Oklahoma
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Philadelphia
country: United States
facility: Cancer Treatment Centers of America - Philadelphia
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Magee-Women's Hospital of UPMC
state: Pennsylvania
city: Germantown
country: United States
facility: West Cancer Center
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute at Tennessee Oncology
state: Tennessee
city: Bedford
country: United States
facility: Texas Oncology - Bedford
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Medical City Dallas
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Dallas Presbyterian Hospital
state: Texas
city: Dallas
country: United States
facility: Texas Oncology - Baylor Charles A. Sammons Cancer Center
state: Texas
city: Houston
country: United States
facility: Texas Oncology - Memorial City
state: Texas
city: Houston
country: United States
facility: Westside Surgical Hospital and Breast Center
state: Texas
city: Houston
country: United States
facility: Oncology Consultants
state: Texas
city: Tyler
country: United States
facility: Hope Cancer Center of East Texas
state: Texas
city: Midlothian
country: United States
facility: Bon Secours St. Francis
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Bellevue
country: United States
facility: Overlake Medical Center
state: Washington
city: Kennewick
country: United States
facility: Kadlec Regional Medical Center
state: Washington
city: Seattle
country: United States
facility: Swedish Cancer Center
state: Washington
city: Tacoma
country: United States
facility: Northwest Medical Specialties
state: Washington
city: Albury
country: Australia
facility: Border Medical Oncology
state: New South Wales
city: Wahroonga
country: Australia
facility: Sydney Adventist Hospital
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Cancer Care Centre
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Frankston
country: Australia
facility: Peninsula and South Eastern Haematology and Oncology Group
state: Victoria
city: Nedlands
country: Australia
facility: Breast Cancer Research Centre
state: Western Australia
city: Perth
country: Australia
facility: St. John of God Subiaco Hospital
state: Western Australia
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
city: Salzburg
country: Austria
facility: Universitätsklinik Onkologie Landeskkrankenhaus
city: Schwaz
country: Austria
facility: Facharzt für Frauenheilkunde und Geburtshilfe Spezialist für Brustchirurgie und Brustkrebs
city: Vienna
country: Austria
facility: AKH-Frauenheilkunde
city: Wien
country: Austria
facility: Ludwig Boltzmann Institut fur Klinische Onkologie und Photodynamische Therapie
city: Antwerp
country: Belgium
facility: AZ Klina AUGUSTIJNSLEI
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Edegem
country: Belgium
facility: UZA
city: Leuven
country: Belgium
facility: UZ Leuven
city: Liège
country: Belgium
facility: CHC-Sant Joseph Oncology-Hematology
city: Moncton
country: Canada
facility: The Moncton Hospital
state: New Brunswick
city: Halifax
country: Canada
facility: QEII Health Sciences Centre - Nova Scotia Cancer Centre
state: Nova Scotia
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Montréal
country: Canada
facility: Hopital Maisonneuve-Rosemont
state: Quebec
city: Montréal
country: Canada
facility: Center Hospitalier de Montreal CHUM McPeak Sirois
state: Quebec
city: Montréal
country: Canada
facility: CIUSSS de Centre-Ouest-de-l'Île-de-Montréal Jewish General Hospital
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Center
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke CIUSSS de lEstrie CHUS patyre
state: Quebec
city: Québec
country: Canada
facility: CHU de Quebec-University Laval
city: Hořovice
country: Czechia
facility: NH Hospital a.s. Nemocnice Hořovice Onkologie
city: Olomouc
country: Czechia
facility: Onkologicka Klinika FN Olomouc
city: Praha
country: Czechia
facility: Onkologicka Klinika (Vseobecna Fakultni Nemocnici v Praze )
city: Praha
country: Czechia
facility: Onkologicka Klinika (Fakultni Nemocnice v Motole)
city: Besançon
country: France
facility: CHRU J. Minjoz Service Oncologie
city: Caen
country: France
facility: Centre François Baclesse Service the Recherche Clinique
city: Pierre-Benite
country: France
facility: Hospices Civils de Lyon Sud Oncologie Medicale
city: Rennes
country: France
facility: Centre Eugène Marquis
city: Saint-Cloud
country: France
facility: Institut Curie - Hopital Rene Huguenin
city: Strasbourg
country: France
facility: Clinique Sainte Anne - Strasbourg Oncologie Liberale
city: Tours
country: France
facility: Centre Hospitalier Regional et Universitaire de Tours CHRU
city: Erlangen
country: Germany
facility: Arzt der Studienzentrale Universitätsklinikum Erlangen
state: Berlin
city: Köln
country: Germany
facility: St. Elisabeth-Krankenhaus GmbH
state: NRW
city: Koblenz
country: Germany
facility: InVO - Institut für Versorgungsforschung
state: Rhineland-Palatinate
city: Witten
country: Germany
facility: St. Elisabethgruppe GmbH Marien Hospital Witten Brustzentrum
state: Rhineland-Palatinate
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin-Campus Benjamin Franklin Klinik für Hämatologie, Onkologie und Tumorimmunologie
city: Berlin
country: Germany
facility: Helios Klinikum Berlin-Buch
city: Hamburg
country: Germany
facility: Mammazentrum HH am Krankenhaus Jerusalem
city: Kiel
country: Germany
facility: UKSH, Campus Kiel Klinik für Gynäkologie und Geburtshilfe
city: Lueneburg
country: Germany
facility: Staedtisches Klinikum Lueneburg gGmbH Brustzentrum und gynaekologisches Krebszentrum der Frauenklinik
city: München
country: Germany
facility: LMU Klinikum der Universität München Breast Cancer
city: München
country: Germany
facility: Technische Universität München Klinikum rechts der Isar Klinik und Poliklinik für Frauenheilkunde
city: Budapest
country: Hungary
facility: Military Hospital State Health Center
city: Budapest
country: Hungary
facility: Országos Onkológiai Intézet
city: Budapest
country: Hungary
facility: Semmelweis University
city: Budapest
country: Hungary
facility: Uzsoki utcai kórház
city: Nyíregyháza
country: Hungary
facility: Szabolcs Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz
city: Pécs
country: Hungary
facility: University of Pécs Department of Oncotherapy
city: Milano
country: Italy
facility: Ospedale San Raffaele - Medical Oncology Dept.
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia (IEO)
city: Modena
country: Italy
facility: Centro Oncologico Modenese
city: Terni
country: Italy
facility: S.C. Oncologia/Az. Osp.Ra. S Maria Terni
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Goyang
country: Korea, Republic of
facility: National Cancer Center
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
city: Suwon
country: Korea, Republic of
facility: St. Vincents Hospital
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Oddział Onkologii i Radioterapii Powstania
city: Olsztyn
country: Poland
facility: Samodzielny Publiczny Zespol Gruzlicy i Chorob Pluc, Oddzial Onkologii z Pododdzialem Chemoioterapii
city: Rzeszów
country: Poland
facility: Mrukmed
city: Warsaw
country: Poland
facility: Wilmed
city: Warszawa
country: Poland
facility: Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej Centrum Onkologii-Instytut
city: Żory
country: Poland
facility: Onko-Dent G.L.Slomian
city: Saint Petersburg
country: Russian Federation
facility: State Oncology Clinical Dispansery
city: Saint Petersburg
country: Russian Federation
facility: Federal State Budgetary Institution Research Institute of Oncology named after N.N. Petrov of the Ministry of Health of the Russian Federation
city: Singapore
country: Singapore
facility: John Hopkins Singapore International Medical Centre
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
city: Singapore
country: Singapore
facility: National University Hospital
city: San Sebastián
country: Spain
facility: Onkologikoa
state: Gipuzkoa
city: Barcelona
country: Spain
facility: Althaia Hospital Sant Joan de Deu
state: Manresa
city: A Coruña
country: Spain
facility: Hospital Teresa Herrera Materno-Infantil (CHUAC)
city: Barcelona
country: Spain
facility: Hospital Quironsalud Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Institut Catala d'Oncologia
city: Cáceres
country: Spain
facility: HU San Pedro de Alcantara
city: La Coruña
country: Spain
facility: Centro Oncológico de Galicia
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal Servicio de Oncologia
city: Madrid
country: Spain
facility: IOB_Hospital Ruber Internacional
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet Paseo Isabel la Catolica 1-3 Edificio de Maternidad
city: Taichung
country: Taiwan
facility: Changhua Christian Hospital
city: Tainan City
country: Taiwan
facility: Chi Mei Medical Center
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Koo Foundation Sun Yat-Sen Cancer Center
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital Linkou Branch
city: Bangkok
country: Thailand
facility: Chulabhorn Hospital
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Phitsanulok
country: Thailand
facility: Buddhachinaraj Hospital
city: Dnipro
country: Ukraine
facility: Dnipropetrovsk City Multifield Clinical Hospital #4
city: Kharkiv
country: Ukraine
facility: Communal Non-Profit Enterprise "Regional Center of Oncology"
city: Kryvyi Rih
country: Ukraine
facility: Kryviy Rih Onkology Dispensary
city: Kyiv
country: Ukraine
facility: National Cancer Institute
city: Lviv
country: Ukraine
facility: Municipal Institution of Lviv Regional Council - Lviv Oncology Regional Treatment Diagnostic Center
city: Vinnytsia
country: Ukraine
facility: Podilskiy Regional Center of Oncology
city: Zaporizhzhia
country: Ukraine
facility: Communal Institution "Zaporizhzhia Regional Clinical Oncological Dispensary"
city: Úzhgorod
country: Ukraine
facility: Central City Clinical Hospital, City Oncology Center
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital Oncology Trials, Sunrise Centre
state: Cornwall
city: Hertford
country: United Kingdom
facility: Hertford County Hospital
city: London
country: United Kingdom
facility: Cancer Centre, Guy's Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
Study officials:
affiliation: Odonate Therapeutics, Inc.
name: Joseph O'Connell, MD
role: STUDY_DIRECTOR
References: