AzTrials
AzTrials

Breast CancerPhase 3CONTESSANCT03326674

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

A Phase 3 study testing Tesetaxel and Capecitabine and Capecitabine in people with Breast Cancer, run by Odonate Therapeutics, Inc. at 207 sites in 19 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Tesetaxel and Capecitabine and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
685 participants
Where
207 sitesin 19 countries
Study dates
21 Dec 2017to 28 Jun 2021
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female or male patients at least 18 years of age
  • Histologically or cytologically confirmed breast cancer
  • 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
  • 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
  • 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.
Show all 40Show fewer
  • 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
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
  • Prior therapy (at least one completed dose) with a taxane-containing regimen in the neoadjuvant or adjuvant setting
  • Prior therapy with an anthracycline-containing regimen in the neoadjuvant, adjuvant, or metastatic setting, where indicated by local regulation or Investigator judgment.
  • 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.
  • 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.
  • 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
  • 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
  • Ability to swallow an oral solid-dosage form of medication
  • 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)
  • 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
  • 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
  • Written informed consent and authorization to use and disclose health information
  • Ability to comprehend and comply with the requirements of the study

Who cannot join

  • Two or more prior chemotherapy regimens for advanced disease
  • Prior treatment with a taxane in the metastatic setting
  • Prior treatment with capecitabine at any dose
  • Current evidence of leptomeningeal disease
  • 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
  • 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.
Show all 18Show fewer
  • Active hepatitis B or active hepatitis C infection
  • 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
  • Presence of neuropathy > Grade 1 per NCI CTCAE version 5.0
  • History of hypersensitivity to taxanes; hypersensitivity to the solvent does not preclude patient participation in this study
  • 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
  • Major surgery ≤ 28 days prior to the date of randomization; patient must have complete recovery from surgery
  • 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)
  • History of hypersensitivity or unexpected reactions to capecitabine, other fluoropyrimidine agents or any of their ingredients
  • 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.
  • Pregnant or breastfeeding
  • If, in the opinion of the Investigator, the patient is deemed unwilling or unable to comply with the requirements of the study
  • Treatment with brivudine, sorivudine or its chemically-related analogs ≤ 28 days prior to the date of randomization

Trial locations and contacts

207 sites in 19 countries.

207 sites in 19 countries

United States90 sites

  • New York Oncology Hematology, P.C.

    Albany, New York, 12206

  • New Mexico Cancer Care Alliance - Southwest Gynecology Oncology

    Albuquerque, New Mexico, 87131

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18103

  • Pacific Cancer Medical Center

    Anaheim, California, 92801-1824

  • University Cancer and Blood Center

    Athens, Georgia, 30607

  • CBCC Global Research, Inc.

    Bakersfield, California, 93309

  • University of Maryland - Greenebaum Comprehensive Cancer Center

    Baltimore, Maryland, 21201

  • GBMC Cancer Center

    Baltimore, Maryland, 21204

  • Texas Oncology - Bedford

    Bedford, Texas, 76022

  • Overlake Medical Center

    Bellevue, Washington, 98004

  • SMHC Cancer Care and Blood Disorders

    Biddeford, Maine, 04005

  • St. Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • New Jersey Hematology Oncology Associates

    Brick, New Jersey, 08724

  • Ironwood Cancer and Research Centers

    Chandler, Arizona, 85224

  • University of North Carolina Lineberger Cancer Center

    Chapel Hill, North Carolina, 27599

  • Chevy Chase Health Care Center/ RCCA

    Chevy Chase, Maryland, 20815

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

    Chicago, Illinois, 60637

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

    Columbus, Ohio, 43212

  • Texas Oncology - Medical City Dallas

    Dallas, Texas, 75230

  • Texas Oncology - Dallas Presbyterian Hospital

    Dallas, Texas, 75231

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Western Connecticut Health Network

    Danbury, Connecticut, 06810

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Regional Cancer Care Associates

    East Brunswick, New Jersey, 08816

  • New York Cancer and Blood Specialists

    East Setauket, New York, 11733

  • Hematology Oncology Associates of Central New York, P.C.

    East Syracuse, New York, 13057

  • Sarah Cannon Research Institute - Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Compassionate Care Research Group

    Fountain Valley, California, 92708

  • James M. Stockman Cancer Institute

    Frederick, Maryland, 21702

  • California Cancer Associates for Research and Excellence

    Fresno, California, 93720

  • St. Joseph Heritage Healthcare

    Fullerton, California, 92835

  • West Cancer Center

    Germantown, Tennessee, 38138

  • Cancer Treatment Centers of America - Western Regional Medical Center

    Goodyear, Arizona, 85338

  • Cancer and Hematology Centers of Western Michigan

    Grand Rapids, Michigan, 49503

  • Hartford Healthcare

    Hartford, Connecticut, 06106

  • Forrest General Cancer Center/Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • Memorial Healthcare System

    Hollywood, Florida, 33021

  • Genesis Cancer Center

    Hot Springs, Arkansas, 71913

  • Texas Oncology - Memorial City

    Houston, Texas, 77024

  • Westside Surgical Hospital and Breast Center

    Houston, Texas, 77024

  • Oncology Consultants

    Houston, Texas, 77030

  • American Health Network

    Indianapolis, Indiana, 46260

  • Jackson Oncology Associates

    Jackson, Mississippi, 39202

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256

  • Broome Oncology, LLC

    Johnson City, New York, 13790

  • Mercy Cancer Center

    Joplin, Missouri, 64804

  • HCA Midwest Health

    Kansas City, Missouri, 64131

  • Kadlec Regional Medical Center

    Kennewick, Washington, 99336

  • Rocky Mountain Cancer Center

    Lakewood, Colorado, 80228

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • Carti Cancer Center

    Little Rock, Arkansas, 72205

  • UCLA Medical Center

    Los Angeles, California, 90024

  • Miami Cancer Institute

    Miami, Florida, 33176

  • Bon Secours St. Francis

    Midlothian, Virginia, 23114

  • Virginia Piper Cancer Institute, Allina Health

    Minneapolis, Minnesota, 55407

  • Sarah Cannon Research Institute at Tennessee Oncology

    Nashville, Tennessee, 37203

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Cancer Treatment Centers of America

    Newnan, Georgia, 30265

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Florida Cancer Affiliates - Ocala

    Ocala, Florida, 34471

  • Mercy Clinic Oncology and Hematology

    Oklahoma City, Oklahoma, 73120

  • Orlando Health

    Orlando, Florida, 32806

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

    Papillion, Nebraska, 68046

  • Cancer Treatment Centers of America - Philadelphia

    Philadelphia, Pennsylvania, 19124

  • Magee-Women's Hospital of UPMC

    Pittsburgh, Pennsylvania, 15601

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

    Plantation, Florida, 33324

  • Cancer Care - Torrance Memorial Physician Network

    Redondo Beach, California, 90277

  • Virginia Cancer Institute

    Richmond, Virginia, 23226

  • The Valley Hospital

    Ridgewood, New Jersey, 07451

  • Maryland Oncology Hematology, P.A.

    Rockville, Maryland, 20850

  • Sharp Memorial Hospital

    San Diego, California, 92123

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

    San Francisco, California, 94115

  • San Luis Obispo Oncology & Hematology Health Center

    San Luis Obispo, California, 93401

  • California Cancer Associates for Research and Excellence

    San Marcos, California, 92069

  • Cancer Research Collaboration and Breast Link

    Santa Ana, California, 92705

  • Swedish Cancer Center

    Seattle, Washington, 98104

  • Orchard Healthcare Research

    Skokie, Illinois, 60077

  • Regional Cancer Care Associates, LLC-Sparta

    Sparta, New Jersey, 07871

  • Washington University School of Medicine

    St Louis, Missouri, 63110

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

    St Louis, Missouri, 63141

  • Florida Cancer Specialists and Research Institute

    St. Petersburg, Florida, 33705

  • Stanford Cancer Center / Cancer Clinical Trials

    Stanford, California, 94304

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

  • Florida Cancer Specialists and Research Institute - Panhandle Region

    Tallahassee, Florida, 32308

  • Arizona Oncology Associates, P.C. - HOPE

    Tucson, Arizona, 85704

  • Oklahoma Cancer Specialists and Research Institute, LLC

    Tulsa, Oklahoma, 74146

  • Hope Cancer Center of East Texas

    Tyler, Texas, 75701

  • Florida Cancer Specialists and Research Institute

    West Palm Beach, Florida, 33401

  • Innovative Clinical Research Institute

    Whittier, California, 90603

Other trials in United States

Spain14 sites

  • Hospital Teresa Herrera Materno-Infantil (CHUAC)

    A Coruña, 15006

  • Centro Oncológico de Galicia

    A Coruña, 15009

  • Althaia Hospital Sant Joan de Deu

    Barcelona, Manresa, 08243

  • Hospital Quironsalud Barcelona

    Barcelona, 08023

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Institut Catala d'Oncologia

    Barcelona, 08908

  • HU San Pedro de Alcantara

    Cáceres, 10003

  • Hospital Universitario Ramon y Cajal Servicio de Oncologia

    Madrid, 28034

  • IOB_Hospital Ruber Internacional

    Madrid, 28034

  • Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • Onkologikoa

    San Sebastián, Gipuzkoa

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

    Zaragoza, 50009

Other trials in Spain

Germany11 sites

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

    Berlin, 12203

  • Helios Klinikum Berlin-Buch

    Berlin, 13125

  • St. Elisabeth-Krankenhaus GmbH

    Cologne, North Rhine-Westphalia, 50935

  • Arzt der Studienzentrale Universitätsklinikum Erlangen

    Erlangen, State of Berlin, 91054

  • Mammazentrum HH am Krankenhaus Jerusalem

    Hamburg, 20357

  • UKSH, Campus Kiel Klinik für Gynäkologie und Geburtshilfe

    Kiel, 24015

  • InVO - Institut für Versorgungsforschung

    Koblenz, Rhineland-Palatinate, 56068

  • Staedtisches Klinikum Lueneburg gGmbH Brustzentrum und gynaekologisches Krebszentrum der Frauenklinik

    Lüneburg, 21339

  • LMU Klinikum der Universität München Breast Cancer

    München, 80366

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

    München, 81675

  • St. Elisabethgruppe GmbH Marien Hospital Witten Brustzentrum

    Witten, Rhineland-Palatinate, 58452

Other trials in Germany

South Korea11 sites

  • Dong-A University Hospital

    Busan

  • Kyungpook National University Hospital

    Daegu

  • National Cancer Center

    Goyang

  • Gachon University Gil Medical Center

    Incheon

  • Gangnam Severance Hospital

    Seoul, 06273

  • Asan Medical Center

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul National University Hospital

    Seoul

  • Severance Hospital

    Seoul

  • Ajou University Hospital

    Suwon

  • St. Vincents Hospital

    Suwon

Other trials in South Korea

Australia9 sites

  • Border Medical Oncology

    Albury, New South Wales, 2640

  • Flinders Medical Centre

    Bedford Park

  • Monash Medical Centre

    Clayton, Victoria

  • Peninsula and South Eastern Haematology and Oncology Group

    Frankston, Victoria, 3199

  • Breast Cancer Research Centre

    Nedlands, Western Australia

  • St. John of God Subiaco Hospital

    Perth, Western Australia

  • Mater Cancer Care Centre

    South Brisbane, Queensland

  • Sydney Adventist Hospital

    Wahroonga, New South Wales, 2076

  • Princess Alexandra Hospital

    Woolloongabba, Queensland

Other trials in Australia

Canada9 sites

  • QEII Health Sciences Centre - Nova Scotia Cancer Centre

    Halifax, Nova Scotia, B3H 1V7

  • The Moncton Hospital

    Moncton, New Brunswick, E1C 6Z8

  • Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 4B3

  • Center Hospitalier de Montreal CHUM McPeak Sirois

    Montreal, Quebec, H2X 3E4

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

    Montreal, Quebec, H3T IE2

  • McGill University Health Center

    Montreal, Quebec, H4J 3J1

  • CHU de Quebec-University Laval

    Québec, G1S 4L8

  • Centre Hospitalier Universitaire de Sherbrooke CIUSSS de lEstrie CHUS patyre

    Sherbrooke, Quebec, J1H 5N4

  • St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

Other trials in Canada

Ukraine8 sites

  • Dnipropetrovsk City Multifield Clinical Hospital #4

    Dnipro, 49102

  • Communal Non-Profit Enterprise "Regional Center of Oncology"

    Kharkiv, 61070

  • Kryviy Rih Onkology Dispensary

    Kryvyi Rih, 50048

  • National Cancer Institute

    Kyiv, 03022

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

    Lviv, 79031

  • Central City Clinical Hospital, City Oncology Center

    Uzhhorod, 88000

  • Podilskiy Regional Center of Oncology

    Vinnytsia, 21029

  • Communal Institution "Zaporizhzhia Regional Clinical Oncological Dispensary"

    Zaporizhzhya, 69040

Other trials in Ukraine

France7 sites

  • CHRU J. Minjoz Service Oncologie

    Besançon

  • Centre François Baclesse Service the Recherche Clinique

    Caen, 14076

  • Hospices Civils de Lyon Sud Oncologie Medicale

    Pierre-Bénite, 69310

  • Centre Eugène Marquis

    Rennes, 44229

  • Institut Curie - Hopital Rene Huguenin

    Saint-Cloud, 92210

  • Clinique Sainte Anne - Strasbourg Oncologie Liberale

    Strasbourg, 67085

  • Centre Hospitalier Regional et Universitaire de Tours CHRU

    Tours, 37044

Other trials in France

Taiwan7 sites

  • Changhua Christian Hospital

    Taichung

  • Chi Mei Medical Center

    Tainan

  • National Cheng Kung University Hospital

    Tainan

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei

  • National Taiwan University Hospital

    Taipei

  • Taipei Veterans General Hospital

    Taipei

  • Chang Gung Memorial Hospital Linkou Branch

    Taoyuan

Other trials in Taiwan

Hungary6 sites

  • Military Hospital State Health Center

    Budapest

  • Országos Onkológiai Intézet

    Budapest

  • Semmelweis University

    Budapest

  • Uzsoki utcai kórház

    Budapest

  • Szabolcs Szatmar Bereg Megyei Korhazak Es Egyetemi Oktatokorhaz

    Nyíregyháza

  • University of Pécs Department of Oncotherapy

    Pécs, 7624

Other trials in Hungary

Poland6 sites

  • Szpitale Pomorskie Oddział Onkologii i Radioterapii Powstania

    Gdynia

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

    Olsztyn, 10-357

  • Mrukmed

    Rzeszów, 35-021

  • Klinika Nowotworów Piersi i Chirurgii Rekonstrukcyjnej Centrum Onkologii-Instytut

    Warsaw, 02-781

  • Wilmed

    Warsaw

  • Onko-Dent G.L.Slomian

    Żory

Other trials in Poland

Belgium5 sites

  • AZ Klina AUGUSTIJNSLEI

    Antwerp, 02930

  • Institut Jules Bordet

    Brussels, 1000

  • UZA

    Edegem, 2900

  • UZ Leuven

    Leuven

  • CHC-Sant Joseph Oncology-Hematology

    Liège, 4000

Other trials in Belgium

Austria4 sites

  • Universitätsklinik Onkologie Landeskkrankenhaus

    Salzburg

  • Facharzt für Frauenheilkunde und Geburtshilfe Spezialist für Brustchirurgie und Brustkrebs

    Schwaz

  • Ludwig Boltzmann Institut fur Klinische Onkologie und Photodynamische Therapie

    Vienna, 1130

  • AKH-Frauenheilkunde

    Vienna

Other trials in Austria

Czechia4 sites

  • NH Hospital a.s. Nemocnice Hořovice Onkologie

    Hořovice

  • Onkologicka Klinika FN Olomouc

    Olomouc, 779 00

  • Onkologicka Klinika (Vseobecna Fakultni Nemocnici v Praze )

    Prague, 128 08

  • Onkologicka Klinika (Fakultni Nemocnice v Motole)

    Prague, 150 06

Other trials in Czechia

Italy4 sites

  • Ospedale San Raffaele - Medical Oncology Dept.

    Milan, 20132

  • Istituto Europeo di Oncologia (IEO)

    Milan, 20141

  • Centro Oncologico Modenese

    Modena, 41122

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

    Terni, 05100

Other trials in Italy

United Kingdom4 sites

  • Hertford County Hospital

    Hertford, SG14 1LP

  • Cancer Centre, Guy's Hospital

    London, SE1 9RT

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB

  • Royal Cornwall Hospital Oncology Trials, Sunrise Centre

    Truro, Cornwall, TR1 3LJ

Other trials in United Kingdom

Singapore3 sites

  • John Hopkins Singapore International Medical Centre

    Singapore

  • National Cancer Centre Singapore

    Singapore

  • National University Hospital

    Singapore

Other trials in Singapore

Thailand3 sites

  • Chulabhorn Hospital

    Bangkok

  • King Chulalongkorn Memorial Hospital

    Bangkok

  • Buddhachinaraj Hospital

    Phitsanulok

Other trials in Thailand

Russia2 sites

  • State Oncology Clinical Dispansery

    Saint Petersburg, 198255

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

    Saint Petersburg

Other trials in Russia

About this study

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

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.

Read the 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.

Conditions
Breast Cancer
Being tested
Tesetaxel and Capecitabine, Capecitabine
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
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tesetaxel and CapecitabineDrug

    Tesetaxel plus reduced dose of Capecitabine

  • CapecitabineDrug

    Capecitabine alone at approved dose

Study groups in NCT03326674
Study groupRoleWhat they receive
Arm A: Tesetaxel (oral) and capecitabine (oral)ExperimentalTesetaxel (27 mg/m2) once every 21 days on Day 1 of each 21-day cycle; and capecitabine (825 mg/m2) twice daily (in the morning and evening after a meal, for a total daily dose of 1,650 mg/m2) beginning with the evening dose on Day 1 through the morning dose on Day 15 of each 21-day cycle
Receives: Drug: Tesetaxel and Capecitabine
Arm B: Capecitabine (oral)Active comparatorCapecitabine (1,250 mg/m2) twice daily (in the morning and evening after a meal, for a total daily dose of 2,500 mg/m2) beginning with the evening dose on Day 1 through the morning dose on Day 15 of each 21-day cycle
Receives: Drug: Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS as assessed by the IRC

    Measured: Approximately 2.5-3.0 years

Secondary outcomes (6)

  1. OS

    Measured: Approximately 5.0-5.5 years

  2. ORR as assessed by the IRC

    Measured: Approximately 2.5-3.0 years

  3. DCR as assessed by the IRC

    Measured: Approximately 2.5-3.0 years

  4. Central nervous system (CNS) ORR as assessed by the CNS IRC in patients with CNS metastases at baseline

    Measured: Approximately 2.5-3.0 years

  5. 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

    Measured: Approximately 2.5-3.0 years

  6. CNS OS in patients with CNS metastases at baseline or a history of CNS metastases

    Measured: Approximately 2.5-3.0 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2017
  2. Study start21 Dec 2017
  3. Primary completion24 Aug 2020
  4. Study completion28 Jun 2021

Why it stopped: The Sponsor has discontinued the development of tesetaxel

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
685 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03326674
Sponsor's protocol ID
ODO-TE-B301
Acronym
CONTESSA
Status last verified
Jul 2021
First submitted
13 Oct 2017
Last updated
30 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: Currently under evaluation by the organization

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tesetaxel and Capecitabine and Capecitabine in people with Breast Cancer, run by Odonate Therapeutics, Inc. at 207 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 40 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 207 sites in United States, Spain, Germany, South Korea, Australia and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The Sponsor has discontinued the development of tesetaxel). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS as assessed by the IRC (time frame: Approximately 2.5-3.0 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03326674.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in