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Terminated Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT03326674

Public ClinicalTrials.gov record NCT03326674. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 30, 2026, 4:50 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03326674
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 3
Lead sponsor
Odonate Therapeutics, Inc.
Industry
Enrollment
685 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 21, 2017 (Actual)
Primary completion
Aug 24, 2020 (Actual)
Completion
Jun 28, 2021 (Actual)
Last update posted
Jul 30, 2021

2017 – 2021

United States locations

U.S. sites
90
U.S. states
30
U.S. cities
84
Facility City State ZIP Site status
Ironwood Cancer and Research Centers Chandler Arizona 85224 —
Cancer Treatment Centers of America - Western Regional Medical Center Goodyear Arizona 85338 —
Arizona Oncology Associates, P.C. - HOPE Tucson Arizona 85704 —
Genesis Cancer Center Hot Springs Arkansas 71913 —
Carti Cancer Center Little Rock Arkansas 72205 —
Pacific Cancer Medical Center Anaheim California 92801-1824 —
CBCC Global Research, Inc. Bakersfield California 93309 —
Compassionate Care Research Group Fountain Valley California 92708 —
California Cancer Associates for Research and Excellence Fresno California 93720 —
St. Joseph Heritage Healthcare Fullerton California 92835 —
UCLA Medical Center Los Angeles California 90024 —
Cancer Care - Torrance Memorial Physician Network Redondo Beach California 90277 —
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 —
Stanford Cancer Center / Cancer Clinical Trials Stanford California 94304 —
Innovative Clinical Research Institute Whittier California 90603 —
Rocky Mountain Cancer Center Lakewood Colorado 80228 —
Western Connecticut Health Network Danbury Connecticut 06810 —
Hartford Healthcare Hartford Connecticut 06106 —
Sarah Cannon Research Institute - Florida Cancer Specialists Fort Myers Florida 33901 —
Memorial Healthcare System Hollywood Florida 33021 —
Cancer Specialists of North Florida Jacksonville Florida 32256 —
Miami Cancer Institute Miami Florida 33176 —
Florida Cancer Affiliates - Ocala Ocala Florida 34471 —
Orlando Health Orlando Florida 32806 —
University of Miami Sylvester Comprehensive Cancer Center / Sylvester at Plantation Plantation Florida 33324 —
Florida Cancer Specialists and Research Institute St. Petersburg Florida 33705 —
Florida Cancer Specialists and Research Institute - Panhandle Region Tallahassee Florida 32308 —
Florida Cancer Specialists and Research Institute West Palm Beach Florida 33401 —
University Cancer and Blood Center Athens Georgia 30607 —
Cancer Treatment Centers of America Newnan Georgia 30265 —
University of Chicago Medical Center - Duchossois Center for Advanced Medicine (DCAM) Chicago Illinois 60637 —
Orchard Healthcare Research Skokie Illinois 60077 —
American Health Network Indianapolis Indiana 46260 —
Baptist Health Lexington Lexington Kentucky 40503 —
SMHC Cancer Care and Blood Disorders Biddeford Maine 04005 —
University of Maryland - Greenebaum Comprehensive Cancer Center Baltimore Maryland 21201 —
GBMC Cancer Center Baltimore Maryland 21204 —
Chevy Chase Health Care Center/ RCCA Chevy Chase Maryland 20815 —
James M. Stockman Cancer Institute Frederick Maryland 21702 —
Maryland Oncology Hematology, P.A. Rockville Maryland 20850 —
Dana-Farber Cancer Institute Boston Massachusetts 02215 —
Henry Ford Hospital Detroit Michigan 48202 —
Cancer and Hematology Centers of Western Michigan Grand Rapids Michigan 49503 —
Virginia Piper Cancer Institute, Allina Health Minneapolis Minnesota 55407 —
Forrest General Cancer Center/Hattiesburg Clinic Hattiesburg Mississippi 39401 —
Jackson Oncology Associates Jackson Mississippi 39202 —
Mercy Cancer Center Joplin Missouri 64804 —
HCA Midwest Health Kansas City Missouri 64131 —
Washington University School of Medicine St Louis Missouri 63110 —
Mercy Hospital St. Louis, David C. Pratt Cancer Center St Louis Missouri 63141 —
St. Vincent Frontier Cancer Center Billings Montana 59102 —
Oncology Hematology West, P.C. dba Nebraska Cancer Specialists Papillion Nebraska 68046 —
New Jersey Hematology Oncology Associates Brick New Jersey 08724 —
Regional Cancer Care Associates East Brunswick New Jersey 08816 —
The Valley Hospital Ridgewood New Jersey 07451 —
Regional Cancer Care Associates, LLC-Sparta Sparta New Jersey 07871 —
New Mexico Cancer Care Alliance - Southwest Gynecology Oncology Albuquerque New Mexico 87131 —
New York Oncology Hematology, P.C. Albany New York 12206 —
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 —
Broome Oncology, LLC Johnson City New York 13790 —
Memorial Sloan Kettering Cancer Center New York New York 10065 —
University of North Carolina Lineberger Cancer Center Chapel Hill North Carolina 27599 —
Ohio State University Comprehensive Cancer Center, Stephanie Spielman Comprehensive Breast Center Columbus Ohio 43212 —
Mercy Clinic Oncology and Hematology Oklahoma City Oklahoma 73120 —
Oklahoma Cancer Specialists and Research Institute, LLC Tulsa Oklahoma 74146 —
Lehigh Valley Health Network Allentown Pennsylvania 18103 —
Cancer Treatment Centers of America - Philadelphia Philadelphia Pennsylvania 19124 —
Magee-Women's Hospital of UPMC Pittsburgh Pennsylvania 15601 —
West Cancer Center Germantown Tennessee 38138 —
Sarah Cannon Research Institute at Tennessee Oncology Nashville Tennessee 37203 —
Texas Oncology - Bedford Bedford Texas 76022 —
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 —
Texas Oncology - Memorial City Houston Texas 77024 —
Westside Surgical Hospital and Breast Center Houston Texas 77024 —
Oncology Consultants Houston Texas 77030 —
Hope Cancer Center of East Texas Tyler Texas 75701 —
Bon Secours St. Francis Midlothian Virginia 23114 —
Virginia Oncology Associates Norfolk Virginia 23502 —
Virginia Cancer Institute Richmond Virginia 23226 —
Overlake Medical Center Bellevue Washington 98004 —
Kadlec Regional Medical Center Kennewick Washington 99336 —
Swedish Cancer Center Seattle Washington 98104 —
Northwest Medical Specialties Tacoma Washington 98405 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 117 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03326674, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 30, 2021 · Synced Oct 30, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03326674 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →