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Terminated Phase 2 Interventional

Tesetaxel Plus Reduced Dose of Capecitabine in Patients With HER2 Negative, HR Positive, LA/MBC

ClinicalTrials.gov ID: NCT03858972

Public ClinicalTrials.gov record NCT03858972. 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 19, 2026, 2:58 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

Multinational, Multicenter, Phase 2 Study of Tesetaxel Plus a Reduced Dose of Capecitabine in Patients With HER2 Negative, Hormone Receptor Positive, Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Received a Taxane

Brief summary

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

CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel in patients with HER2 negative, HR positive, locally advanced or metastatic breast cancer (LA/MBC) not previously treated with a taxane. The primary objective of the study is to establish the efficacy of tesetaxel plus a reduced dose of capecitabine based on objective response rate (ORR) as assessed by an Independent Radiologic Review Committee (IRC). 152 patients were enrolled.

Study identification

NCT ID
NCT03858972
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 2
Lead sponsor
Odonate Therapeutics, Inc.
Industry
Enrollment
152 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
Feb 5, 2019 (Actual)
Primary completion
Jun 11, 2021 (Actual)
Completion
Jun 11, 2021 (Actual)
Last update posted
Jul 30, 2021

2019 – 2021

United States locations

U.S. sites
9
U.S. states
8
U.S. cities
9
Facility City State ZIP Site status
Innovative Clinical Research Institute Whittier California 90603 —
Rocky Mountain Cancer Center Lakewood Colorado 80228 —
Sarah Cannon Research Institute - Florida Cancer Specialists Fort Myers Florida 33901 —
Florida Cancer Specialists and Research Institute St. Petersburg Florida 33705 —
Dana-Farber Cancer Institute Boston Massachusetts 02215 —
New York Cancer and Blood Specialists East Setauket New York 11733 —
West Cancer Center Germantown Tennessee 38138 —
Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas Texas 75246 —
Virginia Oncology Associates Norfolk Virginia 23502 —

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 16 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03858972, 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 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03858972 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →