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

NCT03858972 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2021-07-30

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Tesetaxel

Tesetaxel plus reduced dose of capecitabine

DRUG

Capecitabine

Reduced dose of capecitabine

Sponsors & Collaborators

  • Odonate Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Joseph O'Connell, MD · Odonate Therapeutics, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-05
Primary Completion
2021-06-11
Completion
2021-06-11
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03858972 on ClinicalTrials.gov