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Optimal ODO-TE-B301

Status:

Available | Phase III

Official Title:

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) 

Study Purpose:

To compare and assess the efficacy, safety and tolerability of Tesetaxel plus a reduced dose of Capecitabine alone with HER2 negative, HR positive, LA/MBC previously treated with a Taxane in the neoadjuvant or adjuvant setting.

Interventions:

Group 1: Tesetaxel and Capecitabine

Group 2: Capecitabine

Key Participation Requirements:

Gender:

Male or Female

Age:

19 years and older

Diagnosis:

Breast Cancer

Marker Status:

HER2 negative, HR positive

Eligibility:

Measureable disease or bone-only disease

Prior therapy with taxane

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Methodist Health System Trial Code:

Optimal ODO-TE-B301

For more information, visit the U.S. National Library of Medicine clinical trial database.

To learn more about this clinical trial please contact us today!