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Oncology Clinical Trial Finder

Breast Cancer
Location

Active, not recruiting • Phase III • Stages III, IV • HER2 negative • Post-Menopausal • Brain Metastases present • Interventional

The following is imported from ClinicalTrials.gov:

A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)

The study will evaluate the safety and efficacy of datopotamab deruxtecan (also known as Dato-DXd, DS-1062a), when compared with Investigator's choice of standard of care single-agent chemotherapy (eribulin, capecitabine, vinorelbine, or gemcitabine) in participants with inoperable or metastatic HR-positive, HER2- negative breast cancer who have been treated with one or two prior lines of systemic chemotherapy.

The primary objective of this study will assess the safety and efficacy of datopotamab deruxtecan (Dato-DXd) in participants with inoperable or metastatic HR-positive, HER2-negative breast cancer who have been treated with one or two prior lines of systemic chemotherapy. The study will be stratified based on number of previous lines of chemotherapy (1 vs. 2), prior use of CDK4/6 inhibitors (Yes vs. no) and geographic region of participant (US/Canada/Europe vs. rest of world). This study aims to see if datopotamab deruxtecan allows patients to live longer without their breast cancer getting worse, or simply to live longer, compared to patients receiving standard of care chemotherapy. This study is also looking to see how the treatment and the breast cancer affects patients' quality of life.

Breast Cancer

Study Design

Study type:

Interventional

Estimated enrollment:

733 participants

Actual study start date:

October 18, 2021

Eligibility Criteria

Ages eligible for study:

18 - 999

Sexes eligible for study:

both


Arms and Intervention

  • Dato-DXd

  • Capecitabine

  • Gemcitabine

  • Eribulin

  • Vinorelbine

Trial Information at Site

Last Updated:

Trial Information

ClinicalTrial.gov ID:

Active, not recruiting

Estimated Enrollment:

733

Last Updated:

03/22/2023


Trial Sponsor

AstraZeneca

Study Locations (267)

Research Site

Los Angeles, California, United States

Research Site

San Francisco, California, United States

Research Site

Chicago, Illinois, United States

Research Site

Duarte, California, United States

Research Site

Los Angeles, California, United States

Research Site

Atlanta, Georgia, United States

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