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

Principal Investigator

Apurva Pandey

Study Purpose

This study is being carried out to see whether datopotamab-deruxtecan (Dato-DXd) is safe and effective in treating patients with metastatic and/or inoperable breast cancer.

Medical Condition(s)

Hormone receptor-positive (HR+), HER2-negative metastatic and/or inoperable breast cancer

Eligibility Criteria

- age 18 years
- have metastatic and/or inoperable breast cancer that is HR-positive, HER2-negative
- Have already been treated with one or two lines of chemotherapy for metastatic and/or inoperable breast cancer
- Cannot receive, or have had a poor response to, hormone therapy

Age Range

18 - 101

Healthy Volunteers Needed


Duration of Participation

The research study is planned to go on for about 5 years. You will receive the study drugs for as long as your cancer does not get worse or you do not have bad side effects. After you finish receiving the study drugs, we will contact you every 3 months until the study closes to see how you are doing and ask about your cancer.

Minors Included



Knight Cancer Institute Clinical Trials
503 494-1080



Recruitment End


Compensation Provided


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