TROPION-Breast01: A Study of Dato-DXd Versus Investigator's Choice Chemotherapy in Inoperable or Metastatic Hormone Receptor-positive, HER2 negative Breast Cancer

About this Study

The purpose of this study is to learn more about the effectiveness of the investigational non-FDA approved drug datopotamab deruxtecan (also known as Dato-DXd) compared to treatment with a single standard FDA approved chemotherapy that will be selected by your doctor and to further determine the safety of Dato-DXd in participants with inoperable or metastatic hormone receptor positive, HER2 negative breast cancer

Sponsor Protocol ID:D9268C00001
IRB Number:2022-1012
Closed for Enrollment
Phase 3
Eligibility Criteria
18 years old
Both Male and Female

Inclusion Criteria
  • Must be greater than 18 years of age
  • Male or female
  • Inoperable or metastatic hormone receptor positive, HER2 negative breast cancer
  • Progressed on or not suitable for endocrine therapy per investigator assessment, and treated with 1 to 2 lines of prior standard of care chemotherapy in the operable/metastatic setting
  • Eligible for one of the chemotherapy options listed as ICC (eribulin, capecitabine, vinorelbine, gemcitabine)
  • At least 1 measurable lesion not previously irradiated 
  • Minimum life expectancy of 12 weeks at screening

Exclusion Criteria
  • Any evidence of diseases which (such as severe or uncontrolled systemic diseases, uncontrolled hypertension, history of allogeneic organ transplant, and active bleeding diseases, ongoing or active infection, or significant or cardiac or psychological conditions
  • History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before of the first dose of study intervention and of low potential risk for recurrence
  • Persistent side effects caused by previous anticancer therapy that have not yet resolved
  • Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, suspected infections; or inability to rule out infections
  • Known active or uncontrolled hepatitis B or C infections; or positive for hepatitis B or C virus based on the evaluation of results of tests for hepatitis B or hepatitis C infection at screening
  • Known HIV infection that is not well controlled
  • Uncontrolled or significant cardiac disease, including MI or uncontrolled/unstable angina within 6 months prior to cycle 1 day 1
  • Participation in another clinical study with a study intervention or investigational drug administered

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Participating Locations
Cancer Center and Research Institute - UMMC
University Hospital - UMMC
Contact Information
Contact Name: Jessie Solise
Phone Number: 601-984-1963
Principal Investigator:Shou-Ching Tang
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