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)

  • STATUS
    Recruiting
  • End date
    Jul 18, 2025
  • participants needed
    700
  • sponsor
    AstraZeneca
Updated on 19 June 2022
estrogen
measurable disease
carcinoma
endocrine therapy
hormone therapy
capecitabine
HER2
trastuzumab
antineoplastic
bisphosphonate
erbb2
vinorelbine
mammogram
her2/neu-negative breast cancer

Summary

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.

Description

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.

Details
Condition Breast Cancer
Treatment Capecitabine, Gemcitabine, Eribulin, Vinorelbine, Dato-DXd
Clinical Study IdentifierNCT05104866
SponsorAstraZeneca
Last Modified on19 June 2022

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