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)

Titre officiel

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)

Sommaire:

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 de l'essai

Primary Outcome:

  • Progression Free Survival
  • Overall Survival
Secondary Outcome:
  • Objective Response Rate (ORR)
  • Duration of Response (DoR)
  • Progression-Free Survival by Investigator assessment
  • Disease Control Rate (DCR)
  • Time to First Subsequent Therapy (TFST)
  • Time to Second Subsequent Therapy (TSST)
  • Time from randomization to second progression or death (PFS2)
  • Clinical Outcome Assessment- TTD in pain
  • Pharmacokinetics of Dato-DXd
  • Immunogenicity
  • Clinical Outcome Assessment- TTD in physical Functioning
  • Clinical Outcome Assessment- TTD in GHS
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.

Voir cet essai sur ClinicalTrials.gov

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