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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)


Active: Yes
Cancer Type: Breast Cancer NCT ID: NCT05104866
Trial Phases: Phase III Protocol IDs: D9268C00001 (primary)
NCI-2021-14072
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: AstraZeneca Pharmaceuticals LP
NCI Full Details: http://clinicaltrials.gov/show/NCT05104866

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.

Objectives

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.
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.