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)

ClinicalTrials.gov ID: NCT05104866

Public ClinicalTrials.gov record NCT05104866. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 19, 2026, 1:15 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT05104866
Recruitment status: Active, not recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: AstraZeneca; Industry
Enrollment: 732 participants

Conditions and interventions

Conditions

Breast Cancer

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 18, 2021 (Actual)
Primary completion: Jul 24, 2024 (Actual)
Completion: Dec 31, 2026 (Estimated)
Last update posted: Aug 24, 2026

2021 – 2026

United States locations

U.S. sites: 14
U.S. states: 10
U.S. cities: 13

Facility	City	State	ZIP	Site status
Research Site	Duarte	California	91010	—
Research Site	Los Angeles	California	90095	—
Research Site	Palo Alto	California	94305-5826	—
Research Site	San Francisco	California	94143	—
Research Site	Jacksonville	Florida	32207	—
Research Site	Atlanta	Georgia	30322	—
Research Site	Boston	Massachusetts	02114	—
Research Site	Boston	Massachusetts	02215	—
Research Site	Grand Rapids	Michigan	49503	—
Research Site	New York	New York	10065	—
Research Site	Cleveland	Ohio	44119	—
Research Site	Portland	Oregon	97239	—
Research Site	Nashville	Tennessee	37203	—
Research Site	Richmond	Virginia	23219	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 153 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05104866, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 24, 2026 · Synced Oct 19, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05104866 live on ClinicalTrials.gov.

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