# 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)

> **NCT05104866** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **AstraZeneca** · enrollment: 732 (actual)

## Conditions studied

- Breast Cancer

## Interventions

- **DRUG:** Dato-DXd
- **DRUG:** Capecitabine
- **DRUG:** Gemcitabine
- **DRUG:** Eribulin
- **DRUG:** Vinorelbine

## Key facts

- **NCT ID:** NCT05104866
- **Lead sponsor:** AstraZeneca
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2021-10-18
- **Primary completion:** 2024-07-24
- **Final completion:** 2026-07-31
- **Target enrollment:** 732 (ACTUAL)
- **Last updated:** 2026-05-05

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05104866

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05104866, "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)". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT05104866. Licensed CC0.

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