# A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer

Clinical trial · AstraZeneca

- Archive id: nct:NCT06112379
- Published: 2023-11-01
- Venue: ClinicalTrials.gov
- ClinicalTrials.gov: https://clinicaltrials.gov/study/NCT06112379
- Source URL: https://clinicaltrials.gov/study/NCT06112379
- Provenance: clinicaltrials

## Abstract

This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer.

_Abstract reproduced under ClinicalTrials.gov (U.S. National Library of Medicine), data processed 2026-10-29T09:00:05; modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters._

## Trial details

- status: ACTIVE_NOT_RECRUITING
- phase: PHASE3
- study type: INTERVENTIONAL
- enrollment: 1902
- sponsor: AstraZeneca
- conditions: Breast Cancer
- interventions: DRUG: Dato-DXd; DRUG: Durvalumab; DRUG: Pembrolizumab; DRUG: Doxorubicin; DRUG: Epirubicin; DRUG: Cyclophosphamide; DRUG: Paclitaxel; DRUG: Carboplatin; DRUG: Capecitabine; DRUG: Olaparib
- start date: 2023-11-14
- start date type: ACTUAL
- primary completion date: 2028-11-20
- has results: false
- data source: ClinicalTrials.gov
- data processed: 2026-10-29T09:00:05
- modifications: selected fields only; whitespace normalized; brief summary truncated to 2,000 characters

Topics: [Cancer Immunotherapy](https://space-kitty.com/topics/cancer-immunotherapy)

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