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

Running, not enrolling · Phase 3

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT06112379

Run by

AstraZeneca

People needed

1902

Starts

2023-11-14

Expected to finish

2032-09-23

Last updated by the study team

2026-07-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant must be ≥ 18 years, at the time of signing the ICF.
• Histologically confirmed Stage II or III unilateral or bilateral primary invasive TNBC or hormone receptor-low/HER2-negative breast cancer
• ECOG PS of 0 or 1
• Provision of acceptable tumor sample
• Adequate bone marrow reserve and organ function
• Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies and aligned with protocol requirements.

You may not qualify if…

• History of any prior invasive breast malignancy
• History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 5 years before randomization.
• active or prior documented autoimmune or inflammatory disorders.
• Evidence of distant disease.
• Clinically significant corneal disease.
• Has active or uncontrolled hepatitis B or C virus infection.
• Known HIV infection that is not well controlled.
• Uncontrolled infection requiring i.v. antibiotics, antivirals or antifungals; suspected infections; or inability to rule out infections.
• Known to have active tuberculosis infection
• Mean resting corrected QTcF interval > 470 ms obtained from ECG
• Uncontrolled or significant cardiac disease.
• History of non-infectious ILD/pneumonitis
• Has severe pulmonary function compromise
• Any prior or concurrent surgery, radiotherapy or systemic anticancer therapy for TNBC or hormone receptor-low/HER2-negative breast cancer
• For females only: is pregnant (confirmed with positive serum pregnancy test) or breastfeeding, or planning to become pregnant.
• Female participants should refrain from breastfeeding from enrolment throughout the study and for at least 7 months after last dose of study intervention, or as dictated by local PI for SoC if longer.
• Concurrent use of systemic hormone replacement therapy or oral hormonal contraception

Where it is running

• Research Site — Prescott, Arizona, United States
• Research Site — Jonesboro, Arkansas, United States
• Research Site — Rogers, Arkansas, United States
• Research Site — Los Angeles, California, United States
• Research Site — Santa Barbara, California, United States
• Research Site — Santa Rosa, California, United States
• Research Site — Torrance, California, United States
• Research Site — Aurora, Colorado, United States
• Research Site — Longmont, Colorado, United States
• Research Site — Bridgeport, Connecticut, United States
• Research Site — New Haven, Connecticut, United States
• Research Site — Fort Myers, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — St. Petersburg, Florida, United States
• Research Site — West Palm Beach, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Des Moines, Iowa, United States
• Research Site — Edgewood, Kentucky, United States
• Research Site — Louisville, Kentucky, United States
• Research Site — Baton Rouge, Louisiana, United States
• Research Site — Annapolis, Maryland, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Grand Rapids, Michigan, United States
• Research Site — Traverse City, Michigan, United States
• Research Site — Daphne, Alabama, United States

Full record on ClinicalTrials.gov

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