Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Daiichi Sankyo
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
The primary objectives of the study are to demonstrate superiority of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy relative to neoadjuvant pembroli...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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.
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
November 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2032
Estimated Enrollment :
1902 Patients enrolled
Trial Details
Trial ID
NCT06112379
Start Date
November 14 2023
End Date
September 23 2032
Last Update
December 17 2025
Active Locations (283)
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1
Research Site
Daphne, Alabama, United States, 36526
2
Research Site
Prescott, Arizona, United States, 86301
3
Research Site
Jonesboro, Arkansas, United States, 72401
4
Research Site
Rogers, Arkansas, United States, 72758