A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab Injections Before and After Surgery for the Treatment of Adult Patients with Breast Cancer

Laborértékek

• History of any prior invasive breast malignancy - History of another primary malignancy except for non-breast malignancy treated with curative intent with no known active disease within 5 years before randomisation - Evidence of distant disease. - Clinically significant corneal disease. - Has active or uncontrolled hepatitis B or C virus. - Known HIV infection that is not well controlled. - Uncontrolled infection requiring i.v. antibiotics, antivirals or antifungals - 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 any 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

• 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 tumour 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 in alignment with protocol requirements.