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

Phase 1

Recruiting

• Conditions: Triple Negative or Hormone Receptor low/HER2-negative Breast Cancer; MedDRA version: 20.0Level: PTClassification code: 10075566Term: Triple negative breast cancer Class: 100000004864; MedDRA version: 20.0Level: SOCClassification code: 10029104Term: Neoplasms benign malignant and unspecified (incl cysts and polyps) Class: 2; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-505928-59-00
• Lead Sponsor: Astrazeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-17
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1728

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 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

Exclusion Criteria

History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before randomisation and of low potential risk for recurrence; 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; Known to have active tuberculosis infection; Resting ECG with clinically significant abnormal findings; Uncontrolled or significant cardiac disease; History of non-infectious ILD/pneumonitis; 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified