A Study of Dato-DXd With or Without Durvalumab Versus Investigator’s Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy

Phase 1

Recruiting

• Conditions: Stage I-III Triple-negative Breast Cancer with residual invasive disease after neoadjuvant systemic therapy.; MedDRA version: 20.0Level: PTClassification code: 10075566Term: Triple negative breast cancer Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-505552-22-00
• Lead Sponsor: Astrazeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-17
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1075

Inclusion Criteria

1.Participant must be = 18 years at the time of screening; Male or female 2.Histologically confirmed invasive TNBC 3.Residual invasive disease in the breast and/or axillary lymph node (s) at surgical resection following neoadjuvant therapy 4.Completed at least 6 cycles of neoadjuvant therapy containing an anthracycline and/or taxane with or without platinum chemotherapy, with or without pembrolizumab. 5.No evidence of locoregional or distance relapse 6.Surgical removal of all clinically evident disease in the breast and lymph nodes 7.FFPE tumor sample from residual invasive disease at surgery 8.No adjuvant systemic therapy. Radiotherapy (if indicated) delivered before start of study treatment 9.No more than 6 weeks between completion of post-operative radiation therapy and randomization. If no post-operative radiation therapy, no more than 16 weeks between the date of breast surgery and randomization 10.Eligible for one of the therapy options listed as ICT 11.No known germline BRCA1 or BRCA2 pathogenic mutation 12.Adequate organ and bone marrow function; LVEF = 50% by echocardiogram or MUGA; ECOG 0 or 1

Exclusion Criteria

1.Stage IV (metastatic) TNBC 2.History of prior invasive breast cancer or evidence of recurrent disease following preoperative therapy and surgery 3.Prior anticancer therapy with topoisomerase I ADC, TROP2-targeted therapy (e.g., Trodelvy), participated in clinical studies with T-DXd 4.Prior exposure to a PD-1/PD-L1 inhibitor other than pembrolizumab 5.Severe or uncontrolled medical conditions including systemic diseases, history of allogeneic organ transplant and active bleeding diseases, ongoing or active infection, serious chronic gastrointestinal conditions associated with diarrhea; infections; active or uncontrolled HBV or HCV uncontrolled HIV; active TB 6.Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved to Grade =1 7.History of ILD or severe pulmonary function compromise 8.Clinically significant corneal disease 9.Any known active or prior documented autoimmune or inflammatory disorders 10.Any known active liver disease 11.Uncontrolled or significant cardiac disease 12.Grade =2 peripheral neuropathy of any etiology 13.History of severe hypersensitivity to either drug substances or inactive ingredients of Dato-DXd or history of hypersensitivity to PD- 1/PD-L1 inhibitors or capecitabine

Study & Design

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