Study identifier:D926XC00001
ClinicalTrials.gov identifier:NCT05629585
EudraCT identifier:2022-002680-30
CTIS identifier:N/A
A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (DatoDXd) With or Without Durvalumab Versus Investigator’s Choice of Therapy in Patients with Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPION-Breast03)
Breast Cancer
Phase 3
No
Dato-DXd, Durvalumab, Capecitabine, Pembrolizumab
All
1075
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
Daiichi Sankyo, Inc, SWOG Clinical Trials Partnerships
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Dato-DXd in combination with Durvalumab Arm 1: Dato-DXd 6 mg/kg IV Q3W x 8 cycles + Durvalumab 1120 mg IV Q3W x 9 cycles | Drug: Dato-DXd Experimental drug. Provided in 100mg vials. IV infusion Other Name: Datopotamab deruxtecan (Dato-DXd, DS-1062a) Drug: Durvalumab Experimental drug. Provided in 50mg vials. IV infusion Other Name: MEDI4736 |
Experimental: Dato-DXd Arm 2: Dato-DXd 6 mg/kg IV Q3W x 8 cycles | Drug: Dato-DXd Experimental drug. Provided in 100mg vials. IV infusion Other Name: Datopotamab deruxtecan (Dato-DXd, DS-1062a) |
Active Comparator: Investigators Choice Therapy Arm 3: Capecitabine (1000 or 1250 mg/m2 oral BID on Days 1 to 14, Q3W) for 8 cycles Pembrolizumab* (200 mg IV on Day 1, Q3W) for 9 cycles Capecitabine (1000 or 1250 mg/m2 oral BID on Days 1 to 14, Q3W) for 8 cycles + pembrolizumab* (200 mg IV on Day 1, Q3W) for 9 cycles * Only participants who have received prior pembrolizumab in the neoadjuvant setting should receive pembrolizumab as part of their adjuvant therapy on Arm 3. | Drug: Capecitabine Active Comparator. Tablet. Oral route of administration Other Name: XELODA®, Capecitabine Cell Pharm, Capecitabine EG, Capecitabine Accord Drug: Pembrolizumab Active Comparator. Provided in 100mg vials. IV infusion Other Name: KEYTRUDA® |