TROPION-Lung01 Study Design and Baseline demographics
Daiichi-Sankyo
TROPION-Breast01 Study Design1
Randomised, phase 3, open-label, global study (NCT05104866)
Key inclusion criteria:
•
Patients with HR+/HER2- breast cancer*
(HER2-defined as IHC 0/1+/2+; ISH negative)
1:1
Previously treated with 1-2 lines of
chemotherapy (inoperable/metastatic setting)
Experienced progression on ET and for whom
ET was unsuitable
ECOG PS 0 or 1
Dato-DXd
6 mg/kg IV Day 1 Q3W
(n=365)
Investigator's choice of
chemotherapy (ICC)
as per protocol directions*
(eribulin mesylate D1,8 Q3W; vinorelbine D1,8 Q3W;
gemcitabine D1,8 Q3W; capecitabine D1-14 Q3W)
(n=367)
•
Endpoints:
Dual primary: PFS by
BICR per RECIST
v1.1, and OS
•
Key secondary:
ORR, PFS
(investigator
assessed) and safety
Randomisation stratified by:
"
"
Lines of chemotherapy in unresectable/metastatic setting (1 vs 2)
Geographic location (US/Canada/Europe vs ROW)
•
Previous CDK4/6 inhibitor (yes vs no)
⚫ Treatment continued until PD, unacceptable tolerability, or other discontinuation criteria
Detailed description of the statistical methods published previously 1 *Per American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines. TICC was administered as follows: eribullin mesylate,
1.4 mg/m² IV on Days 1 and 8, Q3W; capecitabine, 1000 or 1250 mg/m² orally twice daily on Days 1 to 14, Q3W (dose per standard institutional practice); vinorelbine, 25 mg/m² IV on Days 1 and 8, Q3W; or gemcitabine,
1000 mg/m² IV on Days 1 and 8, Q3W. BICR, blinded independent central review; CDK4/6, cyclin-dependent kinase 4/6; ECOG PS, Eastern Cooperative Oncology Group performance status; ET, endocrine therapy;
IV, intravenous; ORR, objective response rate; OS, overall survival; PD, progressive disease; PFS, progression-free survival; RECIST, Response Evaluation Criteria in Solid Tumors; ROW, rest of world.
1. Bardia A, et al. Future Oncol 2023;
doi: 10.2217/fon-2023-0188.
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