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Phase III, randomized, multicenter, open-label study to evaluate DB-1303 versus investigator's choice of chemotherapy in patients with metastatic breast cancer
THE PRIMARY OBJECTIVE IS TO EVALUATE THE EFFICACY OF DB-1303 COMPARED TO INVESTIGATOR'S CHOICE OF CHEMOTHERAPY IN TERMS OF A HAZARD RATIO (HR) FOR PROGRESSION-FREE SURVIVAL (PFS) ASSESSED BY BLINDED INDEPENDENT CENTRAL REVIEW (BICR) IN THE HR+, HER2-LOW POPULATION (IHC 2+ AND IHC 1+). THE INTERCURRENT EVENT OF INITIATING SUBSEQUENT ANTICANCER THERAPY WILL FOLLOW A HYPOTHETICAL STRATEGY, AND STUDY TREATMENT DISCONTINUATION WILL FOLLOW A TREATMENT POLICY STRATEGY.
Technical Summary
- PHASE III, RANDOMIZED, MULTICENTER, OPEN-LABEL STUDY TO EVALUATE DB-1303 VERSUS INVESTIGATOR'S CHOICE OF CHEMOTHERAPY IN PATIENTS WITH METASTATIC BREAST CANCER WITH LOW HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 (HER2) EXPRESSION AND HORMONE RECEPTOR-POSITIVE (HR+) WHOSE CANCER HAS PROGRESSED ON ENDOCRINE THERAPY (DYNASTY-BREAST02)
- Code EudraCT: 2023-507333-17
- Protocol number: DB-1303-O-3002
- Promoter: DUALITYBIO INC. (Duality)
- Molecule/Drug: DB-1303
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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