A TWO-STAGE, SINGLE-ARM, PHASE II STUDY OF ZONGERTINIB PLUS FULVESTRANT IN PARTICIPANTS WITH HORMONE RECEPTOR-POSITIVE/HER2-NEGATIVE ADVANCED BREAST CANCER HARBORING HER2 MUTATIONS (AGATHA)
- Registry ID
- 2026-525328-10-00
- Source registry
- CTIS
- Status
- Authorised
- Phase
- PHASE2
- Study type
- INTERVENTIONAL
- Sponsor
- Medica Scientia Innovation Research S.L.
- Enrollment
- 25
- Last update
- 2026-08-13
Conditions
- Diseases [C] - Neoplasms [C04]
- HR-positive/HER2-negative advanced breast cancer
Primary outcomes
ORR, defined as the rate of participants with complete response (CR) or partial response (PR), as determined locally by the investigator using RECIST v.1.1.
Locations
- , , Spain
- , , Italy
- , , Germany
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