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)

Condition studied

HR-positive/HER2-negative advanced breast cancer

Investigational medicinal product(s)

Every trial of Zongertinib, Goserelin and Fulvestrant across our registers →

Eligibility

Primary endpoint

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.

Endpoint detail

PFS: period from treatment initiation until to the first occurrence of disease progression as determined locally by the investigator assessment using RECIST v.1.1 or death from any cause, whichever occurs first., CBR: rate of participants with objective response (CR or PR), or stable disease for at least 24 weeks, as determined locally by the investigator using RECIST v.1.1., TTR: period from treatment initiation to the first objective tumor response (tumor shrinkage of ≥ 30%) observed for participants who achieved a CR or PR, as determined locally by the investigator using RECIST v.1.1., DoR: period from the first occurrence of a documented objective response to disease progression or death from any cause, whichever occurs first, as determined locally by the investigator using RECIST v.1.1., Best percentage of change from baseline in the size of target tumor lesions, defined as the biggest decrease, or smallest increase if no decrease will be observed, as determined locally by the investigator using RECIST v.1.1., OS: period from treatment initiation to death from any cause, as determined locally by the investigator.