Clinical Trial

A Phase II Study of Zongertinib Plus Fulvestrant in Participants With HR-positive/HER2-negative Advanced Breast Cancer Harboring HER2 Mutations.

Study acronym: AGATHA
Not Yet Recruiting Phase 2
View on ClinicalTrials.gov →
Summary
An international, multicenter, two-stage optimal Simon's design, single-arm phase II clinical trial to evaluate zongertinib plus fulvestrant combination therapy in participants with hormone receptor-positive/HER2-negative advanced breast cancer harboring HER2 mutations.
Trial Details
NCT Number NCT07619066
Lead Sponsor MedSIR
Collaborators: Boehringer Ingelheim
Conditions Advanced Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer, HER2 Mutation
Enrollment 25 participants
Start Date 2026-10-04
Primary Completion 2028-09-28 (estimated)
Study Completion 2028-11-28 (estimated)
Updated on ClinicalTrials.gov 2026-06-01