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

NCT07619066 ↗

Phase 2 Not yet recruiting 25 enrolled MedSIR Boehringer Ingelheim · collab

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2026-10-04
Primary completion: 2028-09-28
Completion: 2028-11-28

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Zongertinib	Small molecule	120 mg	Oral
Background	Fulvestrant	Small molecule	500 mg	Intravenous

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

Summary

Timeline

Drugs

Indications