MedTrace Logo

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

NCT07619066 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-06-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Zongertinib (BI 1810631)

120 mg of zongertinib orally once daily

DRUG

Fulvestrant

500 mg of fulvestrant IV on days 1 and 15 of the first cycle and once monthly thereafter

Sponsors & Collaborators

Principal Investigators

  • Javier Cortés, MD, PhD · Institute of Breast Cancer, Quirón Group, Barcelona (Spain)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07619066 on ClinicalTrials.gov