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

Sponsor
MedSIR
Study ID
NCT07619066
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Advanced Breast Cancer
  • HER2 Mutation
  • Hormone Receptor Positive / HER2-negative Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zongertinib (BI 1810631) — DRUG
    120 mg of zongertinib orally once daily
  • Fulvestrant — DRUG
    500 mg of fulvestrant IV on days 1 and 15 of the first cycle and once monthly thereafter

Study Details

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.

Key Dates

First listed
Jun 1, 2026
Start date
Oct 4, 2026
Status verified
May 2026
Primary completion
Sep 28, 2028
Completion
Nov 28, 2028

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: zongertinib plus fulvestrant
    120 mg of zongertinib PO once daily plus 500 mg of fulvestrant IV on days 1 and 15 of the first cycle and once monthly thereafter

Primary Outcome Measure

Investigator-assessed objective response rate (ORR). [ Time Frame: From treatment initiation until 6 months after last participant starts study treatments unless premature termination of the study. ]

Central Contacts

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