NCT04224272

A Study of ZW25 (Zanidatamab) With Palbociclib Plus Fulvestrant in Patients With HER2+/HR+ Advanced Breast Cancer

Phase 2a Study of ZW25 in Combination With Palbociclib Plus Fulvestrant

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Jazz Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, Phase 2a, open-label, 2-part study to investigate the safety, tolerability, and anti-tumor activity of ZW25 (zanidatamab) in combination with palbociclib plus fulvestrant. Eligible patients include those with locally advanced (unresectable) and/or metastatic human epidermal growth factor receptor 2 (HER2)-positive, hormone receptor (HR)-positive breast cancer.

Detailed description

Part 1 of the study will first evaluate the safety and tolerability of ZW25 in combination with palbociclib plus fulvestrant and will confirm the recommended doses (RDs) of ZW25 and palbociclib in this combination. Part 2 of the study will evaluate the anti-tumor activity of the combination of ZW25 with palbociclib plus fulvestrant at the RD level in patients with HER2-positive, HR-positive advanced breast cancer.

Conditions

• HER2+/HR+ Breast Cancer

Interventions

Type	Name	Description
DRUG	ZW25 (Zanidatamab)	Administered intravenously
DRUG	Palbociclib	Administered orally
DRUG	Fulvestrant	Administered as an intramuscular injection

Timeline

• Start date: 2020-06-10
• Primary completion: 2023-04-28
• Completion: 2025-06-30
• First posted: 2020-01-13
• Last updated: 2025-08-01
• Results posted: 2024-08-14

Locations

13 sites across 3 countries: United States, Canada, Spain

Regulatory

• FDA-regulated drug study