Phase 2
Completed N=8
A Study of ZW25 (Zanidatamab) With Palbociclib Plus Fulvestrant in Patients With HER2+/HR+ Advanced Breast Cancer
HER2+/HR+ Breast Cancer
Source: ClinicalTrials.gov NCT04224272 ↗
Enrolled (actual)
8
Serious AEs
15.7%
Results posted
Aug 2024
Primary outcomePrimary: Number of Participants With Dose-Limiting Toxicities — 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose-Limiting Toxicities |
1 | — |
| PRIMARY Number of Participants Reporting Grade 3 or Higher Treatment-emergent Adverse Events |
20; 16; 6; 3; 13; 8 | — |
| PRIMARY Progression-free Survival 6 |
34 | — |
| SECONDARY Number of Participants Reporting Any Treatment-emergent Adverse Event, Serious Adverse Event, and Adverse Event of Special Interest |
51; 8; 10 | — |
| SECONDARY Maximum Serum Concentration of ZW25 |
— | — |
| SECONDARY Trough Concentration of ZW25 |
— | — |
| SECONDARY Incidence of Anti-drug Antibodies (ADAs) |
— | — |
| SECONDARY Objective Response Rate |
— | — |
| SECONDARY Duration of Response |
— | — |
| SECONDARY Disease Control Rate |
— | — |
| SECONDARY Progression-free Survival |
— | — |
| SECONDARY Overall Survival |
— | — |
| SECONDARY Incidence of Lab Abnormalities |
— | — |
Eligibility Criteria
Inclusion Criteria
- Pathologically-confirmed diagnosis of breast cancer with evidence of locally advanced (unresectable) and/or metastatic disease. All patients in both Parts 1 and 2 must have HER2-positive and HR-positive disease.
- Received prior treatment with trastuzumab, pertuzumab, AND ado-trastuzumab emtansine (T-DM1); disease progression during or after the most recent prior therapy. Patients in any part of the study who did not receive pertuzumab or T-DM1 because of lack of access (e.g., due to insurance coverage or because they were treated prior to regulatory agency approval of the agent in a relevant indication) or due to medical ineligibility for treatment with T-DM1 (e.g., history of severe infusion reactions to trastuzumab, >/= Grade 2 peripheral neuropathy, or platelet count /= institutional standard of normal
Exclusion Criteria
- Prior treatment with trastuzumab, pertuzumab, lapatinib, T-DM1, or other anti-HER2-targeted therapy 470 ms
- Grade 2 or greater pneumonitis and/or interstitial lung disease, including pulmonary fibrosis, or other clinically significant infiltrative pulmonary disease not related to lung metastases
- Active hepatitis B or hepatitis C infection
- Acute or chronic uncontrolled renal disease, pancreatitis, or severe liver disease (Child-Pugh Class C)
- Known infection with Human Immunodeficiency Virus (HIV)-1 or HIV-2 (Exception: patients with well controlled-HIV [e.g., cluster of differentiation 4 (CD4)-positive T-cell count > 350 mm3 and undetectable viral load] are eligible.)
- Prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
- Brain metastases: Untreated central nervous system (CNS) metastases, symptomatic CNS metastases, or radiation treatment for CNS metastases within 4 weeks of start of study treatment. Stable, treated brain metastases are allowed (defined as patients who are off steroids and anticonvulsants and are neurologically stable for at least 1 month at the time of screening).
- History of or ongoing leptomeningeal disease
- Grade 3 or greater peripheral neuropathy
Data sourced from ClinicalTrials.gov (NCT04224272). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.