Phase I trial of neratinib plus palbociclib in advanced cancers with HER family alterations

Combination therapy with neratinib and palbociclib demonstrated a favorable safety profile and clinical benefit rate in patients with HER-driven alterations. Pharmacokinetic analysis revealed a CYP3A4-mediated drug-drug interaction, leading to reduced clearance and increased plasma exposure of both agents, underscoring the importance of considering metabolic interactions in future clinical development.

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Publication Details

Journal
ESMO Open
Published
2025-11-13
DOI
https://doi.org/10.1016/j.esmoop.2025.105895
Primary Topic
Advanced Breast Cancer Therapies
Type
article
Field-Weighted Citation Impact
0.00
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article

Phase I trial of neratinib plus palbociclib in advanced cancers with HER family alterations

Aung Naing, Michael Murphy, P T Soliman, Sarina A. Piha‐Paul et al.
ESMO Open
Advanced Breast Cancer Therapies
article

Phase I trial of neratinib plus palbociclib in advanced cancers with HER family alterations

Aung Naing, Michael Murphy, P T Soliman, Sarina A. Piha‐Paul, Siqing Fu, David Ramírez, Hai T. Tran, Timothy Anthony Yap, F. Meric-Bernstam, Anil K. Sood, Jae Yun Lim, Chieh Tseng, Ecaterina E Ileana Dumbrava
article en

Abstract

Combination therapy with neratinib and palbociclib demonstrated a favorable safety profile and clinical benefit rate in patients with HER-driven alterations. Pharmacokinetic analysis revealed a CYP3A4-mediated drug-drug interaction, leading to reduced clearance and increased plasma exposure of both agents, underscoring the importance of considering metabolic interactions in future clinical development.

ESMO OpenVol. 10(12)
The University of Texas MD Anderson Cancer Center (US)
Openalex Percentile: Top 51%
Advanced Breast Cancer Therapies
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