What question did this study set out to answer?

The trial aims to evaluate the safety and preliminary efficacy of patritumab deruxtecan in combination with anti-HER2 agents for HER2+ breast cancer.

February 19, 2026Clinical Cancer Research

Abstract PS5-12-23: Herthena-breast01: a phase 1b/2, multicenter, open-label, dose-finding study to evaluate the safety and antitumor activity of patritumab deruxtecan (HER3-DXd) in HER2+ unresectable locally advanced or metastatic breast cancer

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The trial aims to evaluate the safety and preliminary efficacy of patritumab deruxtecan in combination with anti-HER2 agents for HER2+ breast cancer.
Multicenter, open-label, dose-finding phase 1b/2 study.
Participants must have histologically confirmed HER2+ unresectable locally advanced or metastatic breast cancer.
Three arms based on previous anti-HER2 therapies received.
Monitoring of safety, pharmacokinetics, and antitumor activity.
Design includes dose escalation and de-escalation decisions.
Primary endpoints focus on evaluating safety, dose-limiting toxicities, and treatment discontinuations due to adverse events.
Secondary endpoints include pharmacokinetics of HER3-DXd and assessment of HER3-DXd antidrug antibodies.
Enrollment anticipating up to 27 participants per arm, beginning early 2025.

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Implication

Phase 1b/2 trial demonstrates safety and antitumor activity in HER2+ unresectable metastatic breast cancer, suggesting potential in later-line therapy.

Cite This Study

Tolaney et al. (2026) studied this question.

synapsesocial.com/papers/6996a898ecb39a600b3ef820 https://doi.org/10.1158/1557-3265.sabcs25-ps5-12-23

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Implication

Phase 1b/2 trial demonstrates safety and antitumor activity in HER2+ unresectable metastatic breast cancer, suggesting potential in later-line therapy.

Abstract PS5-12-23: Herthena-breast01: a phase 1b/2, multicenter, open-label, dose-finding study to evaluate the safety and antitumor activity of patritumab deruxtecan (HER3-DXd) in HER2+ unresectable locally advanced or metastatic breast cancer

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Discussion

Implication

Cite This Study

Abstract PS5-12-23: Herthena-breast01: a phase 1b/2, multicenter, open-label, dose-finding study to evaluate the safety and antitumor activity of patritumab deruxtecan (HER3-DXd) in HER2+ unresectable locally advanced or metastatic breast cancer

Key Points

Discussion

Implication

Cite This Study

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