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Phase 1b/2, Multicenter, Open-label, Dose-Expansion Modular Study To Explore the Safety, Tolerability, and Anti-tumor Activity of HER3-DXd monotherapy and combinations in Patients with inoperable advanced breast cancer (ABC) after progression on T-DXd- (ICARUS BREAST 2)

Status
Recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505925-15-00
Acronym
2023/3668
Enrollment
150
Registered
2024-01-10
Start date
2024-03-21
Completion date
Unknown
Last updated
2025-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

and any hormone receptor (HR) status, Patients with HER2-positive (HER2-pos) (cohort 1) or HER2-low defined as a score 1+ on immunohistochemistry [IHC] or as an IHC score 2+ and negative results on in situ hybridization (ISH) (cohort 2) ABC, patients with HER2-pos tumors must have received prior treatment with trastuzumab (+/- pertuzumab) and taxanes and may have received T-DM1. Patients with HER2-low tumors must have received prior treatment with taxanes. Patients with HR-positive (HR+) and HER2-low tumor must have received prior treatment with endocrine therapy and CDK4/6 inhibitors., who have progressed on trastuzumab deruxtecan (T-DXd). In addition to previous T-DXd

Interventions

None listed

Sponsors

Institut Gustave Roussy
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026